CompletedPhase 2Results posted
A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
108
Recruiting sites
-
Actual enrollment
308
Study population
Type 1 diabetes
Eligibility highlights
-
Primary endpoint
•C-peptide AUC
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT02443155
Org study IDNN9828-4150
Secondary ID2014-001215-39
Secondary IDREec-2015-1768Spanish registry
Secondary IDU1111-1154-7172WHO
Timeline
Milestones
Study first posted2015-05-13estimated
Study start2015-11-10actual
Primary completion2018-08-31actual
Study completion2019-02-27actual
Results first posted2021-01-11actual
Last update posted2021-04-09actual
Assets
Investigational agents
Who this study enrolls
Type 1 diabetes
Who can enroll
Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
•Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2
•BMI (body mass index) higher or equal to 18.5 kg/m^2
•Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
•Insulin dependence unless in temporary spontaneous remission (honeymoon period)
Exclusion criteria
•Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
•History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
•History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
•Vaccination within 4 weeks before randomisation, Visit 3 (V3)
•Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
•History of pancreatitis (acute or chronic)
•Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
•Any past or current diagnosis of malignant neoplasms
•Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo
Endpoints (230)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
96
Glycemic / diabetes
46
Cardiometabolic biomarkers
34
Other (unclassified)
25
MASH / liver
9
Renal / kidney
7
Patient-reported / QoL
6
Other clinical outcomes
5
Weight & body composition
2
Weight & body composition
2 endpointsSecondary/registry result
Change in Body Weight (kg)
Time frame:(Week 0, week 54) and (week 0, week 80)
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Mean · Kilogram (Kg) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | -1.8 | - |
| Change from week 0 to week 80 | 1.9 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.2 | - |
| Change from week 0 to week 80 | 1.6 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | -2.5 | - |
| Change from week 0 to week 80 | 0.4 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.1 | - |
| Change from week 0 to week 80 | 2.8 | - |
Secondary/protocol endpoint
Change in Body Weight (kg)
Time frame:(Week 0, week 54) and (week 0, week 80)
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
46 endpointsPrimary/registry result
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 54
C-peptide AUC
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.934 | - |
| NNC0114-0006 (Experimental) | 0.783 | - |
| Liraglutide (Experimental) | 0.709 | - |
| Placebo (Placebo) | 0.660 | - |
Treatment ratio1.4895% CI1.16 - 1.89p=0.0017Mixed model repeated measurements
Treatment ratio1.2395% CI0.97 - 1.57p=0.0927Mixed model repeated measurements
Treatment ratio1.1295% CI0.87 - 1.42p=0.3780Mixed model repeated measurements
Treatment ratio1.2095% CI0.94 - 1.53p=0.1377Mixed model repeated measurements
Treatment ratio1.3395% CI1.04 - 1.69p=0.0214Mixed model repeated measurements
Treatmrnt ratio1.1095% CI0.87 - 1.41p=0.4187Mixed model repeated measurements
Primary/protocol endpoint
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 54
C-peptide AUC
ratio, improvement
Secondary/registry result
AUC0-2h of C-peptide at Week 54 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 54
C-peptide AUC
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.961 | - |
| NNC0114-0006 (Experimental) | 0.824 | - |
| Liraglutide (Experimental) | 0.646 | - |
| Placebo (Placebo) | 0.655 | - |
Secondary/registry result
Cmax of C-peptide at Week 54 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 54
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of Cmax | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.978 | - |
| NNC0114-0006 (Experimental) | 0.779 | - |
| Liraglutide (Experimental) | 0.733 | - |
| Placebo (Placebo) | 0.644 | - |
Secondary/registry result
AUC0-4h of Glucose at Week 54 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 54
Postprandial glucose
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.904 | - |
| NNC0114-0006 (Experimental) | 1.078 | - |
| Liraglutide (Experimental) | 0.993 | - |
| Placebo (Placebo) | 1.089 | - |
Secondary/registry result
AUC0-2h of Glucose at Week 54 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 54
Postprandial glucose
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.939 | - |
| NNC0114-0006 (Experimental) | 1.066 | - |
| Liraglutide (Experimental) | 0.978 | - |
| Placebo (Placebo) | 1.057 | - |
Secondary/registry result
Cmax of Glucose at Week 54 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 54
Postprandial glucose
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of Cmax | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.937 | - |
| NNC0114-0006 (Experimental) | 1.068 | - |
| Liraglutide (Experimental) | 1.004 | - |
| Placebo (Placebo) | 1.057 | - |
Secondary/registry result/low confidence
Change in Insulin Dose
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Posted result
| Group | Mean · Units per kilograms | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | -0.05 | - |
| Change from week 0 to week 80 | 0.10 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.02 | - |
| Change from week 0 to week 80 | 0.05 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.01 | - |
| Change from week 0 to week 80 | 0.11 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.09 | - |
| Change from week 0 to week 80 | 0.12 | - |
Secondary/registry result
Change in Number of Insulin Injections
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Posted result
| Group | Mean · Injections per day | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | -0.3 | - |
| Change from week 0 to week 80 | 0.2 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | -0.1 | - |
| Change from week 0 to week 80 | -0.3 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | -0.5 | - |
| Change from week 0 to week 80 | -0.2 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.2 | - |
| Change from week 0 to week 80 | 0.2 | - |
Secondary/registry result
Number of Weeks Off Bolus Insulin
Time frame:(Week 0 to week 54) and (week 0 to week 80)
descriptive, improvement
Posted result
| Group | Mean · Weeks | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 to week 54 | 10 | - |
| Week 0 to week 80 | 14 | - |
| NNC0114-0006 (Experimental)Week 0 to week 54 | 5 | - |
| Week 0 to week 80 | 9 | - |
| Liraglutide (Experimental)Week 0 to week 54 | 9 | - |
| Week 0 to week 80 | 12 | - |
| Placebo (Placebo)Week 0 to week 54 | 4 | - |
| Week 0 to week 80 | 6 | - |
Secondary/registry result
Change in HbA1c
Time frame:(Week 0, week 54) and (week 0, week 80)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Mean · Percentage point of HbA1c | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | -0.7 | - |
| Change from week 0 to week 80 | -0.1 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | -0.5 | - |
| Change from week 0 to week 80 | -0.2 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | -0.3 | - |
| Change from week 0 to week 80 | 0.5 | - |
| Placebo (Placebo)Change from week 0 to week 54 | -0.3 | - |
| Change from week 0 to week 80 | -0.4 | - |
Secondary/registry result
Change in Fasting Plasma Glucose
Time frame:(Week 0, week 54) and (week 0, week 80)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.5 | - |
| Change from week 0 to week 80 | 1.1 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.2 | - |
| Change from week 0 to week 80 | 0.3 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | -0.3 | - |
| Change from week 0 to week 80 | 0.2 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.5 | - |
| Change from week 0 to week 80 | 1.0 | - |
Secondary/registry result
Change in Fasting C-peptide- Ratio to Baseline
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of C-peptide | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Ratio from week 0 to week 54 | 1.01 | - |
| Ratio from week 0 to week 80 | 0.58 | - |
| NNC0114-0006 (Experimental)Ratio from week 0 to week 54 | 0.70 | - |
| Ratio from week 0 to week 80 | 0.53 | - |
| Liraglutide (Experimental)Ratio from week 0 to week 54 | 0.65 | - |
| Ratio from week 0 to week 80 | 0.42 | - |
| Placebo (Placebo)Ratio from week 0 to week 54 | 0.66 | - |
| Ratio from week 0 to week 80 | 0.54 | - |
Secondary/registry result
Change in Fasting Glucagon- Ratio to Baseline
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Posted result
| Group | Geometric mean · Ratio of glucagon | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Ratio from week 0 to week 54 | 1.01 | - |
| Ratio from week 0 to week 80 | 0.89 | - |
| NNC0114-0006 (Experimental)Ratio from week 0 to week 54 | 0.95 | - |
| Ratio from week 0 to week 80 | 0.85 | - |
| Liraglutide (Experimental)Ratio from week 0 to week 54 | 0.96 | - |
| Ratio from week 0 to week 80 | 0.96 | - |
| Placebo (Placebo)Ratio from week 0 to week 54 | 1.00 | - |
| Ratio from week 0 to week 80 | 0.93 | - |
Secondary/registry result
7-point SMPG Profiles
Time frame:Week 54 and Week 80
Postprandial glucose
descriptive
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 54: Before breakfast | 6.8 | - |
| Week 54: 90 minutes after start of breakfast | 8.9 | - |
| Week 54: Before lunch | 5.5 | - |
| Week 54: 90 minutes after start of lunch | 8.2 | - |
| Week 54: Before dinner | 6.5 | - |
| Week 54: 90 minutes after start of dinner | 8.2 | - |
| Week 54: Bedtime | 7.8 | - |
| Week 80: Before breakfast | 6.5 | - |
| Week 80: 90 minutes after start of breakfast | 8.5 | - |
| Week 80: Before lunch | 6.2 | - |
| Week 80: 90 minutes after start of lunch | 7.8 | - |
| Week 80: Before dinner | 6.5 | - |
| Week 80: 90 minutes after start of dinner | 7.6 | - |
| Week 80: Bedtime | 7.8 | - |
| NNC0114-0006 (Experimental)Week 54: Before breakfast | 6.8 | - |
| Week 54: 90 minutes after start of breakfast | 7.5 | - |
| Week 54: Before lunch | 6.4 | - |
| Week 54: 90 minutes after start of lunch | 7.5 | - |
| Week 54: Before dinner | 6.5 | - |
| Week 54: 90 minutes after start of dinner | 7.0 | - |
| Week 54: Bedtime | 7.4 | - |
| Week 80: Before breakfast | 6.4 | - |
| Week 80: 90 minutes after start of breakfast | 7.2 | - |
| Week 80: Before lunch | 6.2 | - |
| Week 80: 90 minutes after start of lunch | 7.6 | - |
| Week 80: Before dinner | 6.7 | - |
| Week 80: 90 minutes after start of dinner | 7.0 | - |
| Week 80: Bedtime | 6.6 | - |
| Liraglutide (Experimental)Week 54: Before breakfast | 6.4 | - |
| Week 54: 90 minutes after start of breakfast | 7.4 | - |
| Week 54: Before lunch | 6.1 | - |
| Week 54: 90 minutes after start of lunch | 7.8 | - |
| Week 54: Before dinner | 6.6 | - |
| Week 54: 90 minutes after start of dinner | 7.2 | - |
| Week 54: Bedtime | 7.5 | - |
| Week 80: Before breakfast | 7.2 | - |
| Week 80: 90 minutes after start of breakfast | 8.3 | - |
| Week 80: Before lunch | 6.9 | - |
| Week 80: 90 minutes after start of lunch | 8.5 | - |
| Week 80: Before dinner | 7.6 | - |
| Week 80: 90 minutes after start of dinner | 9.0 | - |
| Week 80: Bedtime | 7.8 | - |
| Placebo (Placebo)Week 54: Before breakfast | 6.3 | - |
| Week 54: 90 minutes after start of breakfast | 7.6 | - |
| Week 54: Before lunch | 6.0 | - |
| Week 54: 90 minutes after start of lunch | 7.7 | - |
| Week 54: Before dinner | 6.1 | - |
| Week 54: 90 minutes after start of dinner | 6.8 | - |
| Week 54: Bedtime | 7.2 | - |
| Week 80: Before breakfast | 6.8 | - |
| Week 80: 90 minutes after start of breakfast | 7.5 | - |
| Week 80: Before lunch | 6.1 | - |
| Week 80: 90 minutes after start of lunch | 8.0 | - |
| Week 80: Before dinner | 6.5 | - |
| Week 80: 90 minutes after start of dinner | 7.6 | - |
| Week 80: Bedtime | 7.4 | - |
Secondary/registry result
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
Time frame:(Week 0, week 54) and (week 0, week 80)
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54: Breakfast | 1.3 | - |
| Change from week 0 to week 80: Breakfast | 1.9 | - |
| Change from week 0 to week 54: Lunch | 0.9 | - |
| Change from week 0 to week 80: Lunch | 0.0 | - |
| Change from week 0 to week 54: Dinner | 0.1 | - |
| Change from week 0 to week 80: Dinner | 0.5 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54: Breakfast | 0.4 | - |
| Change from week 0 to week 80: Breakfast | 0.5 | - |
| Change from week 0 to week 54: Lunch | 0.5 | - |
| Change from week 0 to week 80: Lunch | 0.1 | - |
| Change from week 0 to week 54: Dinner | 1.1 | - |
| Change from week 0 to week 80: Dinner | 0.5 | - |
| Liraglutide (Experimental)Change from week 0 to week 54: Breakfast | -0.1 | - |
| Change from week 0 to week 80: Breakfast | -0.1 | - |
| Change from week 0 to week 54: Lunch | 1.5 | - |
| Change from week 0 to week 80: Lunch | 1.0 | - |
| Change from week 0 to week 54: Dinner | -0.8 | - |
| Change from week 0 to week 80: Dinner | -0.4 | - |
| Placebo (Placebo)Change from week 0 to week 54: Breakfast | -0.6 | - |
| Change from week 0 to week 80: Breakfast | -0.5 | - |
| Change from week 0 to week 54: Lunch | 0.7 | - |
| Change from week 0 to week 80: Lunch | 0.8 | - |
| Change from week 0 to week 54: Dinner | -0.3 | - |
| Change from week 0 to week 80: Dinner | -0.4 | - |
Secondary/registry result
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
Time frame:(Week 0, week 54) and (week 0, week 80)
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.9 | - |
| Change from week 0 to week 80 | 0.8 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.6 | - |
| Change from week 0 to week 80 | 0.4 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.2 | - |
| Change from week 0 to week 80 | 0.0 | - |
| Placebo (Placebo)Change from week 0 to week 54 | -0.1 | - |
| Change from week 0 to week 80 | -0.0 | - |
Secondary/registry result
Change in Mean of 7-point Profiles
Time frame:(Week 0, week 54) and (week 0, week 80)
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.5 | - |
| Change from week 0 to week 80 | 0.1 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.3 | - |
| Change from week 0 to week 80 | 0.0 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | -0.1 | - |
| Change from week 0 to week 80 | 0.7 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.0 | - |
| Change from week 0 to week 80 | 0.3 | - |
Secondary/registry result
Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
Time frame:Week 54 and week 80
Postprandial glucose
descriptive, improvement
Posted result
| Group | Mean · mmol/L | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 54 | 6.8 | - |
| Week 80 | 6.5 | - |
| NNC0114-0006 (Experimental)Week 54 | 6.8 | - |
| Week 80 | 6.4 | - |
| Liraglutide (Experimental)Week 54 | 6.4 | - |
| Week 80 | 7.2 | - |
| Placebo (Placebo)Week 54 | 6.3 | - |
| Week 80 | 6.8 | - |
Secondary/registry result
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 80
C-peptide AUC
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.566 | - |
| NNC0114-0006 (Experimental) | 0.598 | - |
| Liraglutide (Experimental) | 0.373 | - |
| Placebo (Placebo) | 0.571 | - |
Secondary/registry result
AUC0-2h of C-peptide at Week 80 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 80
C-peptide AUC
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.590 | - |
| NNC0114-0006 (Experimental) | 0.619 | - |
| Liraglutide (Experimental) | 0.370 | - |
| Placebo (Placebo) | 0.540 | - |
Secondary/registry result
Cmax of C-peptide at Week 80 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 80
C-peptide AUC
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of Cmax | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 0.580 | - |
| NNC0114-0006 (Experimental) | 0.592 | - |
| Liraglutide (Experimental) | 0.389 | - |
| Placebo (Placebo) | 0.568 | - |
Secondary/registry result
AUC0-4h of Glucose at Week 80 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 80
Postprandial glucose
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 1.129 | - |
| NNC0114-0006 (Experimental) | 1.115 | - |
| Liraglutide (Experimental) | 1.136 | - |
| Placebo (Placebo) | 1.221 | - |
Secondary/registry result
AUC0-2h of Glucose at Week 80 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 80
Postprandial glucose
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 1.119 | - |
| NNC0114-0006 (Experimental) | 1.086 | - |
| Liraglutide (Experimental) | 1.070 | - |
| Placebo (Placebo) | 1.166 | - |
Secondary/registry result
Cmax of Glucose at Week 80 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 80
Postprandial glucose
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of Cmax | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 1.114 | - |
| NNC0114-0006 (Experimental) | 1.074 | - |
| Liraglutide (Experimental) | 1.104 | - |
| Placebo (Placebo) | 1.155 | - |
Secondary/protocol endpoint
AUC0-2h of C-peptide at Week 54 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 54
C-peptide AUC
ratio, improvement
Secondary/protocol endpoint
Cmax of C-peptide at Week 54 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 54
ratio, improvement
Secondary/protocol endpoint
AUC0-4h of Glucose at Week 54 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 54
Postprandial glucose
ratio, improvement
Secondary/protocol endpoint
AUC0-2h of Glucose at Week 54 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 54
Postprandial glucose
ratio, improvement
Secondary/protocol endpoint
Cmax of Glucose at Week 54 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 54
Postprandial glucose
ratio, improvement
Secondary/protocol endpoint
Change in Insulin Dose
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Secondary/protocol endpoint
Change in Number of Insulin Injections
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Secondary/protocol endpoint
Change in HbA1c
Time frame:(Week 0, week 54) and (week 0, week 80)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Secondary/protocol endpoint
Change in Fasting Plasma Glucose
Time frame:(Week 0, week 54) and (week 0, week 80)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Secondary/protocol endpoint
Change in Fasting C-peptide- Ratio to Baseline
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint
7-point SMPG Profiles
Time frame:Week 54 and Week 80
descriptive
Secondary/protocol endpoint
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
Time frame:(Week 0, week 54) and (week 0, week 80)
Postprandial glucose
change from baseline, improvement
Secondary/protocol endpoint
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
Time frame:(Week 0, week 54) and (week 0, week 80)
Postprandial glucose
change from baseline, improvement
Secondary/protocol endpoint
Change in Mean of 7-point Profiles
Time frame:(Week 0, week 54) and (week 0, week 80)
Postprandial glucose
change from baseline, improvement
Secondary/protocol endpoint
Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
Time frame:Week 54 and week 80
descriptive
Secondary/protocol endpoint
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 80
C-peptide AUC
ratio, improvement
Secondary/protocol endpoint
AUC0-2h of C-peptide at Week 80 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 80
C-peptide AUC
ratio, improvement
Secondary/protocol endpoint
Cmax of C-peptide at Week 80 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 80
ratio, descriptive
Secondary/protocol endpoint
AUC0-4h of Glucose at Week 80 Relative to Baseline
Time frame:0 - 4 hours post-dose on week 0 and week 80
Postprandial glucose
ratio, improvement
Secondary/protocol endpoint
AUC0-2h of Glucose at Week 80 Relative to Baseline
Time frame:0-2 hours post-dose on week 0 and week 80
Postprandial glucose
ratio, improvement
Secondary/protocol endpoint
Cmax of Glucose at Week 80 Relative to Baseline
Time frame:0-4 hours post-dose on week 0 and week 80
ratio, improvement
MASH / liver
9 endpointsSecondary/registry result
Change in Biochemistry: Alanine Aminotransferase (ALAT)
Time frame:(Week 0, week 54) and (week 0, week 80)
ALT, change
ratio, improvement
LOINC 1742-6
Posted result
| Group | Geometric mean · ratio of ALT | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.95 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 1.06 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.90 | - |
| Change from week 0 to week 80 | 0.92 | - |
Secondary/registry result
Change in Biochemistry: Alkaline Phosphatase (ALP)
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of ALP | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.07 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.05 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.04 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.04 | - |
Secondary/registry result
Change in Biochemistry: Aspartate Aminotransferase (ASAT)
Time frame:(Week 0, week 54) and (week 0, week 80)
AST, change
ratio, improvement
LOINC 1920-8
Posted result
| Group | Geometric mean · Ratio of AST | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.09 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Biochemistry: Total Bilirubin
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · ratio of total bilirubin | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.81 | - |
| Change from week 0 to week 80 | 0.91 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.10 | - |
| Change from week 0 to week 80 | 1.04 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
Time frame:(Week 0, week 54) and (week 0, week 80)
γ-GT, change
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of GGT | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.05 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.08 | - |
| Change from week 0 to week 80 | 1.13 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.10 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/protocol endpoint
Change in Biochemistry: Alanine Aminotransferase (ALAT)
Time frame:(Week 0, week 54) and (week 0, week 80)
ALT, change
ratio, improvement
LOINC 1742-6
Secondary/protocol endpoint
Change in Biochemistry: Aspartate Aminotransferase (ASAT)
Time frame:(Week 0, week 54) and (week 0, week 80)
AST, change
ratio, improvement
LOINC 1920-8
Secondary/protocol endpoint
Change in Biochemistry: Total Bilirubin
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint
Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
Time frame:(Week 0, week 54) and (week 0, week 80)
γ-GT, change
ratio, improvement
Renal / kidney
7 endpointsSecondary/registry result
Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
Time frame:(Week 0, week 54) and (week 0, week 80)
eGFR, change
ratio, improvement
LOINC 98979-8
Posted result
| Group | Geometric mean · Ratio of eGFR | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.97 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.95 | - |
| Change from week 0 to week 80 | 0.94 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 0.96 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Biochemistry: Creatinine
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of Creatinine | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.02 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.05 | - |
| Change from week 0 to week 80 | 1.05 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 1.05 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.02 | - |
Secondary/registry result/low confidence
Change in Biochemistry: Phosphate
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of phosphate | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.02 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.01 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.03 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Biochemistry: Blood Urea Nitrogen Serum
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of Blood Urea Nitrogen serum | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.97 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.05 | - |
| Change from week 0 to week 80 | 0.97 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.94 | - |
| Change from week 0 to week 80 | 0.97 | - |
Secondary/protocol endpoint
Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
Time frame:(Week 0, week 54) and (week 0, week 80)
eGFR, change
ratio, improvement
LOINC 98979-8
Secondary/protocol endpoint
Change in Biochemistry: Creatinine
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint
Change in Biochemistry: Blood Urea Nitrogen Serum
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Cardiometabolic biomarkers
34 endpointsSecondary/registry result
Change in Biochemistry: C-reactive Protein Serum
Time frame:(Week 0, week 54) and (week 0, week 80)
hs-CRP, change
ratio, improvement
LOINC 30522-7
Posted result
| Group | Geometric mean · Ratio of C-reactive protein | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.92 | - |
| Change from week 0 to week 80 | 1.08 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 0.94 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.89 | - |
| Change from week 0 to week 80 | 1.25 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.06 | - |
| Change from week 0 to week 80 | 1.06 | - |
Secondary/registry result
Change in Biochemistry: Uric Acid
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of uric acid | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.93 | - |
| Change from week 0 to week 80 | 0.95 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.94 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.96 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.95 | - |
Secondary/registry result
Change in D-Dimer
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of D-dimer | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.96 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.92 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 1.05 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.15 | - |
| Change from week 0 to week 80 | 1.10 | - |
Secondary/registry result
Change in Lipids: Total Cholesterol (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Geometric mean · Ratio of total cholesterol | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.02 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.03 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.07 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 1.03 | - |
Secondary/registry result
Change in Lipids: Free Fatty Acids (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
Free fatty acids, change
ratio, improvement
Posted result
| Group | Geometric mean · Ratio of free fatty acids | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.86 | - |
| Change from week 0 to week 80 | 0.89 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.06 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.18 | - |
| Change from week 0 to week 80 | 1.19 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 0.94 | - |
Secondary/registry result
Change in Lipids: HDL Cholesterol (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Geometric mean · Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 1.04 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.08 | - |
| Change from week 0 to week 80 | 1.06 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.12 | - |
| Change from week 0 to week 80 | 1.14 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.10 | - |
| Change from week 0 to week 80 | 1.07 | - |
Secondary/registry result
Change in Lipids: LDL Cholesterol (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Geometric mean · Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.99 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.03 | - |
Secondary/registry result
Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Geometric mean · Ratio of TG | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.08 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.94 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.09 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 0.95 | - |
Secondary/registry result
Change in Cytokines: Interleukin (IL)-6
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Posted result
| Group | Mean · picogram per milliliter (pg/mL) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 0.9 | - |
| Week 54 | 0.8 | - |
| Week 80 | 0.9 | - |
| NNC0114-0006 (Experimental)Week 0 | 0.8 | - |
| Week 54 | 0.8 | - |
| Week 80 | 0.8 | - |
| Liraglutide (Experimental)Week 0 | 1.2 | - |
| Week 54 | 1.0 | - |
| Week 80 | 0.9 | - |
| Placebo (Placebo)Week 0 | 0.8 | - |
| Week 54 | 0.8 | - |
| Week 80 | 0.9 | - |
Secondary/registry result
Change in Cytokines- Interleukin (IL)-10
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · pg/mL | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 0.7 | - |
| Week 54 | 0.4 | - |
| Week 80 | 0.4 | - |
| NNC0114-0006 (Experimental)Week 0 | 0.5 | - |
| Week 54 | 0.4 | - |
| Week 80 | 0.4 | - |
| Liraglutide (Experimental)Week 0 | 0.4 | - |
| Week 54 | 0.4 | - |
| Week 80 | 0.5 | - |
| Placebo (Placebo)Week 0 | 0.4 | - |
| Week 54 | 0.4 | - |
| Week 80 | 0.4 | - |
Secondary/registry result
Change in Cytokines: Interleukin (IL)-17
Time frame:Week 0, week 54 and week 80
IL-17
change from baseline, descriptive
Posted result
| Group | Mean · pg/mL | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 4.9 | - |
| Week 54 | 4.9 | - |
| Week 80 | 4.9 | - |
| NNC0114-0006 (Experimental)Week 0 | 4.7 | - |
| Week 54 | 4.8 | - |
| Week 80 | 4.7 | - |
| Liraglutide (Experimental)Week 0 | 4.7 | - |
| Week 54 | 5.1 | - |
| Week 80 | 4.8 | - |
| Placebo (Placebo)Week 0 | 4.8 | - |
| Week 54 | 5.4 | - |
| Week 80 | 4.8 | - |
Secondary/registry result
Change in Cytokines: Interferon (IFN) Gamma
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · pg/mL | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 7.3 | - |
| Week 54 | 4.6 | - |
| Week 80 | 4.4 | - |
| NNC0114-0006 (Experimental)Week 0 | 7.8 | - |
| Week 54 | 7.5 | - |
| Week 80 | 4.9 | - |
| Liraglutide (Experimental)Week 0 | 5.8 | - |
| Week 54 | 5.0 | - |
| Week 80 | 13.0 | - |
| Placebo (Placebo)Week 0 | 4.3 | - |
| Week 54 | 5.8 | - |
| Week 80 | 4.5 | - |
Secondary/registry result
Change in Cytokines: TNF-alpha
Time frame:Week 0, week 54 and week 80
TNF-alpha
change from baseline, descriptive
Posted result
| Group | Mean · pg/mL | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 2.60 | - |
| Week 54 | 2.36 | - |
| Week 80 | 2.43 | - |
| NNC0114-0006 (Experimental)Week 0 | 2.32 | - |
| Week 54 | 2.33 | - |
| Week 80 | 2.36 | - |
| Liraglutide (Experimental)Week 0 | 2.70 | - |
| Week 54 | 2.56 | - |
| Week 80 | 2.96 | - |
| Placebo (Placebo)Week 0 | 3.06 | - |
| Week 54 | 2.43 | - |
| Week 80 | 2.75 | - |
Secondary/registry result
Change in Systolic and Diastolic Blood Pressure
Time frame:(Week 0, week 54) and (week 0, week 80)
Systolic BP, change
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
LOINC 8480-6
Posted result
| Group | Mean · Millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 54: Systolic blood pressure | -3 | - |
| Week 80: Systolic blood pressure | -1 | - |
| Week 54: Diastolic blood pressure | -0 | - |
| Week 80: Diastolic blood pressure | -0 | - |
| NNC0114-0006 (Experimental)Week 54: Systolic blood pressure | 3 | - |
| Week 80: Systolic blood pressure | 2 | - |
| Week 54: Diastolic blood pressure | 2 | - |
| Week 80: Diastolic blood pressure | 2 | - |
| Liraglutide (Experimental)Week 54: Systolic blood pressure | -2 | - |
| Week 80: Systolic blood pressure | 1 | - |
| Week 54: Diastolic blood pressure | -1 | - |
| Week 80: Diastolic blood pressure | 1 | - |
| Placebo (Placebo)Week 54: Systolic blood pressure | 1 | - |
| Week 80: Systolic blood pressure | 4 | - |
| Week 54: Diastolic blood pressure | -1 | - |
| Week 80: Diastolic blood pressure | 1 | - |
Secondary/registry result
Change in Pulse
Time frame:(Week 0, week 54) and (week 0, week 80)
Heart rate, change
change from baseline, improvement
Posted result
| Group | Mean · Beats/min | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 3 | - |
| Change from week 0 to week 80 | -1 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0 | - |
| Change from week 0 to week 80 | -1 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 6 | - |
| Change from week 0 to week 80 | 2 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 2 | - |
| Change from week 0 to week 80 | 1 | - |
Secondary/registry result
Change in Respiratory Rate
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Posted result
| Group | Mean · Breaths per minute | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | -0.3 | - |
| Change from week 0 to week 80 | -0.3 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.1 | - |
| Change from week 0 to week 80 | -0.2 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.1 | - |
| Change from week 0 to week 80 | 0.1 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.6 | - |
| Change from week 0 to week 80 | 0.1 | - |
Secondary/registry result
Change in Biomarker: Immune Phenotyping- B Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · Percentage of B cells (%) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Activated Memory B-Cells | 1.3 | - |
| Week 54: Activated Memory B-Cells | 1.2 | - |
| Week 80: Activated Memory B-Cells | 1.2 | - |
| Week 0: Mature Naive B-Cells | 15.1 | - |
| Week 54: Mature Naive B-Cells | 14.0 | - |
| Week 80: Mature Naive B-Cells | 14.3 | - |
| Week 0: Antibody-Secreting Cells | 0.6 | - |
| Week 54: Antibody-Secreting Cells | 0.6 | - |
| Week 80: Antibody-Secreting Cells | 0.5 | - |
| Week 0: B-Cells Positive For Both CD19 & CD20 | 71.9 | - |
| Week 54: B-Cells Positive For Both CD19 & CD20 | 71.1 | - |
| Week 80: B-Cells Positive For Both CD19 & CD20 | 71.0 | - |
| Week 0: CD20Neg B-Cell | 0.6 | - |
| Week 54: CD20Neg B-Cell | 0.6 | - |
| Week 80: CD20Neg B-Cell | 0.5 | - |
| Week 0: CD24- B-Cells | 29.8 | - |
| Week 54: CD24- B-Cells | 30.2 | - |
| Week 80: CD24- B-Cells | 30.0 | - |
| Week 0: Class-Switched Memory B Cells | 5.0 | - |
| Week 54: Class-Switched Memory B Cells | 5.0 | - |
| Week 80: Class-Switched Memory B Cells | 4.6 | - |
| Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 0: Non-Class Switched Memory B-Cells | 10.2 | - |
| Week 54: Non-Class Switched Memory B-Cells | 8.5 | - |
| Week 80: Non-Class Switched Memory B-Cells | 8.2 | - |
| Week 0: Total B-Cell Population | 72.5 | - |
| Week 54: Total B-Cell Population | 71.7 | - |
| Week 80: Total B-Cell Population | 71.4 | - |
| Week 0: Transitional B-Cells | 11.4 | - |
| Week 54: Transitional B-Cells | 10.2 | - |
| Week 80: Transitional B-Cells | 10.8 | - |
| NNC0114-0006 (Experimental)Week 0: Activated Memory B-Cells | 1.4 | - |
| Week 54: Activated Memory B-Cells | 1.1 | - |
| Week 80: Activated Memory B-Cells | 1.1 | - |
| Week 0: Mature Naive B-Cells | 14.0 | - |
| Week 54: Mature Naive B-Cells | 14.3 | - |
| Week 80: Mature Naive B-Cells | 14.2 | - |
| Week 0: Antibody-Secreting Cells | 0.5 | - |
| Week 54: Antibody-Secreting Cells | 0.4 | - |
| Week 80: Antibody-Secreting Cells | 0.4 | - |
| Week 0: B-Cells Positive For Both CD19 & CD20 | 71.1 | - |
| Week 54: B-Cells Positive For Both CD19 & CD20 | 70.8 | - |
| Week 80: B-Cells Positive For Both CD19 & CD20 | 69.8 | - |
| Week 0: CD20Neg B-Cell | 0.6 | - |
| Week 54: CD20Neg B-Cell | 0.5 | - |
| Week 80: CD20Neg B-Cell | 0.5 | - |
| Week 0: CD24- B-Cells | 31.0 | - |
| Week 54: CD24- B-Cells | 30.6 | - |
| Week 80: CD24- B-Cells | 31.6 | - |
| Week 0: Class-Switched Memory B Cells | 4.6 | - |
| Week 54: Class-Switched Memory B Cells | 4.2 | - |
| Week 80: Class-Switched Memory B Cells | 3.6 | - |
| Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.2 | - |
| Week 0: Non-Class Switched Memory B-Cells | 9.6 | - |
| Week 54: Non-Class Switched Memory B-Cells | 9.0 | - |
| Week 80: Non-Class Switched Memory B-Cells | 7.2 | - |
| Week 0: Total B-Cell Population | 71.7 | - |
| Week 54: Total B-Cell Population | 71.3 | - |
| Week 80: Total B-Cell Population | 70.3 | - |
| Week 0: Transitional B-Cells | 9.9 | - |
| Week 54: Transitional B-Cells | 10.7 | - |
| Week 80: Transitional B-Cells | 10.5 | - |
| Liraglutide (Experimental)Week 0: Activated Memory B-Cells | 1.6 | - |
| Week 54: Activated Memory B-Cells | 1.5 | - |
| Week 80: Activated Memory B-Cells | 1.5 | - |
| Week 0: Mature Naive B-Cells | 13.6 | - |
| Week 54: Mature Naive B-Cells | 13.6 | - |
| Week 80: Mature Naive B-Cells | 12.0 | - |
| Week 0: Antibody-Secreting Cells | 0.6 | - |
| Week 54: Antibody-Secreting Cells | 0.5 | - |
| Week 80: Antibody-Secreting Cells | 0.4 | - |
| Week 0: B-Cells Positive For Both CD19 & CD20 | 72.1 | - |
| Week 54: B-Cells Positive For Both CD19 & CD20 | 72.1 | - |
| Week 80: B-Cells Positive For Both CD19 & CD20 | 72.8 | - |
| Week 0: CD20Neg B-Cell | 0.6 | - |
| Week 54: CD20Neg B-Cell | 0.5 | - |
| Week 80: CD20Neg B-Cell | 0.6 | - |
| Week 0: CD24- B-Cells | 31.5 | - |
| Week 54: CD24- B-Cells | 31.3 | - |
| Week 80: CD24- B-Cells | 33.4 | - |
| Week 0: Class-Switched Memory B Cells | 4.8 | - |
| Week 54: Class-Switched Memory B Cells | 4.6 | - |
| Week 80: Class-Switched Memory B Cells | 4.6 | - |
| Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 0: Non-Class Switched Memory B-Cells | 9.6 | - |
| Week 54: Non-Class Switched Memory B-Cells | 8.7 | - |
| Week 80: Non-Class Switched Memory B-Cells | 8.0 | - |
| Week 0: Total B-Cell Population | 72.7 | - |
| Week 54: Total B-Cell Population | 72.6 | - |
| Week 80: Total B-Cell Population | 73.5 | - |
| Week 0: Transitional B-Cells | 9.5 | - |
| Week 54: Transitional B-Cells | 9.5 | - |
| Week 80: Transitional B-Cells | 8.1 | - |
| Placebo (Placebo)Week 0: Activated Memory B-Cells | 1.5 | - |
| Week 54: Activated Memory B-Cells | 1.3 | - |
| Week 80: Activated Memory B-Cells | 1.5 | - |
| Week 0: Mature Naive B-Cells | 13.3 | - |
| Week 54: Mature Naive B-Cells | 13.5 | - |
| Week 80: Mature Naive B-Cells | 12.8 | - |
| Week 0: Antibody-Secreting Cells | 0.6 | - |
| Week 54: Antibody-Secreting Cells | 0.6 | - |
| Week 80: Antibody-Secreting Cells | 0.6 | - |
| Week 0: B-Cells Positive For Both CD19 & CD20 | 72.2 | - |
| Week 54: B-Cells Positive For Both CD19 & CD20 | 65.9 | - |
| Week 80: B-Cells Positive For Both CD19 & CD20 | 69.6 | - |
| Week 0: CD20Neg B-Cell | 0.6 | - |
| Week 54: CD20Neg B-Cell | 0.6 | - |
| Week 80: CD20Neg B-Cell | 0.7 | - |
| Week 0: CD24- B-Cells | 32.0 | - |
| Week 54: CD24- B-Cells | 28.3 | - |
| Week 80: CD24- B-Cells | 30.7 | - |
| Week 0: Class-Switched Memory B Cells | 4.9 | - |
| Week 54: Class-Switched Memory B Cells | 4.8 | - |
| Week 80: Class-Switched Memory B Cells | 4.5 | - |
| Week 0: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 54: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 80: IgMNeg IgDNeg Switched Memory B-cells | 0.1 | - |
| Week 0: Non-Class Switched Memory B-Cells | 10.1 | - |
| Week 54: Non-Class Switched Memory B-Cells | 8.9 | - |
| Week 80: Non-Class Switched Memory B-Cells | 8.9 | - |
| Week 0: Total B-Cell Population | 72.8 | - |
| Week 54: Total B-Cell Population | 66.5 | - |
| Week 80: Total B-Cell Population | 70.4 | - |
| Week 0: Transitional B-Cells | 9.6 | - |
| Week 54: Transitional B-Cells | 9.8 | - |
| Week 80: Transitional B-Cells | 8.9 | - |
Secondary/registry result
Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · Percentage of NK cells (%) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: ADCC-Competent NK | 39.5 | - |
| Week 54: ADCC-Competent NK | 37.1 | - |
| Week 80: ADCC-Competent NK | 37.1 | - |
| Week 0: CD16+ Highly Functional NK Cells | 0.8 | - |
| Week 54: CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 80: CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 0: CD56- Cells | 34.5 | - |
| Week 54: CD56- Cells | 34.8 | - |
| Week 80: CD56- Cells | 36.2 | - |
| Week 0: CD56High NK Pool | 4.9 | - |
| Week 54: CD56High NK Pool | 4.9 | - |
| Week 80: CD56High NK Pool | 4.5 | - |
| Week 0: CD57+ MatNK Effectors | 22.6 | - |
| Week 54: CD57+ MatNK Effectors | 21.0 | - |
| Week 80: CD57+ MatNK Effectors | 20.0 | - |
| Week 0: Functional NK Cells; Efficient At ADCC | 14.5 | - |
| Week 54: Functional NK Cells; Efficient At ADCC | 13.2 | - |
| Week 80: Functional NK Cells; Efficient At ADCC | 13.3 | - |
| Week 0: Highly Cytolytic Subset Of NK Cells | 18.8 | - |
| Week 54: Highly Cytolytic Subset Of NK Cells | 22.2 | - |
| Week 80: Highly Cytolytic Subset Of NK Cells | 21.1 | - |
| Week 0: Mature CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 80: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 0: Mature CD16+ Terminally Differentiated | 1.3 | - |
| Week 54: Mature CD16+ Terminally Differentiated | 0.9 | - |
| Week 80: Mature CD16+ Terminally Differentiated | 1.1 | - |
| Week 0: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 54: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 80: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 0: Mature Cytolytic NK Cells | 2.3 | - |
| Week 54: Mature Cytolytic NK Cells | 2.4 | - |
| Week 80: Mature Cytolytic NK Cells | 2.3 | - |
| Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.6 | - |
| Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.6 | - |
| Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.2 | - |
| Week 0: Rapid Cytokine-Producing NK Cell Subset | 4.1 | - |
| Week 54: Rapid Cytokine-Producing NK Cell Subset | 4.2 | - |
| Week 80: Rapid Cytokine-Producing NK Cell Subset | 3.8 | - |
| Week 0: Senescent CD16+ CD56- NK cells | 1.3 | - |
| Week 54: Senescent CD16+ CD56- NK cells | 1.0 | - |
| Week 80: Senescent CD16+ CD56- NK cells | 1.1 | - |
| Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 54: Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 80: Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 0: Senescent CD16- CD56- NK cells | 1.3 | - |
| Week 54: Senescent CD16- CD56- NK cells | 1.5 | - |
| Week 80: Senescent CD16- CD56- NK cells | 1.9 | - |
| Week 0: Senescent Cytolytic NK Cells | 8.7 | - |
| Week 54: Senescent Cytolytic NK Cells | 9.9 | - |
| Week 80: Senescent Cytolytic NK Cells | 9.4 | - |
| Week 0: Senescent Rapid Cytokine-Producing NK | 0.1 | - |
| Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 0: Total CD16+ CD56- NK | 6.7 | - |
| Week 54: Total CD16+ CD56- NK | 5.9 | - |
| Week 80: Total CD16+ CD56- NK | 6.8 | - |
| Week 0: Total CD16- CD56- NK | 27.6 | - |
| Week 54: Week 0: Total CD16- CD56- NK | 28.6 | - |
| Week 80: Week 0: Total CD16- CD56- NK | 29.2 | - |
| Week 0: Total Mature NK Cells; Highly Cytolytic | 58.6 | - |
| Week 54: Total Mature NK Cells; Highly Cytolytic | 59.6 | - |
| Week 80: Total Mature NK Cells; Highly Cytolytic | 58.5 | - |
| NNC0114-0006 (Experimental)Week 0: ADCC-Competent NK | 36.3 | - |
| Week 54: ADCC-Competent NK | 32.5 | - |
| Week 80: ADCC-Competent NK | 33.2 | - |
| Week 0: CD16+ Highly Functional NK Cells | 0.8 | - |
| Week 54: CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 80: CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 0: CD56- Cells | 36.8 | - |
| Week 54: CD56- Cells | 36.6 | - |
| Week 80: CD56- Cells | 37.6 | - |
| Week 0: CD56High NK Pool | 5.1 | - |
| Week 54: CD56High NK Pool | 5.3 | - |
| Week 80: CD56High NK Pool | 5.1 | - |
| Week 0: CD57+ MatNK Effectors | 20.4 | - |
| Week 54: CD57+ MatNK Effectors | 18.0 | - |
| Week 80: CD57+ MatNK Effectors | 18.3 | - |
| Week 0: Functional NK Cells; Efficient At ADCC | 13.3 | - |
| Week 54: Functional NK Cells; Efficient At ADCC | 11.1 | - |
| Week 80: Functional NK Cells; Efficient At ADCC | 11.3 | - |
| Week 0: Highly Cytolytic Subset Of NK Cells | 20.9 | - |
| Week 54: Highly Cytolytic Subset Of NK Cells | 24.5 | - |
| Week 80: Highly Cytolytic Subset Of NK Cells | 23.0 | - |
| Week 0: Mature CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 80: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 0: Mature CD16+ Terminally Differentiated | 1.1 | - |
| Week 54: Mature CD16+ Terminally Differentiated | 0.8 | - |
| Week 80: Mature CD16+ Terminally Differentiated | 1.0 | - |
| Week 0: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 54: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 80: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 0: Mature Cytolytic NK Cells | 2.2 | - |
| Week 54: Mature Cytolytic NK Cells | 2.7 | - |
| Week 80: Mature Cytolytic NK Cells | 2.9 | - |
| Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.8 | - |
| Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.9 | - |
| Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.7 | - |
| Week 0: Rapid Cytokine-Producing NK Cell Subset | 4.4 | - |
| Week 54: Rapid Cytokine-Producing NK Cell Subset | 4.5 | - |
| Week 80: Rapid Cytokine-Producing NK Cell Subset | 4.4 | - |
| Week 0: Senescent CD16+ CD56- NK cells | 1.2 | - |
| Week 54: Senescent CD16+ CD56- NK cells | 1.2 | - |
| Week 80: Senescent CD16+ CD56- NK cells | 1.4 | - |
| Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 54: Week 0: Senescent CD16+CD56hi NK | 0.0 | - |
| Week 80: Week 0: Senescent CD16+CD56hi NK | 0.0 | - |
| Week 0: Senescent CD16- CD56- NK cells | 1.5 | - |
| Week 54: Senescent CD16- CD56- NK cells | 1.8 | - |
| Week 80: Senescent CD16- CD56- NK cells | 2.4 | - |
| Week 0: Senescent Cytolytic NK Cells | 9.9 | - |
| Week 54: Senescent Cytolytic NK Cells | 11.3 | - |
| Week 80: Senescent Cytolytic NK Cells | 11.1 | - |
| Week 0: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 0: Total CD16+ CD56- NK | 7.4 | - |
| Week 54: Total CD16+ CD56- NK | 6.2 | - |
| Week 80: Total CD16+ CD56- NK | 6.6 | - |
| Week 0: Total CD16- CD56- NK | 29.2 | - |
| Week 54: Week 0: Total CD16- CD56- NK | 30.1 | - |
| Week 80: Week 0: Total CD16- CD56- NK | 30.7 | - |
| Week 0: Total Mature NK Cells; Highly Cytolytic | 57.4 | - |
| Week 54: Total Mature NK Cells; Highly Cytolytic | 57.3 | - |
| Week 80: Total Mature NK Cells; Highly Cytolytic | 56.5 | - |
| Liraglutide (Experimental)Week 0: ADCC-Competent NK | 36.0 | - |
| Week 54: ADCC-Competent NK | 33.9 | - |
| Week 80: ADCC-Competent NK | 31.9 | - |
| Week 0: CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 54: CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 80: CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 0: CD56- Cells | 38.0 | - |
| Week 54: CD56- Cells | 38.1 | - |
| Week 80: CD56- Cells | 37.1 | - |
| Week 0: CD56High NK Pool | 4.5 | - |
| Week 54: CD56High NK Pool | 4.2 | - |
| Week 80: CD56High NK Pool | 4.3 | - |
| Week 0: CD57+ MatNK Effectors | 21.0 | - |
| Week 54: CD57+ MatNK Effectors | 18.9 | - |
| Week 80: CD57+ MatNK Effectors | 17.5 | - |
| Week 0: Functional NK Cells; Efficient At ADCC | 13.1 | - |
| Week 54: Functional NK Cells; Efficient At ADCC | 12.1 | - |
| Week 80: Functional NK Cells; Efficient At ADCC | 10.9 | - |
| Week 0: Highly Cytolytic Subset Of NK Cells | 20.6 | - |
| Week 54: Highly Cytolytic Subset Of NK Cells | 22.8 | - |
| Week 80: Highly Cytolytic Subset Of NK Cells | 25.5 | - |
| Week 0: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 80: Mature CD16+ Highly Functional NK Cells | 0.5 | - |
| Week 0: Mature CD16+ Terminally Differentiated | 1.1 | - |
| Week 54: Mature CD16+ Terminally Differentiated | 1.0 | - |
| Week 80: Mature CD16+ Terminally Differentiated | 0.8 | - |
| Week 0: Mature CD16- Terminally Differentiate NK | 0.4 | - |
| Week 54: Mature CD16- Terminally Differentiate NK | 0.3 | - |
| Week 80: Mature CD16- Terminally Differentiate NK | 0.4 | - |
| Week 0: Mature Cytolytic NK Cells | 2.4 | - |
| Week 54: Mature Cytolytic NK Cells | 2.5 | - |
| Week 80: Mature Cytolytic NK Cells | 2.6 | - |
| Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.3 | - |
| Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.0 | - |
| Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.0 | - |
| Week 0: Rapid Cytokine-Producing NK Cell Subset | 3.8 | - |
| Week 54: Rapid Cytokine-Producing NK Cell Subset | 3.5 | - |
| Week 80: Rapid Cytokine-Producing NK Cell Subset | 3.7 | - |
| Week 0: Senescent CD16+ CD56- NK cells | 1.0 | - |
| Week 54: Senescent CD16+ CD56- NK cells | 0.9 | - |
| Week 80: Senescent CD16+ CD56- NK cells | 0.9 | - |
| Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 54: Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 80: Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 0: Senescent CD16- CD56- NK cells | 1.3 | - |
| Week 54: Senescent CD16- CD56- NK cells | 1.6 | - |
| Week 80: Senescent CD16- CD56- NK cells | 1.9 | - |
| Week 0: Senescent Cytolytic NK Cells | 9.8 | - |
| Week 54: Senescent Cytolytic NK Cells | 10.9 | - |
| Week 80: Senescent Cytolytic NK Cells | 11.5 | - |
| Week 0: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 0: Total CD16+ CD56- NK | 6.4 | - |
| Week 54: Total CD16+ CD56- NK | 6.0 | - |
| Week 80: Total CD16+ CD56- NK | 6.2 | - |
| Week 0: Total CD16- CD56- NK | 31.4 | - |
| Week 54: Week 0: Total CD16- CD56- NK | 31.9 | - |
| Week 80: Week 0: Total CD16- CD56- NK | 30.7 | - |
| Week 0: Total Mature NK Cells; Highly Cytolytic | 56.8 | - |
| Week 54: Total Mature NK Cells; Highly Cytolytic | 56.9 | - |
| Week 80: Total Mature NK Cells; Highly Cytolytic | 57.7 | - |
| Placebo (Placebo)Week 0: ADCC-Competent NK | 34.7 | - |
| Week 54: ADCC-Competent NK | 31.5 | - |
| Week 80: ADCC-Competent NK | 34.1 | - |
| Week 0: CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 54: CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 80: CD16+ Highly Functional NK Cells | 0.8 | - |
| Week 0: CD56- Cells | 38.0 | - |
| Week 54: CD56- Cells | 41.1 | - |
| Week 80: CD56- Cells | 37.6 | - |
| Week 0: CD56High NK Pool | 4.9 | - |
| Week 54: CD56High NK Pool | 4.4 | - |
| Week 80: CD56High NK Pool | 5.4 | - |
| Week 0: CD57+ MatNK Effectors | 19.0 | - |
| Week 54: CD57+ MatNK Effectors | 16.6 | - |
| Week 80: CD57+ MatNK Effectors | 17.3 | - |
| Week 0: Functional NK Cells; Efficient At ADCC | 12.1 | - |
| Week 54: Functional NK Cells; Efficient At ADCC | 11.0 | - |
| Week 80: Functional NK Cells; Efficient At ADCC | 12.6 | - |
| Week 0: Highly Cytolytic Subset Of NK Cells | 21.4 | - |
| Week 54: Highly Cytolytic Subset Of NK Cells | 22.1 | - |
| Week 80: Highly Cytolytic Subset Of NK Cells | 21.9 | - |
| Week 0: Mature CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 54: Mature CD16+ Highly Functional NK Cells | 0.6 | - |
| Week 80: Mature CD16+ Highly Functional NK Cells | 0.7 | - |
| Week 0: Mature CD16+ Terminally Differentiated | 1.3 | - |
| Week 54: Mature CD16+ Terminally Differentiated | 1.1 | - |
| Week 80: Mature CD16+ Terminally Differentiated | 1.3 | - |
| Week 0: Mature CD16- Terminally Differentiate NK | 0.4 | - |
| Week 54: Mature CD16- Terminally Differentiate NK | 0.4 | - |
| Week 80: Mature CD16- Terminally Differentiate NK | 1.0 | - |
| Week 0: Mature Cytolytic NK Cells | 2.3 | - |
| Week 54: Mature Cytolytic NK Cells | 2.4 | - |
| Week 80: Mature Cytolytic NK Cells | 2.5 | - |
| Week 0: Mature Rapid Cytokine-Producing NK Cell | 3.6 | - |
| Week 54: Mature Rapid Cytokine-Producing NK Cell | 3.3 | - |
| Week 80: Mature Rapid Cytokine-Producing NK Cell | 3.9 | - |
| Week 0: Rapid Cytokine-Producing NK Cell Subset | 4.1 | - |
| Week 54: Rapid Cytokine-Producing NK Cell Subset | 3.8 | - |
| Week 80: Rapid Cytokine-Producing NK Cell Subset | 4.6 | - |
| Week 0: Senescent CD16+ CD56- NK cells | 1.2 | - |
| Week 54: Senescent CD16+ CD56- NK cells | 1.1 | - |
| Week 80: Senescent CD16+ CD56- NK cells | 1.2 | - |
| Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 54: Week 0: Senescent CD16+CD56hi NK | 0.0 | - |
| Week 80: Week 0: Senescent CD16+CD56hi NK | 0.1 | - |
| Week 0: Senescent CD16- CD56- NK cells | 1.5 | - |
| Week 54: Senescent CD16- CD56- NK cells | 2.0 | - |
| Week 80: Senescent CD16- CD56- NK cells | 2.2 | - |
| Week 0: Senescent Cytolytic NK Cells | 9.9 | - |
| Week 54: Senescent Cytolytic NK Cells | 9.6 | - |
| Week 80: Senescent Cytolytic NK Cells | 9.8 | - |
| Week 0: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 54: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 80: Senescent Rapid Cytokine-Producing NK | 0.0 | - |
| Week 0: Total CD16+ CD56- NK | 7.3 | - |
| Week 54: Total CD16+ CD56- NK | 6.8 | - |
| Week 80: Total CD16+ CD56- NK | 7.3 | - |
| Week 0: Total CD16- CD56- NK | 30.5 | - |
| Week 54: Week 0: Total CD16- CD56- NK | 34.0 | - |
| Week 80: Week 0: Total CD16- CD56- NK | 30.0 | - |
| Week 0: Total Mature NK Cells; Highly Cytolytic | 56.3 | - |
| Week 54: Total Mature NK Cells; Highly Cytolytic | 53.7 | - |
| Week 80: Total Mature NK Cells; Highly Cytolytic | 56.2 | - |
Secondary/registry result
Change in Biomarker: Immune Phenotyping- T Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · Percentage of T cells (%) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Activated CD4 TEMRA | 10.1 | - |
| Week 54: Activated CD4 TEMRA | 10.3 | - |
| Week 80: Activated CD4 TEMRA | 9.1 | - |
| Week 0: Activated CD8 TEMRA | 0.9 | - |
| Week 54: Activated CD8 TEMRA | 0.9 | - |
| Week 80: Activated CD8 TEMRA | 0.7 | - |
| Week 0: Activated Central Memory CD4 | 6.3 | - |
| Week 54: Activated Central Memory CD4 | 6.3 | - |
| Week 80: Activated Central Memory CD4 | 6.5 | - |
| Week 0: Activated Central Memory CD8 | 1.1 | - |
| Week 54: Activated Central Memory CD8 | 1.4 | - |
| Week 80: Activated Central Memory CD8 | 2.2 | - |
| Week 0: Activated Effector Memory CD4 | 10.3 | - |
| Week 54: Activated Effector Memory CD4 | 10.1 | - |
| Week 80: Activated Effector Memory CD4 | 10.2 | - |
| Week 0: Activated Effector Memory CD8 | 1.9 | - |
| Week 54: Activated Effector Memory CD8 | 2.0 | - |
| Week 80: Activated Effector Memory CD8 | 1.9 | - |
| Week 0: Activated Mature Naive CD4 T-Cells | 4.0 | - |
| Week 54: Activated Mature Naive CD4 T-Cells | 3.9 | - |
| Week 80: Activated Mature Naive CD4 T-Cells | 4.0 | - |
| Week 0: Activated Mature Naive CD8 T-Cells | 3.4 | - |
| Week 54: Activated Mature Naive CD8 T-Cells | 3.0 | - |
| Week 80: Activated Mature Naive CD8 T-Cells | 2.7 | - |
| Week 0: CCR5+ CD4 TEMRA | 17.7 | - |
| Week 54: CCR5+ CD4 TEMRA | 18.4 | - |
| Week 80: CCR5+ CD4 TEMRA | 18.3 | - |
| Week 0: CCR5+ CD4 Treg TEMRA | 3.7 | - |
| Week 54: CCR5+ CD4 Treg TEMRA | 4.2 | - |
| Week 80: CCR5+ CD4 Treg TEMRA | 2.8 | - |
| Week 0: CCR5+ CD8 EM | 35.3 | - |
| Week 54: CCR5+ CD8 EM | 37.9 | - |
| Week 80: CCR5+ CD8 EM | 38.8 | - |
| Week 0: CCR5+ CD8 TEMRA | 22.8 | - |
| Week 54: CCR5+ CD8 TEMRA | 25.9 | - |
| Week 80: CCR5+ CD8 TEMRA | 25.9 | - |
| Week 0: CCR5+ Central Memory CD4 Cells | 4.1 | - |
| Week 54: CCR5+ Central Memory CD4 Cells | 4.5 | - |
| Week 80: CCR5+ Central Memory CD4 Cells | 4.9 | - |
| Week 0: CCR5+ Central Memory CD8 Cells | 15.0 | - |
| Week 54: CCR5+ Central Memory CD8 Cells | 16.8 | - |
| Week 80: CCR5+ Central Memory CD8 Cells | 16.8 | - |
| Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.9 | - |
| Week 54: CCR5+ Central Memory Regulatory T-Cells | 2.0 | - |
| Week 80: CCR5+ Central Memory Regulatory T-Cells | 2.1 | - |
| Week 0: CCR5+ Effector Memory CD4 | 15.5 | - |
| Week 54: CCR5+ Effector Memory CD4 | 16.2 | - |
| Week 80: CCR5+ Effector Memory CD4 | 17.5 | - |
| Week 0: CCR5+ Effector Memory Regulatory T-Cells | 4.7 | - |
| Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.8 | - |
| Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.2 | - |
| Week 0: CCR5+ Naive CD4 T-Cells | 1.9 | - |
| Week 54: CCR5+ Naive CD4 T-Cells | 2.0 | - |
| Week 80: CCR5+ Naive CD4 T-Cells | 2.3 | - |
| Week 0: CCR5+ Naive CD8 T-Cells | 3.7 | - |
| Week 54: CCR5+ Naive CD8 T-Cells | 3.4 | - |
| Week 80: CCR5+ Naive CD8 T-Cells | 3.8 | - |
| Week 0: CCR5+ Naive Regulatory T-Cells | 6.1 | - |
| Week 54: CCR5+ Naive Regulatory T-Cells | 6.7 | - |
| Week 80: CCR5+ Naive Regulatory T-Cells | 5.8 | - |
| Week 0: CD4 TEMRA | 3.7 | - |
| Week 54: CD4 TEMRA | 3.8 | - |
| Week 80: CD4 TEMRA | 4.4 | - |
| Week 0: CD8 Central Memory | 2.0 | - |
| Week 54: CD8 Central Memory | 1.8 | - |
| Week 80: CD8 Central Memory | 1.8 | - |
| Week 0: CD8 Effector Memory | 14.3 | - |
| Week 54: CD8 Effector Memory | 15.1 | - |
| Week 80: CD8 Effector Memory | 15.1 | - |
| Week 0: CD8 TEMRA | 31.6 | - |
| Week 54: CD8 TEMRA | 29.8 | - |
| Week 80: CD8 TEMRA | 31.9 | - |
| Week 0: Conventional Central Memory CD4 T-Cells | 20.0 | - |
| Week 54: Conventional Central Memory CD4 T-Cells | 20.4 | - |
| Week 80: Conventional Central Memory CD4 T-Cells | 19.4 | - |
| Week 0: Conventional Effector Memory CD4 T-Cells | 19.2 | - |
| Week 54: Conventional Effector Memory CD4 T-Cells | 20.3 | - |
| Week 80: Conventional Effector Memory CD4 T-Cells | 20.0 | - |
| Week 0: Naive CD4 T-Cells | 57.0 | - |
| Week 54: Naive CD4 T-Cells | 55.4 | - |
| Week 80: Naive CD4 T-Cells | 56.1 | - |
| Week 0: Naive CD8 T-Cells | 52.0 | - |
| Week 54: Naive CD8 T-Cells | 53.2 | - |
| Week 80: Naive CD8 T-Cells | 51.1 | - |
| Week 0: Senescent CD4 Central Memory Cells | 2.3 | - |
| Week 54: Senescent CD4 Central Memory Cells | 1.9 | - |
| Week 80: Senescent CD4 Central Memory Cells | 2.3 | - |
| Week 0: Senescent CD4 Effector Memory Cells | 6.9 | - |
| Week 54: Senescent CD4 Effector Memory Cells | 5.9 | - |
| Week 80: Senescent CD4 Effector Memory Cells | 6.9 | - |
| Week 0: Senescent CD8 Central Memory Cells | 12.1 | - |
| Week 54: Senescent CD8 Central Memory Cells | 11.7 | - |
| Week 80: Senescent CD8 Central Memory Cells | 12.7 | - |
| Week 0: Senescent CD8 Effector Memory Cells | 27.3 | - |
| Week 54: Senescent CD8 Effector Memory Cells | 25.2 | - |
| Week 80: Senescent CD8 Effector Memory Cells | 27.5 | - |
| Week 0: Senescent Naive CD4 T-Cells | 2.6 | - |
| Week 54: Senescent Naive CD4 T-Cells | 2.5 | - |
| Week 80: Senescent Naive CD4 T-Cells | 3.1 | - |
| Week 0: Senescent Naive CD8 T-Cells | 3.9 | - |
| Week 54: Senescent Naive CD8 T-Cells | 3.5 | - |
| Week 80: Senescent Naive CD8 T-Cells | 4.4 | - |
| Week 0: Senescent Naive TREG | 6.9 | - |
| Week 54: Senescent Naive TREG | 7.2 | - |
| Week 80: Senescent Naive TREG | 6.3 | - |
| Week 0: Senescent TEMRA CD4 | 23.3 | - |
| Week 54: Senescent TEMRA CD4 | 20.0 | - |
| Week 80: Senescent TEMRA CD4 | 21.0 | - |
| Week 0: Senescent TEMRA CD8 | 42.8 | - |
| Week 54: Senescent TEMRA CD8 | 39.2 | - |
| Week 80: Senescent TEMRA CD8 | 42.7 | - |
| Week 0: Senescent TEMRA TREG | 3.6 | - |
| Week 54: Senescent TEMRA TREG | 3.9 | - |
| Week 80: Senescent TEMRA TREG | 2.6 | - |
| Week 0: Senescent TREG CM | 0.1 | - |
| Week 54: Senescent TREG CM | 0.1 | - |
| Week 80: Senescent TREG CM | 0.2 | - |
| Week 0: Senescent TREG EM | 0.4 | - |
| Week 54: Senescent TREG EM | 0.4 | - |
| Week 80: Senescent TREG EM | 0.5 | - |
| Week 0: Total Naive TREG | 46.8 | - |
| Week 54: Total Naive TREG | 43.7 | - |
| Week 80: Total Naive TREG | 46.8 | - |
| Week 0: Total TREG | 3.9 | - |
| Week 54: Total TREG | 3.8 | - |
| Week 80: Total TREG | 3.7 | - |
| Week 0: Total TREG CM | 14.8 | - |
| Week 54: Total TREG CM | 15.5 | - |
| Week 80: Total TREG CM | 15.3 | - |
| Week 0: Total TREG EM | 30.8 | - |
| Week 54: Total TREG EM | 32.4 | - |
| Week 80: Total TREG EM | 30.7 | - |
| Week 0: Total TREG TEMRA | 7.6 | - |
| Week 54: Total TREG TEMRA | 8.5 | - |
| Week 80: Total TREG TEMRA | 7.3 | - |
| Week 0: Total Viable CD4 T-Cells | 54.7 | - |
| Week 54: Total Viable CD4 T-Cells | 54.3 | - |
| Week 80: Total Viable CD4 T-Cells | 51.9 | - |
| Week 0: Total Viable CD8 T-Cells | 26.1 | - |
| Week 54: Total Viable CD8 T-Cells | 25.0 | - |
| Week 80: Total Viable CD8 T-Cells | 24.2 | - |
| Week 0: Total Viable T-Cells | 55.6 | - |
| Week 54: Total Viable T-Cells | 53.6 | - |
| Week 80: Total Viable T-Cells | 52.7 | - |
| NNC0114-0006 (Experimental)Week 0: Activated CD4 TEMRA | 9.7 | - |
| Week 54: Activated CD4 TEMRA | 8.7 | - |
| Week 80: Activated CD4 TEMRA | 8.1 | - |
| Week 0: Activated CD8 TEMRA | 0.8 | - |
| Week 54: Activated CD8 TEMRA | 0.6 | - |
| Week 80: Activated CD8 TEMRA | 0.6 | - |
| Week 0: Activated Central Memory CD4 | 6.7 | - |
| Week 54: Activated Central Memory CD4 | 6.1 | - |
| Week 80: Activated Central Memory CD4 | 6.0 | - |
| Week 0: Activated Central Memory CD8 | 1.7 | - |
| Week 54: Activated Central Memory CD8 | 1.6 | - |
| Week 80: Activated Central Memory CD8 | 1.4 | - |
| Week 0: Activated Effector Memory CD4 | 10.9 | - |
| Week 54: Activated Effector Memory CD4 | 9.6 | - |
| Week 80: Activated Effector Memory CD4 | 8.9 | - |
| Week 0: Activated Effector Memory CD8 | 1.7 | - |
| Week 54: Activated Effector Memory CD8 | 1.6 | - |
| Week 80: Activated Effector Memory CD8 | 1.5 | - |
| Week 0: Activated Mature Naive CD4 T-Cells | 4.0 | - |
| Week 54: Activated Mature Naive CD4 T-Cells | 3.8 | - |
| Week 80: Activated Mature Naive CD4 T-Cells | 3.8 | - |
| Week 0: Activated Mature Naive CD8 T-Cells | 2.8 | - |
| Week 54: Activated Mature Naive CD8 T-Cells | 2.6 | - |
| Week 80: Activated Mature Naive CD8 T-Cells | 2.6 | - |
| Week 0: CCR5+ CD4 TEMRA | 16.4 | - |
| Week 54: CCR5+ CD4 TEMRA | 17.7 | - |
| Week 80: CCR5+ CD4 TEMRA | 19.5 | - |
| Week 0: CCR5+ CD4 Treg TEMRA | 1.7 | - |
| Week 54: CCR5+ CD4 Treg TEMRA | 4.2 | - |
| Week 80: CCR5+ CD4 Treg TEMRA | 4.4 | - |
| Week 0: CCR5+ CD8 EM | 35.5 | - |
| Week 54: CCR5+ CD8 EM | 36.4 | - |
| Week 80: CCR5+ CD8 EM | 34.7 | - |
| Week 0: CCR5+ CD8 TEMRA | 22.9 | - |
| Week 54: CCR5+ CD8 TEMRA | 25.0 | - |
| Week 80: CCR5+ CD8 TEMRA | 24.4 | - |
| Week 0: CCR5+ Central Memory CD4 Cells | 4.3 | - |
| Week 54: CCR5+ Central Memory CD4 Cells | 4.1 | - |
| Week 80: CCR5+ Central Memory CD4 Cells | 4.9 | - |
| Week 0: CCR5+ Central Memory CD8 Cells | 14.4 | - |
| Week 54: CCR5+ Central Memory CD8 Cells | 14.2 | - |
| Week 80: CCR5+ Central Memory CD8 Cells | 15.5 | - |
| Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.8 | - |
| Week 54: CCR5+ Central Memory Regulatory T-Cells | 1.5 | - |
| Week 80: CCR5+ Central Memory Regulatory T-Cells | 1.8 | - |
| Week 0: CCR5+ Effector Memory CD4 | 14.5 | - |
| Week 54: CCR5+ Effector Memory CD4 | 15.7 | - |
| Week 80: CCR5+ Effector Memory CD4 | 16.8 | - |
| Week 0: CCR5+ Effector Memory Regulatory T-Cells | 5.1 | - |
| Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.6 | - |
| Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.2 | - |
| Week 0: CCR5+ Naive CD4 T-Cells | 2.0 | - |
| Week 54: CCR5+ Naive CD4 T-Cells | 2.1 | - |
| Week 80: CCR5+ Naive CD4 T-Cells | 2.9 | - |
| Week 0: CCR5+ Naive CD8 T-Cells | 3.5 | - |
| Week 54: CCR5+ Naive CD8 T-Cells | 3.5 | - |
| Week 80: CCR5+ Naive CD8 T-Cells | 4.0 | - |
| Week 0: CCR5+ Naive Regulatory T-Cells | 5.0 | - |
| Week 54: CCR5+ Naive Regulatory T-Cells | 6.3 | - |
| Week 80: CCR5+ Naive Regulatory T-Cells | 6.5 | - |
| Week 0: CD4 TEMRA | 2.6 | - |
| Week 54: CD4 TEMRA | 2.9 | - |
| Week 80: CD4 TEMRA | 3.2 | - |
| Week 0: CD8 Central Memory | 2.0 | - |
| Week 54: CD8 Central Memory | 2.1 | - |
| Week 80: CD8 Central Memory | 1.9 | - |
| Week 0: CD8 Effector Memory | 14.7 | - |
| Week 54: CD8 Effector Memory | 14.8 | - |
| Week 80: CD8 Effector Memory | 16.5 | - |
| Week 0: CD8 TEMRA | 30.9 | - |
| Week 54: CD8 TEMRA | 31.0 | - |
| Week 80: CD8 TEMRA | 33.5 | - |
| Week 0: Conventional Central Memory CD4 T-Cells | 22.1 | - |
| Week 54: Conventional Central Memory CD4 T-Cells | 22.2 | - |
| Week 80: Conventional Central Memory CD4 T-Cells | 21.7 | - |
| Week 0: Conventional Effector Memory CD4 T-Cells | 22.8 | - |
| Week 54: Conventional Effector Memory CD4 T-Cells | 22.9 | - |
| Week 80: Conventional Effector Memory CD4 T-Cells | 24.4 | - |
| Week 0: Naive CD4 T-Cells | 52.4 | - |
| Week 54: Naive CD4 T-Cells | 51.8 | - |
| Week 80: Naive CD4 T-Cells | 50.6 | - |
| Week 0: Naive CD8 T-Cells | 52.5 | - |
| Week 54: Naive CD8 T-Cells | 52.1 | - |
| Week 80: Naive CD8 T-Cells | 48.1 | - |
| Week 0: Senescent CD4 Central Memory Cells | 2.2 | - |
| Week 54: Senescent CD4 Central Memory Cells | 2.1 | - |
| Week 80: Senescent CD4 Central Memory Cells | 2.3 | - |
| Week 0: Senescent CD4 Effector Memory Cells | 6.3 | - |
| Week 54: Senescent CD4 Effector Memory Cells | 6.7 | - |
| Week 80: Senescent CD4 Effector Memory Cells | 7.0 | - |
| Week 0: Senescent CD8 Central Memory Cells | 11.5 | - |
| Week 54: Senescent CD8 Central Memory Cells | 10.4 | - |
| Week 80: Senescent CD8 Central Memory Cells | 12.7 | - |
| Week 0: Senescent CD8 Effector Memory Cells | 27.2 | - |
| Week 54: Senescent CD8 Effector Memory Cells | 25.1 | - |
| Week 80: Senescent CD8 Effector Memory Cells | 28.6 | - |
| Week 0: Senescent Naive CD4 T-Cells | 2.9 | - |
| Week 54: Senescent Naive CD4 T-Cells | 3.0 | - |
| Week 80: Senescent Naive CD4 T-Cells | 3.3 | - |
| Week 0: Senescent Naive CD8 T-Cells | 3.6 | - |
| Week 54: Senescent Naive CD8 T-Cells | 3.8 | - |
| Week 80: Senescent Naive CD8 T-Cells | 4.3 | - |
| Week 0: Senescent Naive TREG | 5.5 | - |
| Week 54: Senescent Naive TREG | 6.8 | - |
| Week 80: Senescent Naive TREG | 7.0 | - |
| Week 0: Senescent TEMRA CD4 | 21.7 | - |
| Week 54: Senescent TEMRA CD4 | 22.8 | - |
| Week 80: Senescent TEMRA CD4 | 24.2 | - |
| Week 0: Senescent TEMRA CD8 | 40.3 | - |
| Week 54: Senescent TEMRA CD8 | 40.7 | - |
| Week 80: Senescent TEMRA CD8 | 44.8 | - |
| Week 0: Senescent TEMRA TREG | 1.8 | - |
| Week 54: Senescent TEMRA TREG | 4.2 | - |
| Week 80: Senescent TEMRA TREG | 4.4 | - |
| Week 0: Senescent TREG CM | 0.1 | - |
| Week 54: Senescent TREG CM | 0.1 | - |
| Week 80: Senescent TREG CM | 0.2 | - |
| Week 0: Senescent TREG EM | 0.4 | - |
| Week 54: Senescent TREG EM | 0.3 | - |
| Week 80: Senescent TREG EM | 0.5 | - |
| Week 0: Total Naive TREG | 42.4 | - |
| Week 54: Total Naive TREG | 44.3 | - |
| Week 80: Total Naive TREG | 44.1 | - |
| Week 0: Total TREG | 3.8 | - |
| Week 54: Total TREG | 3.5 | - |
| Week 80: Total TREG | 3.5 | - |
| Week 0: Total TREG CM | 15.8 | - |
| Week 54: Total TREG CM | 15.6 | - |
| Week 80: Total TREG CM | 15.0 | - |
| Week 0: Total TREG EM | 36.4 | - |
| Week 54: Total TREG EM | 32.6 | - |
| Week 80: Total TREG EM | 33.5 | - |
| Week 0: Total TREG TEMRA | 5.5 | - |
| Week 54: Total TREG TEMRA | 7.7 | - |
| Week 80: Total TREG TEMRA | 7.4 | - |
| Week 0: Total Viable CD4 T-Cells | 53.2 | - |
| Week 54: Total Viable CD4 T-Cells | 52.1 | - |
| Week 80: Total Viable CD4 T-Cells | 50.3 | - |
| Week 0: Total Viable CD8 T-Cells | 28.2 | - |
| Week 54: Total Viable CD8 T-Cells | 26.7 | - |
| Week 80: Total Viable CD8 T-Cells | 25.4 | - |
| Week 0: Total Viable T-Cells | 55.2 | - |
| Week 54: Total Viable T-Cells | 55.9 | - |
| Week 80: Total Viable T-Cells | 55.3 | - |
| Liraglutide (Experimental)Week 0: Activated CD4 TEMRA | 10.8 | - |
| Week 54: Activated CD4 TEMRA | 9.7 | - |
| Week 80: Activated CD4 TEMRA | 8.1 | - |
| Week 0: Activated CD8 TEMRA | 0.6 | - |
| Week 54: Activated CD8 TEMRA | 0.6 | - |
| Week 80: Activated CD8 TEMRA | 0.6 | - |
| Week 0: Activated Central Memory CD4 | 7.1 | - |
| Week 54: Activated Central Memory CD4 | 6.3 | - |
| Week 80: Activated Central Memory CD4 | 6.0 | - |
| Week 0: Activated Central Memory CD8 | 1.6 | - |
| Week 54: Activated Central Memory CD8 | 1.5 | - |
| Week 80: Activated Central Memory CD8 | 1.6 | - |
| Week 0: Activated Effector Memory CD4 | 11.3 | - |
| Week 54: Activated Effector Memory CD4 | 10.0 | - |
| Week 80: Activated Effector Memory CD4 | 9.5 | - |
| Week 0: Activated Effector Memory CD8 | 1.2 | - |
| Week 54: Activated Effector Memory CD8 | 1.2 | - |
| Week 80: Activated Effector Memory CD8 | 1.4 | - |
| Week 0: Activated Mature Naive CD4 T-Cells | 4.7 | - |
| Week 54: Activated Mature Naive CD4 T-Cells | 4.5 | - |
| Week 80: Activated Mature Naive CD4 T-Cells | 4.0 | - |
| Week 0: Activated Mature Naive CD8 T-Cells | 3.3 | - |
| Week 54: Activated Mature Naive CD8 T-Cells | 2.6 | - |
| Week 80: Activated Mature Naive CD8 T-Cells | 2.5 | - |
| Week 0: CCR5+ CD4 TEMRA | 16.9 | - |
| Week 54: CCR5+ CD4 TEMRA | 18.8 | - |
| Week 80: CCR5+ CD4 TEMRA | 18.6 | - |
| Week 0: CCR5+ CD4 Treg TEMRA | 2.7 | - |
| Week 54: CCR5+ CD4 Treg TEMRA | 4.6 | - |
| Week 80: CCR5+ CD4 Treg TEMRA | 3.2 | - |
| Week 0: CCR5+ CD8 EM | 38.2 | - |
| Week 54: CCR5+ CD8 EM | 38.0 | - |
| Week 80: CCR5+ CD8 EM | 37.5 | - |
| Week 0: CCR5+ CD8 TEMRA | 25.9 | - |
| Week 54: CCR5+ CD8 TEMRA | 26.3 | - |
| Week 80: CCR5+ CD8 TEMRA | 26.8 | - |
| Week 0: CCR5+ Central Memory CD4 Cells | 4.5 | - |
| Week 54: CCR5+ Central Memory CD4 Cells | 4.1 | - |
| Week 80: CCR5+ Central Memory CD4 Cells | 5.1 | - |
| Week 0: CCR5+ Central Memory CD8 Cells | 16.9 | - |
| Week 54: CCR5+ Central Memory CD8 Cells | 15.8 | - |
| Week 80: CCR5+ Central Memory CD8 Cells | 15.8 | - |
| Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.8 | - |
| Week 54: CCR5+ Central Memory Regulatory T-Cells | 1.7 | - |
| Week 80: CCR5+ Central Memory Regulatory T-Cells | 1.9 | - |
| Week 0: CCR5+ Effector Memory CD4 | 15.5 | - |
| Week 54: CCR5+ Effector Memory CD4 | 14.9 | - |
| Week 80: CCR5+ Effector Memory CD4 | 16.4 | - |
| Week 0: CCR5+ Effector Memory Regulatory T-Cells | 4.5 | - |
| Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.4 | - |
| Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.4 | - |
| Week 0: CCR5+ Naive CD4 T-Cells | 2.1 | - |
| Week 54: CCR5+ Naive CD4 T-Cells | 2.1 | - |
| Week 80: CCR5+ Naive CD4 T-Cells | 2.8 | - |
| Week 0: CCR5+ Naive CD8 T-Cells | 4.1 | - |
| Week 54: CCR5+ Naive CD8 T-Cells | 3.5 | - |
| Week 80: CCR5+ Naive CD8 T-Cells | 4.3 | - |
| Week 0: CCR5+ Naive Regulatory T-Cells | 6.5 | - |
| Week 54: CCR5+ Naive Regulatory T-Cells | 4.8 | - |
| Week 80: CCR5+ Naive Regulatory T-Cells | 5.7 | - |
| Week 0: CD4 TEMRA | 3.1 | - |
| Week 54: CD4 TEMRA | 3.3 | - |
| Week 80: CD4 TEMRA | 3.6 | - |
| Week 0: CD8 Central Memory | 1.8 | - |
| Week 54: CD8 Central Memory | 1.7 | - |
| Week 80: CD8 Central Memory | 1.8 | - |
| Week 0: CD8 Effector Memory | 13.4 | - |
| Week 54: CD8 Effector Memory | 11.3 | - |
| Week 80: CD8 Effector Memory | 13.9 | - |
| Week 0: CD8 TEMRA | 29.0 | - |
| Week 54: CD8 TEMRA | 30.3 | - |
| Week 80: CD8 TEMRA | 30.4 | - |
| Week 0: Conventional Central Memory CD4 T-Cells | 20.3 | - |
| Week 54: Conventional Central Memory CD4 T-Cells | 19.9 | - |
| Week 80: Conventional Central Memory CD4 T-Cells | 19.9 | - |
| Week 0: Conventional Effector Memory CD4 T-Cells | 19.5 | - |
| Week 54: Conventional Effector Memory CD4 T-Cells | 20.5 | - |
| Week 80: Conventional Effector Memory CD4 T-Cells | 20.9 | - |
| Week 0: Naive CD4 T-Cells | 57.0 | - |
| Week 54: Naive CD4 T-Cells | 56.3 | - |
| Week 80: Naive CD4 T-Cells | 55.6 | - |
| Week 0: Naive CD8 T-Cells | 55.8 | - |
| Week 54: Naive CD8 T-Cells | 54.7 | - |
| Week 80: Naive CD8 T-Cells | 53.9 | - |
| Week 0: Senescent CD4 Central Memory Cells | 2.4 | - |
| Week 54: Senescent CD4 Central Memory Cells | 2.2 | - |
| Week 80: Senescent CD4 Central Memory Cells | 2.1 | - |
| Week 0: Senescent CD4 Effector Memory Cells | 6.9 | - |
| Week 54: Senescent CD4 Effector Memory Cells | 6.6 | - |
| Week 80: Senescent CD4 Effector Memory Cells | 6.4 | - |
| Week 0: Senescent CD8 Central Memory Cells | 12.9 | - |
| Week 54: Senescent CD8 Central Memory Cells | 12.0 | - |
| Week 80: Senescent CD8 Central Memory Cells | 11.3 | - |
| Week 0: Senescent CD8 Effector Memory Cells | 27.7 | - |
| Week 54: Senescent CD8 Effector Memory Cells | 26.1 | - |
| Week 80: Senescent CD8 Effector Memory Cells | 26.5 | - |
| Week 0: Senescent Naive CD4 T-Cells | 2.6 | - |
| Week 54: Senescent Naive CD4 T-Cells | 2.8 | - |
| Week 80: Senescent Naive CD4 T-Cells | 3.1 | - |
| Week 0: Senescent Naive CD8 T-Cells | 3.5 | - |
| Week 54: Senescent Naive CD8 T-Cells | 3.7 | - |
| Week 80: Senescent Naive CD8 T-Cells | 3.8 | - |
| Week 0: Senescent Naive TREG | 7.1 | - |
| Week 54: Senescent Naive TREG | 5.0 | - |
| Week 80: Senescent Naive TREG | 6.0 | - |
| Week 0: Senescent TEMRA CD4 | 21.9 | - |
| Week 54: Senescent TEMRA CD4 | 23.1 | - |
| Week 80: Senescent TEMRA CD4 | 21.7 | - |
| Week 0: Senescent TEMRA CD8 | 37.7 | - |
| Week 54: Senescent TEMRA CD8 | 38.3 | - |
| Week 80: Senescent TEMRA CD8 | 38.7 | - |
| Week 0: Senescent TEMRA TREG | 2.8 | - |
| Week 54: Senescent TEMRA TREG | 4.6 | - |
| Week 80: Senescent TEMRA TREG | 3.2 | - |
| Week 0: Senescent TREG CM | 0.1 | - |
| Week 54: Senescent TREG CM | 0.1 | - |
| Week 80: Senescent TREG CM | 0.1 | - |
| Week 0: Senescent TREG EM | 0.4 | - |
| Week 54: Senescent TREG EM | 0.3 | - |
| Week 80: Senescent TREG EM | 0.5 | - |
| Week 0: Total Naive TREG | 50.3 | - |
| Week 54: Total Naive TREG | 49.4 | - |
| Week 80: Total Naive TREG | 48.7 | - |
| Week 0: Total TREG | 4.1 | - |
| Week 54: Total TREG | 4.0 | - |
| Week 80: Total TREG | 3.4 | - |
| Week 0: Total TREG CM | 14.4 | - |
| Week 54: Total TREG CM | 13.8 | - |
| Week 80: Total TREG CM | 13.8 | - |
| Week 0: Total TREG EM | 28.8 | - |
| Week 54: Total TREG EM | 28.3 | - |
| Week 80: Total TREG EM | 30.2 | - |
| Week 0: Total TREG TEMRA | 6.7 | - |
| Week 54: Total TREG TEMRA | 8.6 | - |
| Week 80: Total TREG TEMRA | 7.5 | - |
| Week 0: Total Viable CD4 T-Cells | 54.6 | - |
| Week 54: Total Viable CD4 T-Cells | 54.6 | - |
| Week 80: Total Viable CD4 T-Cells | 53.1 | - |
| Week 0: Total Viable CD8 T-Cells | 25.8 | - |
| Week 54: Total Viable CD8 T-Cells | 24.6 | - |
| Week 80: Total Viable CD8 T-Cells | 23.5 | - |
| Week 0: Total Viable T-Cells | 55.3 | - |
| Week 54: Total Viable T-Cells | 57.4 | - |
| Week 80: Total Viable T-Cells | 56.2 | - |
| Placebo (Placebo)Week 0: Activated CD4 TEMRA | 9.7 | - |
| Week 54: Activated CD4 TEMRA | 9.3 | - |
| Week 80: Activated CD4 TEMRA | 8.7 | - |
| Week 0: Activated CD8 TEMRA | 1.0 | - |
| Week 54: Activated CD8 TEMRA | 0.7 | - |
| Week 80: Activated CD8 TEMRA | 1.1 | - |
| Week 0: Activated Central Memory CD4 | 6.1 | - |
| Week 54: Activated Central Memory CD4 | 6.2 | - |
| Week 80: Activated Central Memory CD4 | 6.5 | - |
| Week 0: Activated Central Memory CD8 | 1.1 | - |
| Week 54: Activated Central Memory CD8 | 3.1 | - |
| Week 80: Activated Central Memory CD8 | 1.9 | - |
| Week 0: Activated Effector Memory CD4 | 9.4 | - |
| Week 54: Activated Effector Memory CD4 | 9.2 | - |
| Week 80: Activated Effector Memory CD4 | 9.1 | - |
| Week 0: Activated Effector Memory CD8 | 0.9 | - |
| Week 54: Activated Effector Memory CD8 | 1.1 | - |
| Week 80: Activated Effector Memory CD8 | 1.1 | - |
| Week 0: Activated Mature Naive CD4 T-Cells | 3.9 | - |
| Week 54: Activated Mature Naive CD4 T-Cells | 3.7 | - |
| Week 80: Activated Mature Naive CD4 T-Cells | 3.9 | - |
| Week 0: Activated Mature Naive CD8 T-Cells | 3.5 | - |
| Week 54: Activated Mature Naive CD8 T-Cells | 3.1 | - |
| Week 80: Activated Mature Naive CD8 T-Cells | 3.1 | - |
| Week 0: CCR5+ CD4 TEMRA | 18.9 | - |
| Week 54: CCR5+ CD4 TEMRA | 21.0 | - |
| Week 80: CCR5+ CD4 TEMRA | 21.4 | - |
| Week 0: CCR5+ CD4 Treg TEMRA | 3.9 | - |
| Week 54: CCR5+ CD4 Treg TEMRA | 4.6 | - |
| Week 80: CCR5+ CD4 Treg TEMRA | 4.4 | - |
| Week 0: CCR5+ CD8 EM | 37.7 | - |
| Week 54: CCR5+ CD8 EM | 38.8 | - |
| Week 80: CCR5+ CD8 EM | 40.0 | - |
| Week 0: CCR5+ CD8 TEMRA | 24.3 | - |
| Week 54: CCR5+ CD8 TEMRA | 25.4 | - |
| Week 80: CCR5+ CD8 TEMRA | 26.9 | - |
| Week 0: CCR5+ Central Memory CD4 Cells | 4.5 | - |
| Week 54: CCR5+ Central Memory CD4 Cells | 4.9 | - |
| Week 80: CCR5+ Central Memory CD4 Cells | 5.7 | - |
| Week 0: CCR5+ Central Memory CD8 Cells | 16.7 | - |
| Week 54: CCR5+ Central Memory CD8 Cells | 18.5 | - |
| Week 80: CCR5+ Central Memory CD8 Cells | 19.3 | - |
| Week 0: CCR5+ Central Memory Regulatory T-Cells | 1.5 | - |
| Week 54: CCR5+ Central Memory Regulatory T-Cells | 1.7 | - |
| Week 80: CCR5+ Central Memory Regulatory T-Cells | 2.2 | - |
| Week 0: CCR5+ Effector Memory CD4 | 15.3 | - |
| Week 54: CCR5+ Effector Memory CD4 | 16.9 | - |
| Week 80: CCR5+ Effector Memory CD4 | 18.4 | - |
| Week 0: CCR5+ Effector Memory Regulatory T-Cells | 4.1 | - |
| Week 54: CCR5+ Effector Memory Regulatory T-Cells | 4.5 | - |
| Week 80: CCR5+ Effector Memory Regulatory T-Cells | 5.2 | - |
| Week 0: CCR5+ Naive CD4 T-Cells | 2.0 | - |
| Week 54: CCR5+ Naive CD4 T-Cells | 2.3 | - |
| Week 80: CCR5+ Naive CD4 T-Cells | 3.5 | - |
| Week 0: CCR5+ Naive CD8 T-Cells | 4.2 | - |
| Week 54: CCR5+ Naive CD8 T-Cells | 4.1 | - |
| Week 80: CCR5+ Naive CD8 T-Cells | 4.9 | - |
| Week 0: CCR5+ Naive Regulatory T-Cells | 6.5 | - |
| Week 54: CCR5+ Naive Regulatory T-Cells | 5.3 | - |
| Week 80: CCR5+ Naive Regulatory T-Cells | 7.1 | - |
| Week 0: CD4 TEMRA | 2.7 | - |
| Week 54: CD4 TEMRA | 3.1 | - |
| Week 80: CD4 TEMRA | 3.5 | - |
| Week 0: CD8 Central Memory | 1.9 | - |
| Week 54: CD8 Central Memory | 2.1 | - |
| Week 80: CD8 Central Memory | 2.2 | - |
| Week 0: CD8 Effector Memory | 15.7 | - |
| Week 54: CD8 Effector Memory | 16.4 | - |
| Week 80: CD8 Effector Memory | 17.4 | - |
| Week 0: CD8 TEMRA | 32.3 | - |
| Week 54: CD8 TEMRA | 30.4 | - |
| Week 80: CD8 TEMRA | 33.4 | - |
| Week 0: Conventional Central Memory CD4 T-Cells | 21.6 | - |
| Week 54: Conventional Central Memory CD4 T-Cells | 21.1 | - |
| Week 80: Conventional Central Memory CD4 T-Cells | 21.1 | - |
| Week 0: Conventional Effector Memory CD4 T-Cells | 20.7 | - |
| Week 54: Conventional Effector Memory CD4 T-Cells | 21.3 | - |
| Week 80: Conventional Effector Memory CD4 T-Cells | 23.2 | - |
| Week 0: Naive CD4 T-Cells | 54.9 | - |
| Week 54: Naive CD4 T-Cells | 54.5 | - |
| Week 80: Naive CD4 T-Cells | 52.1 | - |
| Week 0: Naive CD8 T-Cells | 50.1 | - |
| Week 54: Naive CD8 T-Cells | 51.1 | - |
| Week 80: Naive CD8 T-Cells | 46.9 | - |
| Week 0: Senescent CD4 Central Memory Cells | 2.3 | - |
| Week 54: Senescent CD4 Central Memory Cells | 2.4 | - |
| Week 80: Senescent CD4 Central Memory Cells | 2.6 | - |
| Week 0: Senescent CD4 Effector Memory Cells | 6.7 | - |
| Week 54: Senescent CD4 Effector Memory Cells | 7.5 | - |
| Week 80: Senescent CD4 Effector Memory Cells | 7.6 | - |
| Week 0: Senescent CD8 Central Memory Cells | 12.4 | - |
| Week 54: Senescent CD8 Central Memory Cells | 12.2 | - |
| Week 80: Senescent CD8 Central Memory Cells | 12.2 | - |
| Week 0: Senescent CD8 Effector Memory Cells | 29.1 | - |
| Week 54: Senescent CD8 Effector Memory Cells | 25.8 | - |
| Week 80: Senescent CD8 Effector Memory Cells | 26.6 | - |
| Week 0: Senescent Naive CD4 T-Cells | 2.5 | - |
| Week 54: Senescent Naive CD4 T-Cells | 2.7 | - |
| Week 80: Senescent Naive CD4 T-Cells | 3.9 | - |
| Week 0: Senescent Naive CD8 T-Cells | 4.2 | - |
| Week 54: Senescent Naive CD8 T-Cells | 4.2 | - |
| Week 80: Senescent Naive CD8 T-Cells | 4.5 | - |
| Week 0: Senescent Naive TREG | 7.3 | - |
| Week 54: Senescent Naive TREG | 5.6 | - |
| Week 80: Senescent Naive TREG | 7.4 | - |
| Week 0: Senescent TEMRA CD4 | 22.0 | - |
| Week 54: Senescent TEMRA CD4 | 23.5 | - |
| Week 80: Senescent TEMRA CD4 | 25.4 | - |
| Week 0: Senescent TEMRA CD8 | 42.0 | - |
| Week 54: Senescent TEMRA CD8 | 40.4 | - |
| Week 80: Senescent TEMRA CD8 | 43.5 | - |
| Week 0: Senescent TEMRA TREG | 4.0 | - |
| Week 54: Senescent TEMRA TREG | 4.6 | - |
| Week 80: Senescent TEMRA TREG | 4.4 | - |
| Week 0: Senescent TREG CM | 0.2 | - |
| Week 54: Senescent TREG CM | 0.2 | - |
| Week 80: Senescent TREG CM | 0.3 | - |
| Week 0: Senescent TREG EM | 0.4 | - |
| Week 54: Senescent TREG EM | 0.5 | - |
| Week 80: Senescent TREG EM | 0.5 | - |
| Week 0: Total Naive TREG | 47.7 | - |
| Week 54: Total Naive TREG | 45.1 | - |
| Week 80: Total Naive TREG | 43.4 | - |
| Week 0: Total TREG | 3.5 | - |
| Week 54: Total TREG | 3.5 | - |
| Week 80: Total TREG | 3.4 | - |
| Week 0: Total TREG CM | 14.2 | - |
| Week 54: Total TREG CM | 15.0 | - |
| Week 80: Total TREG CM | 15.9 | - |
| Week 0: Total TREG EM | 30.7 | - |
| Week 54: Total TREG EM | 31.9 | - |
| Week 80: Total TREG EM | 32.9 | - |
| Week 0: Total TREG TEMRA | 7.5 | - |
| Week 54: Total TREG TEMRA | 8.2 | - |
| Week 80: Total TREG TEMRA | 7.8 | - |
| Week 0: Total Viable CD4 T-Cells | 54.6 | - |
| Week 54: Total Viable CD4 T-Cells | 52.7 | - |
| Week 80: Total Viable CD4 T-Cells | 52.2 | - |
| Week 0: Total Viable CD8 T-Cells | 26.6 | - |
| Week 54: Total Viable CD8 T-Cells | 24.0 | - |
| Week 80: Total Viable CD8 T-Cells | 23.9 | - |
| Week 0: Total Viable T-Cells | 55.0 | - |
| Week 54: Total Viable T-Cells | 55.5 | - |
| Week 80: Total Viable T-Cells | 55.8 | - |
Secondary/registry result
Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · Percentage of TfH cells (%) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Activated cTfh17 Cells | 0.8 | - |
| Week 54: Activated cTfh17 Cells | 0.6 | - |
| Week 80: Activated cTfh17 Cells | 0.8 | - |
| Week 0: Activated cTfh2 Cells | 0.6 | - |
| Week 54: Activated cTfh2 Cells | 0.4 | - |
| Week 80: Activated cTfh2 Cells | 0.6 | - |
| Week 0:Activated PD1+ICOS+ cTfh1 | 1.3 | - |
| Week 54: Activated PD1+ICOS+ cTfh1 | 0.7 | - |
| Week 80: Activated PD1+ICOS+ cTfh1 | 0.7 | - |
| Week 0: CCR7+ cTfh1 Cells | 96.9 | - |
| Week 54: CCR7+ cTfh1 Cells | 97.1 | - |
| Week 80: CCR7+ cTfh1 Cells | 97.0 | - |
| Week 0: CCR7+ cTfh17 Cells | 97.4 | - |
| Week 54: CCR7+ cTfh17 Cells | 98.1 | - |
| Week 80: CCR7+ cTfh17 Cells | 98.7 | - |
| Week 0: CCR7+ cTfh2 Cells | 98.1 | - |
| Week 54: CCR7+ cTfh2 Cells | 98.1 | - |
| Week 80: CCR7+ cTfh2 Cells | 98.3 | - |
| Week 0: CXCR4+ cTfh1 Cells | 59.4 | - |
| Week 54: CXCR4+ cTfh1 Cells | 64.5 | - |
| Week 80: CXCR4+ cTfh1 Cells | 70.8 | - |
| Week 0: CXCR4+ cTfh17 Cells | 50.9 | - |
| Week 54: CXCR4+ cTfh17 Cells | 56.1 | - |
| Week 80: CXCR4+ cTfh17 Cells | 60.0 | - |
| Week 0: CXCR4+ Ctfh2 Cells | 58.8 | - |
| Week 54: CXCR4+ Ctfh2 Cells | 63.3 | - |
| Week 80: CXCR4+ Ctfh2 Cells | 69.3 | - |
| Week 0: Circulating TFH-Cells (cTfh) | 5.5 | - |
| Week 54: Circulating TFH-Cells (cTfh) | 5.7 | - |
| Week 80: Circulating TFH-Cells (cTfh) | 5.8 | - |
| Week 0: ICOS+ CD4 CM | 0.5 | - |
| Week 54: ICOS+ CD4 CM | 0.3 | - |
| Week 80: ICOS+ CD4 CM | 0.3 | - |
| Week 0: ICOS+ CD4 EM | 0.2 | - |
| Week 54: ICOS+ CD4 EM | 0.2 | - |
| Week 80: ICOS+ CD4 EM | 0.2 | - |
| Week 0: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 54: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 80: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 | - |
| Week 54: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 0: ICOS+ NAIVE TREG | 2.3 | - |
| Week 54: ICOS+ NAIVE TREG | 2.1 | - |
| Week 80: ICOS+ NAIVE TREG | 2.2 | - |
| Week 0: ICOS+ TREG CM | 10.9 | - |
| Week 54: ICOS+ TREG CM | 10.0 | - |
| Week 80: ICOS+ TREG CM | 10.1 | - |
| Week 0: ICOS+ TREG EM | 12.8 | - |
| Week 54: ICOS+ TREG EM | 11.9 | - |
| Week 80: ICOS+ TREG EM | 12.0 | - |
| Week 0: ICOS+ TREG TEMRA | 10.2 | - |
| Week 54: ICOS+ TREG TEMRA | 8.8 | - |
| Week 80: ICOS+ TREG TEMRA | 9.9 | - |
| Week 0: PD1+ CD4 Central Memory | 6.2 | - |
| Week 54: PD1+ CD4 Central Memory | 6.4 | - |
| Week 80: PD1+ CD4 Central Memory | 6.7 | - |
| Week 0: PD1+ CD4 Effector Memory | 4.0 | - |
| Week 54: PD1+ CD4 Effector Memory | 3.7 | - |
| Week 80: PD1+ CD4 Effector Memory | 3.9 | - |
| Week 0: PD1+ Naive CD4 | 3.8 | - |
| Week 54: PD1+ Naive CD4 | 4.2 | - |
| Week 80: PD1+ Naive CD4 | 5.0 | - |
| Week 0: PD1+ Naive TREG | 8.4 | - |
| Week 54: PD1+ Naive TREG | 9.8 | - |
| Week 80: PD1+ Naive TREG | 11.0 | - |
| Week 0: PD1+ TEMRA TREG | 22.5 | - |
| Week 54: PD1+ TEMRA TREG | 20.5 | - |
| Week 80: PD1+ TEMRA TREG | 22.5 | - |
| Week 0: PD1+ TREG CM | 16.8 | - |
| Week 54: PD1+ TREG CM | 16.5 | - |
| Week 80: PD1+ TREG CM | 18.1 | - |
| Week 0: PD1+ TREG EM | 20.1 | - |
| Week 54: PD1+ TREG EM | 19.3 | - |
| Week 80: PD1+ TREG EM | 20.6 | - |
| Week 0: PD1+ICOSNeg cTfh1 | 30.0 | - |
| Week 54: PD1+ICOSNeg cTfh1 | 30.5 | - |
| Week 80: PD1+ICOSNeg cTfh1 | 32.4 | - |
| Week 0: PD1+ICOSNeg cTfh17 | 21.8 | - |
| Week 54: PD1+ICOSNeg cTfh17 | 21.8 | - |
| Week 80: PD1+ICOSNeg cTfh17 | 26.8 | - |
| Week 0: PD1+ICOSNeg cTfh2 | 19.1 | - |
| Week 54: PD1+ICOSNeg cTfh2 | 18.4 | - |
| Week 80: PD1+ICOSNeg cTfh2 | 20.2 | - |
| Week 0: PD1- ICOS- cTfh1 | 68.4 | - |
| Week 54: PD1- ICOS- cTfh1 | 68.6 | - |
| Week 80: PD1- ICOS- cTfh1 | 66.7 | - |
| Week 0: PD1- ICOS- cTfh17 | 75.6 | - |
| Week 54: PD1- ICOS- cTfh17 | 77.4 | - |
| Week 80: PD1- ICOS- cTfh17 | 72.1 | - |
| Week 0: PD1- ICOS- cTfh2 | 80.1 | - |
| Week 54: PD1- ICOS- cTfh2 | 81.0 | - |
| Week 80: PD1- ICOS- cTfh2 | 79.1 | - |
| Week 0: Potentially Anergic TEMRA CD4 | 0.7 | - |
| Week 54: Potentially Anergic TEMRA CD4 | 0.8 | - |
| Week 80: Potentially Anergic TEMRA CD4 | 0.8 | - |
| Week 0: Regulatory T-Follicular Subset | 0.2 | - |
| Week 54: Regulatory T-Follicular Subset | 0.2 | - |
| Week 80: Regulatory T-Follicular Subset | 0.2 | - |
| Week 0: TH17-Like Circulating T-Follicular cells | 0.5 | - |
| Week 54: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 80: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 0: TH2-Like Circulating T-Follicular Cells | 3.6 | - |
| Week 54: TH2-Like Circulating T-Follicular Cells | 3.9 | - |
| Week 80: TH2-Like Circulating T-Follicular Cells | 3.8 | - |
| Week 0: TIGIT+ cTfh1 | 53.0 | - |
| Week 54: TIGIT+ cTfh1 | 51.1 | - |
| Week 80: TIGIT+ cTfh1 | 51.4 | - |
| Week 0: TIGIT+ cTfh17 | 40.5 | - |
| Week 54: TIGIT+ cTfh17 | 37.0 | - |
| Week 80: TIGIT+ cTfh17 | 39.4 | - |
| Week 0: TIGIT+ cTfh2 | 44.4 | - |
| Week 54: TIGIT+ cTfh2 | 41.1 | - |
| Week 80: TIGIT+ cTfh2 | 40.7 | - |
| Week 0: TOTAL ICOS+ TREG | 8.6 | - |
| Week 54: TOTAL ICOS+ TREG | 8.3 | - |
| Week 80: TOTAL ICOS+ TREG | 8.3 | - |
| Week 0: Th1-Like Circulating T-Follicular Cells | 1.3 | - |
| Week 54: Th1-Like Circulating T-Follicular Cells | 1.4 | - |
| Week 80: Th1-Like Circulating T-Follicular Cells | 1.5 | - |
| Week 0: Total PD1+ TREG | 14.5 | - |
| Week 54: Total PD1+ TREG | 14.8 | - |
| Week 80: Total PD1+ TREG | 16.0 | - |
| NNC0114-0006 (Experimental)Week 0: Activated cTfh17 Cells | 1.0 | - |
| Week 54: Activated cTfh17 Cells | 0.4 | - |
| Week 80: Activated cTfh17 Cells | 1.1 | - |
| Week 0: Activated cTfh2 Cells | 0.6 | - |
| Week 54: Activated cTfh2 Cells | 0.4 | - |
| Week 80: Activated cTfh2 Cells | 0.5 | - |
| Week 0:Activated PD1+ICOS+ cTfh1 | 1.9 | - |
| Week 54: Activated PD1+ICOS+ cTfh1 | 1.0 | - |
| Week 80: Activated PD1+ICOS+ cTfh1 | 0.9 | - |
| Week 0: CCR7+ cTfh1 Cells | 97.1 | - |
| Week 54: CCR7+ cTfh1 Cells | 95.8 | - |
| Week 80: CCR7+ cTfh1 Cells | 96.8 | - |
| Week 0: CCR7+ cTfh17 Cells | 97.4 | - |
| Week 54: CCR7+ cTfh17 Cells | 93.9 | - |
| Week 80: CCR7+ cTfh17 Cells | 97.3 | - |
| Week 0: CCR7+ cTfh2 Cells | 98.2 | - |
| Week 54: CCR7+ cTfh2 Cells | 98.5 | - |
| Week 80: CCR7+ cTfh2 Cells | 98.3 | - |
| Week 0: CXCR4+ cTfh1 Cells | 58.0 | - |
| Week 54: CXCR4+ cTfh1 Cells | 64.5 | - |
| Week 80: CXCR4+ cTfh1 Cells | 66.4 | - |
| Week 0: CXCR4+ cTfh17 Cells | 45.8 | - |
| Week 54: CXCR4+ cTfh17 Cells | 54.0 | - |
| Week 80: CXCR4+ cTfh17 Cells | 57.2 | - |
| Week 0: CXCR4+ Ctfh2 Cells | 56.3 | - |
| Week 54: CXCR4+ Ctfh2 Cells | 65.2 | - |
| Week 80: CXCR4+ Ctfh2 Cells | 65.8 | - |
| Week 0: Circulating TFH-Cells (cTfh) | 5.4 | - |
| Week 54: Circulating TFH-Cells (cTfh) | 5.6 | - |
| Week 80: Circulating TFH-Cells (cTfh) | 5.9 | - |
| Week 0: ICOS+ CD4 CM | 0.5 | - |
| Week 54: ICOS+ CD4 CM | 0.3 | - |
| Week 80: ICOS+ CD4 CM | 0.3 | - |
| Week 0: ICOS+ CD4 EM | 0.3 | - |
| Week 54: ICOS+ CD4 EM | 0.2 | - |
| Week 80: ICOS+ CD4 EM | 0.2 | - |
| Week 0: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 54: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 80: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 | - |
| Week 54: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 0: ICOS+ NAIVE TREG | 2.7 | - |
| Week 54: ICOS+ NAIVE TREG | 2.0 | - |
| Week 80: ICOS+ NAIVE TREG | 2.1 | - |
| Week 0: ICOS+ TREG CM | 11.3 | - |
| Week 54: ICOS+ TREG CM | 9.2 | - |
| Week 80: ICOS+ TREG CM | 9.0 | - |
| Week 0: ICOS+ TREG EM | 13.3 | - |
| Week 54: ICOS+ TREG EM | 11.6 | - |
| Week 80: ICOS+ TREG EM | 11.3 | - |
| Week 0: ICOS+ TREG TEMRA | 13.0 | - |
| Week 54: ICOS+ TREG TEMRA | 9.7 | - |
| Week 80: ICOS+ TREG TEMRA | 9.6 | - |
| Week 0: PD1+ CD4 Central Memory | 6.7 | - |
| Week 54: PD1+ CD4 Central Memory | 6.8 | - |
| Week 80: PD1+ CD4 Central Memory | 7.5 | - |
| Week 0: PD1+ CD4 Effector Memory | 4.2 | - |
| Week 54: PD1+ CD4 Effector Memory | 3.9 | - |
| Week 80: PD1+ CD4 Effector Memory | 4.3 | - |
| Week 0: PD1+ Naive CD4 | 3.0 | - |
| Week 54: PD1+ Naive CD4 | 2.9 | - |
| Week 80: PD1+ Naive CD4 | 3.3 | - |
| Week 0: PD1+ Naive TREG | 8.7 | - |
| Week 54: PD1+ Naive TREG | 9.4 | - |
| Week 80: PD1+ Naive TREG | 10.1 | - |
| Week 0: PD1+ TEMRA TREG | 23.5 | - |
| Week 54: PD1+ TEMRA TREG | 19.7 | - |
| Week 80: PD1+ TEMRA TREG | 25.7 | - |
| Week 0: PD1+ TREG CM | 17.5 | - |
| Week 54: PD1+ TREG CM | 16.7 | - |
| Week 80: PD1+ TREG CM | 18.7 | - |
| Week 0: PD1+ TREG EM | 21.1 | - |
| Week 54: PD1+ TREG EM | 19.8 | - |
| Week 80: PD1+ TREG EM | 21.1 | - |
| Week 0: PD1+ICOSNeg cTfh1 | 28.8 | - |
| Week 54: PD1+ICOSNeg cTfh1 | 29.1 | - |
| Week 80: PD1+ICOSNeg cTfh1 | 30.7 | - |
| Week 0: PD1+ICOSNeg cTfh17 | 22.5 | - |
| Week 54: PD1+ICOSNeg cTfh17 | 21.1 | - |
| Week 80: PD1+ICOSNeg cTfh17 | 24.7 | - |
| Week 0: PD1+ICOSNeg cTfh2 | 18.4 | - |
| Week 54: PD1+ICOSNeg cTfh2 | 18.1 | - |
| Week 80: PD1+ICOSNeg cTfh2 | 19.6 | - |
| Week 0: PD1- ICOS- cTfh1 | 69.0 | - |
| Week 54: PD1- ICOS- cTfh1 | 68.0 | - |
| Week 80: PD1- ICOS- cTfh1 | 68.1 | - |
| Week 0: PD1- ICOS- cTfh17 | 74.7 | - |
| Week 54: PD1- ICOS- cTfh17 | 72.9 | - |
| Week 80: PD1- ICOS- cTfh17 | 74.0 | - |
| Week 0: PD1- ICOS- cTfh2 | 80.8 | - |
| Week 54: PD1- ICOS- cTfh2 | 81.3 | - |
| Week 80: PD1- ICOS- cTfh2 | 79.8 | - |
| Week 0: Potentially Anergic TEMRA CD4 | 0.2 | - |
| Week 54: Potentially Anergic TEMRA CD4 | 0.2 | - |
| Week 80: Potentially Anergic TEMRA CD4 | 0.2 | - |
| Week 0: Regulatory T-Follicular Subset | 0.2 | - |
| Week 54: Regulatory T-Follicular Subset | 0.2 | - |
| Week 80: Regulatory T-Follicular Subset | 0.2 | - |
| Week 0: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 54: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 80: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 0: TH2-Like Circulating T-Follicular Cells | 3.6 | - |
| Week 54: TH2-Like Circulating T-Follicular Cells | 3.6 | - |
| Week 80: TH2-Like Circulating T-Follicular Cells | 3.7 | - |
| Week 0: TIGIT+ cTfh1 | 48.5 | - |
| Week 54: TIGIT+ cTfh1 | 47.6 | - |
| Week 80: TIGIT+ cTfh1 | 48.1 | - |
| Week 0: TIGIT+ cTfh17 | 36.2 | - |
| Week 54: TIGIT+ cTfh17 | 31.4 | - |
| Week 80: TIGIT+ cTfh17 | 35.9 | - |
| Week 0: TIGIT+ cTfh2 | 40.9 | - |
| Week 54: TIGIT+ cTfh2 | 37.9 | - |
| Week 80: TIGIT+ cTfh2 | 38.4 | - |
| Week 0: TOTAL ICOS+ TREG | 9.6 | - |
| Week 54: TOTAL ICOS+ TREG | 7.5 | - |
| Week 80: TOTAL ICOS+ TREG | 7.4 | - |
| Week 0: Th1-Like Circulating T-Follicular Cells | 1.3 | - |
| Week 54: Th1-Like Circulating T-Follicular Cells | 1.6 | - |
| Week 80: Th1-Like Circulating T-Follicular Cells | 1.8 | - |
| Week 0: Total PD1+ TREG | 15.1 | - |
| Week 54: Total PD1+ TREG | 14.3 | - |
| Week 80: Total PD1+ TREG | 15.9 | - |
| Liraglutide (Experimental)Week 0: Activated cTfh17 Cells | 0.8 | - |
| Week 54: Activated cTfh17 Cells | 0.7 | - |
| Week 80: Activated cTfh17 Cells | 0.6 | - |
| Week 0: Activated cTfh2 Cells | 0.6 | - |
| Week 54: Activated cTfh2 Cells | 0.7 | - |
| Week 80: Activated cTfh2 Cells | 0.5 | - |
| Week 0:Activated PD1+ICOS+ cTfh1 | 1.1 | - |
| Week 54: Activated PD1+ICOS+ cTfh1 | 1.2 | - |
| Week 80: Activated PD1+ICOS+ cTfh1 | 1.0 | - |
| Week 0: CCR7+ cTfh1 Cells | 94.7 | - |
| Week 54: CCR7+ cTfh1 Cells | 97.1 | - |
| Week 80: CCR7+ cTfh1 Cells | 97.4 | - |
| Week 0: CCR7+ cTfh17 Cells | 97.4 | - |
| Week 54: CCR7+ cTfh17 Cells | 96.9 | - |
| Week 80: CCR7+ cTfh17 Cells | 96.8 | - |
| Week 0: CCR7+ cTfh2 Cells | 98.2 | - |
| Week 54: CCR7+ cTfh2 Cells | 98.3 | - |
| Week 80: CCR7+ cTfh2 Cells | 98.4 | - |
| Week 0: CXCR4+ cTfh1 Cells | 54.9 | - |
| Week 54: CXCR4+ cTfh1 Cells | 64.4 | - |
| Week 80: CXCR4+ cTfh1 Cells | 63.5 | - |
| Week 0: CXCR4+ cTfh17 Cells | 43.7 | - |
| Week 54: CXCR4+ cTfh17 Cells | 53.1 | - |
| Week 80: CXCR4+ cTfh17 Cells | 54.6 | - |
| Week 0: CXCR4+ Ctfh2 Cells | 54.0 | - |
| Week 54: CXCR4+ Ctfh2 Cells | 63.7 | - |
| Week 80: CXCR4+ Ctfh2 Cells | 62.7 | - |
| Week 0: Circulating TFH-Cells (cTfh) | 6.2 | - |
| Week 54: Circulating TFH-Cells (cTfh) | 6.2 | - |
| Week 80: Circulating TFH-Cells (cTfh) | 6.1 | - |
| Week 0: ICOS+ CD4 CM | 0.4 | - |
| Week 54: ICOS+ CD4 CM | 0.4 | - |
| Week 80: ICOS+ CD4 CM | 0.3 | - |
| Week 0: ICOS+ CD4 EM | 0.2 | - |
| Week 54: ICOS+ CD4 EM | 0.2 | - |
| Week 80: ICOS+ CD4 EM | 0.2 | - |
| Week 0: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 54: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 80: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 | - |
| Week 54: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 0: ICOS+ NAIVE TREG | 1.9 | - |
| Week 54: ICOS+ NAIVE TREG | 1.9 | - |
| Week 80: ICOS+ NAIVE TREG | 1.9 | - |
| Week 0: ICOS+ TREG CM | 10.4 | - |
| Week 54: ICOS+ TREG CM | 9.7 | - |
| Week 80: ICOS+ TREG CM | 8.8 | - |
| Week 0: ICOS+ TREG EM | 13.0 | - |
| Week 54: ICOS+ TREG EM | 12.8 | - |
| Week 80: ICOS+ TREG EM | 10.5 | - |
| Week 0: ICOS+ TREG TEMRA | 10.5 | - |
| Week 54: ICOS+ TREG TEMRA | 11.0 | - |
| Week 80: ICOS+ TREG TEMRA | 8.2 | - |
| Week 0: PD1+ CD4 Central Memory | 7.2 | - |
| Week 54: PD1+ CD4 Central Memory | 7.2 | - |
| Week 80: PD1+ CD4 Central Memory | 6.8 | - |
| Week 0: PD1+ CD4 Effector Memory | 4.0 | - |
| Week 54: PD1+ CD4 Effector Memory | 3.6 | - |
| Week 80: PD1+ CD4 Effector Memory | 3.6 | - |
| Week 0: PD1+ Naive CD4 | 4.2 | - |
| Week 54: PD1+ Naive CD4 | 4.4 | - |
| Week 80: PD1+ Naive CD4 | 4.2 | - |
| Week 0: PD1+ Naive TREG | 8.4 | - |
| Week 54: PD1+ Naive TREG | 9.1 | - |
| Week 80: PD1+ Naive TREG | 9.3 | - |
| Week 0: PD1+ TEMRA TREG | 19.8 | - |
| Week 54: PD1+ TEMRA TREG | 18.6 | - |
| Week 80: PD1+ TEMRA TREG | 22.4 | - |
| Week 0: PD1+ TREG CM | 17.3 | - |
| Week 54: PD1+ TREG CM | 16.8 | - |
| Week 80: PD1+ TREG CM | 16.6 | - |
| Week 0: PD1+ TREG EM | 21.6 | - |
| Week 54: PD1+ TREG EM | 21.1 | - |
| Week 80: PD1+ TREG EM | 19.4 | - |
| Week 0: PD1+ICOSNeg cTfh1 | 32.4 | - |
| Week 54: PD1+ICOSNeg cTfh1 | 34.2 | - |
| Week 80: PD1+ICOSNeg cTfh1 | 31.3 | - |
| Week 0: PD1+ICOSNeg cTfh17 | 23.7 | - |
| Week 54: PD1+ICOSNeg cTfh17 | 26.2 | - |
| Week 80: PD1+ICOSNeg cTfh17 | 23.6 | - |
| Week 0: PD1+ICOSNeg cTfh2 | 20.8 | - |
| Week 54: PD1+ICOSNeg cTfh2 | 20.2 | - |
| Week 80: PD1+ICOSNeg cTfh2 | 18.9 | - |
| Week 0: PD1- ICOS- cTfh1 | 64.6 | - |
| Week 54: PD1- ICOS- cTfh1 | 64.1 | - |
| Week 80: PD1- ICOS- cTfh1 | 67.4 | - |
| Week 0: PD1- ICOS- cTfh17 | 73.4 | - |
| Week 54: PD1- ICOS- cTfh17 | 70.9 | - |
| Week 80: PD1- ICOS- cTfh17 | 73.6 | - |
| Week 0: PD1- ICOS- cTfh2 | 78.3 | - |
| Week 54: PD1- ICOS- cTfh2 | 78.8 | - |
| Week 80: PD1- ICOS- cTfh2 | 80.4 | - |
| Week 0: Potentially Anergic TEMRA CD4 | 0.4 | - |
| Week 54: Potentially Anergic TEMRA CD4 | 0.5 | - |
| Week 80: Potentially Anergic TEMRA CD4 | 0.5 | - |
| Week 0: Regulatory T-Follicular Subset | 0.2 | - |
| Week 54: Regulatory T-Follicular Subset | 0.2 | - |
| Week 80: Regulatory T-Follicular Subset | 0.2 | - |
| Week 0: TH17-Like Circulating T-Follicular cells | 0.5 | - |
| Week 54: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 80: TH17-Like Circulating T-Follicular cells | 0.3 | - |
| Week 0: TH2-Like Circulating T-Follicular Cells | 4.0 | - |
| Week 54: TH2-Like Circulating T-Follicular Cells | 4.0 | - |
| Week 80: TH2-Like Circulating T-Follicular Cells | 3.9 | - |
| Week 0: TIGIT+ cTfh1 | 53.4 | - |
| Week 54: TIGIT+ cTfh1 | 52.2 | - |
| Week 80: TIGIT+ cTfh1 | 49.6 | - |
| Week 0: TIGIT+ cTfh17 | 39.3 | - |
| Week 54: TIGIT+ cTfh17 | 40.7 | - |
| Week 80: TIGIT+ cTfh17 | 35.3 | - |
| Week 0: TIGIT+ cTfh2 | 44.8 | - |
| Week 54: TIGIT+ cTfh2 | 42.0 | - |
| Week 80: TIGIT+ cTfh2 | 40.5 | - |
| Week 0: TOTAL ICOS+ TREG | 8.0 | - |
| Week 54: TOTAL ICOS+ TREG | 7.6 | - |
| Week 80: TOTAL ICOS+ TREG | 6.6 | - |
| Week 0: Th1-Like Circulating T-Follicular Cells | 1.6 | - |
| Week 54: Th1-Like Circulating T-Follicular Cells | 1.8 | - |
| Week 80: Th1-Like Circulating T-Follicular Cells | 1.9 | - |
| Week 0: Total PD1+ TREG | 14.7 | - |
| Week 54: Total PD1+ TREG | 14.5 | - |
| Week 80: Total PD1+ TREG | 14.2 | - |
| Placebo (Placebo)Week 0: Activated cTfh17 Cells | 0.6 | - |
| Week 54: Activated cTfh17 Cells | 0.9 | - |
| Week 80: Activated cTfh17 Cells | 0.9 | - |
| Week 0: Activated cTfh2 Cells | 0.6 | - |
| Week 54: Activated cTfh2 Cells | 0.6 | - |
| Week 80: Activated cTfh2 Cells | 0.6 | - |
| Week 0:Activated PD1+ICOS+ cTfh1 | 1.0 | - |
| Week 54: Activated PD1+ICOS+ cTfh1 | 1.2 | - |
| Week 80: Activated PD1+ICOS+ cTfh1 | 1.1 | - |
| Week 0: CCR7+ cTfh1 Cells | 97.2 | - |
| Week 54: CCR7+ cTfh1 Cells | 97.3 | - |
| Week 80: CCR7+ cTfh1 Cells | 97.0 | - |
| Week 0: CCR7+ cTfh17 Cells | 97.3 | - |
| Week 54: CCR7+ cTfh17 Cells | 95.3 | - |
| Week 80: CCR7+ cTfh17 Cells | 98.7 | - |
| Week 0: CCR7+ cTfh2 Cells | 98.3 | - |
| Week 54: CCR7+ cTfh2 Cells | 98.1 | - |
| Week 80: CCR7+ cTfh2 Cells | 98.3 | - |
| Week 0: CXCR4+ cTfh1 Cells | 55.6 | - |
| Week 54: CXCR4+ cTfh1 Cells | 69.4 | - |
| Week 80: CXCR4+ cTfh1 Cells | 66.8 | - |
| Week 0: CXCR4+ cTfh17 Cells | 45.1 | - |
| Week 54: CXCR4+ cTfh17 Cells | 56.4 | - |
| Week 80: CXCR4+ cTfh17 Cells | 57.6 | - |
| Week 0: CXCR4+ Ctfh2 Cells | 54.5 | - |
| Week 54: CXCR4+ Ctfh2 Cells | 67.7 | - |
| Week 80: CXCR4+ Ctfh2 Cells | 66.7 | - |
| Week 0: Circulating TFH-Cells (cTfh) | 6.1 | - |
| Week 54: Circulating TFH-Cells (cTfh) | 6.2 | - |
| Week 80: Circulating TFH-Cells (cTfh) | 5.8 | - |
| Week 0: ICOS+ CD4 CM | 0.5 | - |
| Week 54: ICOS+ CD4 CM | 0.4 | - |
| Week 80: ICOS+ CD4 CM | 0.3 | - |
| Week 0: ICOS+ CD4 EM | 0.2 | - |
| Week 54: ICOS+ CD4 EM | 0.2 | - |
| Week 80: ICOS+ CD4 EM | 0.2 | - |
| Week 0: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 54: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 80: ICOS+ CD4 TEMRA | 0.0 | - |
| Week 0: ICOS+ NAIVE CD4 T-Cells | 0.1 | - |
| Week 54: ICOS+ NAIVE CD4 T-Cells | 0.1 | - |
| Week 80: ICOS+ NAIVE CD4 T-Cells | 0.0 | - |
| Week 0: ICOS+ NAIVE TREG | 2.5 | - |
| Week 54: ICOS+ NAIVE TREG | 2.4 | - |
| Week 80: ICOS+ NAIVE TREG | 2.7 | - |
| Week 0: ICOS+ TREG CM | 11.0 | - |
| Week 54: ICOS+ TREG CM | 10.6 | - |
| Week 80: ICOS+ TREG CM | 10.5 | - |
| Week 0: ICOS+ TREG EM | 12.8 | - |
| Week 54: ICOS+ TREG EM | 12.7 | - |
| Week 80: ICOS+ TREG EM | 12.0 | - |
| Week 0: ICOS+ TREG TEMRA | 9.3 | - |
| Week 54: ICOS+ TREG TEMRA | 12.8 | - |
| Week 80: ICOS+ TREG TEMRA | 11.0 | - |
| Week 0: PD1+ CD4 Central Memory | 6.6 | - |
| Week 54: PD1+ CD4 Central Memory | 6.7 | - |
| Week 80: PD1+ CD4 Central Memory | 7.2 | - |
| Week 0: PD1+ CD4 Effector Memory | 4.1 | - |
| Week 54: PD1+ CD4 Effector Memory | 4.0 | - |
| Week 80: PD1+ CD4 Effector Memory | 4.3 | - |
| Week 0: PD1+ Naive CD4 | 3.2 | - |
| Week 54: PD1+ Naive CD4 | 3.5 | - |
| Week 80: PD1+ Naive CD4 | 3.8 | - |
| Week 0: PD1+ Naive TREG | 8.5 | - |
| Week 54: PD1+ Naive TREG | 9.4 | - |
| Week 80: PD1+ Naive TREG | 10.7 | - |
| Week 0: PD1+ TEMRA TREG | 19.5 | - |
| Week 54: PD1+ TEMRA TREG | 21.4 | - |
| Week 80: PD1+ TEMRA TREG | 22.7 | - |
| Week 0: PD1+ TREG CM | 17.2 | - |
| Week 54: PD1+ TREG CM | 18.0 | - |
| Week 80: PD1+ TREG CM | 18.8 | - |
| Week 0: PD1+ TREG EM | 20.9 | - |
| Week 54: PD1+ TREG EM | 21.6 | - |
| Week 80: PD1+ TREG EM | 21.9 | - |
| Week 0: PD1+ICOSNeg cTfh1 | 29.7 | - |
| Week 54: PD1+ICOSNeg cTfh1 | 31.0 | - |
| Week 80: PD1+ICOSNeg cTfh1 | 32.8 | - |
| Week 0: PD1+ICOSNeg cTfh17 | 22.3 | - |
| Week 54: PD1+ICOSNeg cTfh17 | 21.7 | - |
| Week 80: PD1+ICOSNeg cTfh17 | 24.3 | - |
| Week 0: PD1+ICOSNeg cTfh2 | 18.5 | - |
| Week 54: PD1+ICOSNeg cTfh2 | 18.8 | - |
| Week 80: PD1+ICOSNeg cTfh2 | 20.2 | - |
| Week 0: PD1- ICOS- cTfh1 | 68.9 | - |
| Week 54: PD1- ICOS- cTfh1 | 67.5 | - |
| Week 80: PD1- ICOS- cTfh1 | 65.9 | - |
| Week 0: PD1- ICOS- cTfh17 | 75.3 | - |
| Week 54: PD1- ICOS- cTfh17 | 73.5 | - |
| Week 80: PD1- ICOS- cTfh17 | 74.6 | - |
| Week 0: PD1- ICOS- cTfh2 | 80.7 | - |
| Week 54: PD1- ICOS- cTfh2 | 80.3 | - |
| Week 80: PD1- ICOS- cTfh2 | 79.0 | - |
| Week 0: Potentially Anergic TEMRA CD4 | 0.3 | - |
| Week 54: Potentially Anergic TEMRA CD4 | 0.3 | - |
| Week 80: Potentially Anergic TEMRA CD4 | 0.3 | - |
| Week 0: Regulatory T-Follicular Subset | 0.2 | - |
| Week 54: Regulatory T-Follicular Subset | 0.3 | - |
| Week 80: Regulatory T-Follicular Subset | 0.3 | - |
| Week 0: TH17-Like Circulating T-Follicular cells | 0.5 | - |
| Week 54: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 80: TH17-Like Circulating T-Follicular cells | 0.4 | - |
| Week 0: TH2-Like Circulating T-Follicular Cells | 4.1 | - |
| Week 54: TH2-Like Circulating T-Follicular Cells | 3.9 | - |
| Week 80: TH2-Like Circulating T-Follicular Cells | 3.8 | - |
| Week 0: TIGIT+ cTfh1 | 51.6 | - |
| Week 54: TIGIT+ cTfh1 | 50.2 | - |
| Week 80: TIGIT+ cTfh1 | 52.7 | - |
| Week 0: TIGIT+ cTfh17 | 38.7 | - |
| Week 54: TIGIT+ cTfh17 | 35.8 | - |
| Week 80: TIGIT+ cTfh17 | 36.8 | - |
| Week 0: TIGIT+ cTfh2 | 43.4 | - |
| Week 54: TIGIT+ cTfh2 | 41.0 | - |
| Week 80: TIGIT+ cTfh2 | 41.9 | - |
| Week 0: TOTAL ICOS+ TREG | 8.9 | - |
| Week 54: TOTAL ICOS+ TREG | 8.6 | - |
| Week 80: TOTAL ICOS+ TREG | 8.6 | - |
| Week 0: Th1-Like Circulating T-Follicular Cells | 1.5 | - |
| Week 54: Th1-Like Circulating T-Follicular Cells | 1.8 | - |
| Week 80: Th1-Like Circulating T-Follicular Cells | 1.6 | - |
| Week 0: Total PD1+ TREG | 14.4 | - |
| Week 54: Total PD1+ TREG | 15.0 | - |
| Week 80: Total PD1+ TREG | 16.1 | - |
Secondary/registry result
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · Percentage of Myeloid cells (%) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: CD14+ HLA low Myeloid Cells | 1.1 | - |
| Week 54: CD14+ HLA low Myeloid Cells | 1.1 | - |
| Week 80: CD14+ HLA low Myeloid Cells | 1.0 | - |
| Week 0: CD14+ MDSC | 68.2 | - |
| Week 54: CD14+ MDSC | 64.0 | - |
| Week 80: CD14+ MDSC | 65.7 | - |
| Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 80.4 | - |
| Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 80.9 | - |
| Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 79.0 | - |
| Week 0: CD16+ Dendritic Cells | 12.5 | - |
| Week 54: CD16+ Dendritic Cells | 10.2 | - |
| Week 80: CD16+ Dendritic Cells | 11.7 | - |
| Week 0: IMMYE_MDSC | 0.3 | - |
| Week 54: IMMYE_MDSC | 0.2 | - |
| Week 80: IMMYE_MDSC | 0.2 | - |
| Week 0: Intermediate Monocyte Subset | 8.6 | - |
| Week 54: Intermediate Monocyte Subset | 6.5 | - |
| Week 80: Intermediate Monocyte Subset | 6.0 | - |
| Week 0: Non-Classical Monocytes | 1.5 | - |
| Week 54: Non-Classical Monocytes | 1.2 | - |
| Week 80: Non-Classical Monocytes | 1.2 | - |
| Week 0: Total Classical Monocytes | 87.2 | - |
| Week 54: Total Classical Monocytes | 87.8 | - |
| Week 80: Total Classical Monocytes | 89.3 | - |
| Week 0: Total Monocytes in Myeloid Cells | 14.2 | - |
| Week 54: Total Monocytes in Myeloid Cells | 13.8 | - |
| Week 80: Total Monocytes in Myeloid Cells | 15.5 | - |
| Week 0: Total Myeloid DC | 3.8 | - |
| Week 54: Total Myeloid DC | 3.7 | - |
| Week 80: Total Myeloid DC | 4.1 | - |
| Week 0: Total MYDC | 30.4 | - |
| Week 54: Total MYDC | 30.4 | - |
| Week 80: Total MYDC | 28.7 | - |
| Week 0: Total Percent Of Myeloid Cells | 94.6 | - |
| Week 54: Total Percent Of Myeloid Cells | 95.1 | - |
| Week 80: Total Percent Of Myeloid Cells | 94.8 | - |
| Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 14.3 | - |
| Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 14.4 | - |
| Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 13.5 | - |
| NNC0114-0006 (Experimental)Week 0: CD14+ HLA low Myeloid Cells | 1.0 | - |
| Week 54: CD14+ HLA low Myeloid Cells | 0.7 | - |
| Week 80: CD14+ HLA low Myeloid Cells | 0.6 | - |
| Week 0: CD14+ MDSC | 69.1 | - |
| Week 54: CD14+ MDSC | 67.0 | - |
| Week 80: CD14+ MDSC | 62.7 | - |
| Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 82.2 | - |
| Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 80.0 | - |
| Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 81.0 | - |
| Week 0: CD16+ Dendritic Cells | 11.3 | - |
| Week 54: CD16+ Dendritic Cells | 10.3 | - |
| Week 80: CD16+ Dendritic Cells | 9.4 | - |
| Week 0: IMMYE_MDSC | 0.2 | - |
| Week 54: IMMYE_MDSC | 0.2 | - |
| Week 80: IMMYE_MDSC | 0.1 | - |
| Week 0: Intermediate Monocyte Subset | 9.0 | - |
| Week 54: Intermediate Monocyte Subset | 7.3 | - |
| Week 80: Intermediate Monocyte Subset | 6.6 | - |
| Week 0: Non-Classical Monocytes | 1.3 | - |
| Week 54: Non-Classical Monocytes | 1.3 | - |
| Week 80: Non-Classical Monocytes | 1.2 | - |
| Week 0: Total Classical Monocytes | 86.7 | - |
| Week 54: Total Classical Monocytes | 88.1 | - |
| Week 80: Total Classical Monocytes | 88.5 | - |
| Week 0: Total Monocytes in Myeloid Cells | 12.6 | - |
| Week 54: Total Monocytes in Myeloid Cells | 14.9 | - |
| Week 80: Total Monocytes in Myeloid Cells | 13.8 | - |
| Week 0: Total Myeloid DC | 3.6 | - |
| Week 54: Total Myeloid DC | 3.9 | - |
| Week 80: Total Myeloid DC | 4.1 | - |
| Week 0: Total MYDC | 31.4 | - |
| Week 54: Total MYDC | 31.3 | - |
| Week 80: Total MYDC | 30.5 | - |
| Week 0: Total Percent Of Myeloid Cells | 94.7 | - |
| Week 54: Total Percent Of Myeloid Cells | 95.9 | - |
| Week 80: Total Percent Of Myeloid Cells | 95.6 | - |
| Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 12.5 | - |
| Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 13.5 | - |
| Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 12.8 | - |
| Liraglutide (Experimental)Week 0: CD14+ HLA low Myeloid Cells | 0.9 | - |
| Week 54: CD14+ HLA low Myeloid Cells | 0.7 | - |
| Week 80: CD14+ HLA low Myeloid Cells | 0.9 | - |
| Week 0: CD14+ MDSC | 73.5 | - |
| Week 54: CD14+ MDSC | 69.3 | - |
| Week 80: CD14+ MDSC | 64.1 | - |
| Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 80.8 | - |
| Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 80.8 | - |
| Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 80.9 | - |
| Week 0: CD16+ Dendritic Cells | 12.9 | - |
| Week 54: CD16+ Dendritic Cells | 11.2 | - |
| Week 80: CD16+ Dendritic Cells | 9.2 | - |
| Week 0: IMMYE_MDSC | 0.2 | - |
| Week 54: IMMYE_MDSC | 0.2 | - |
| Week 80: IMMYE_MDSC | 0.2 | - |
| Week 0: Intermediate Monocyte Subset | 8.3 | - |
| Week 54: Intermediate Monocyte Subset | 6.3 | - |
| Week 80: Intermediate Monocyte Subset | 5.7 | - |
| Week 0: Non-Classical Monocytes | 1.2 | - |
| Week 54: Non-Classical Monocytes | 1.1 | - |
| Week 80: Non-Classical Monocytes | 1.0 | - |
| Week 0: Total Classical Monocytes | 87.6 | - |
| Week 54: Total Classical Monocytes | 88.0 | - |
| Week 80: Total Classical Monocytes | 88.6 | - |
| Week 0: Total Monocytes in Myeloid Cells | 14.1 | - |
| Week 54: Total Monocytes in Myeloid Cells | 14.3 | - |
| Week 80: Total Monocytes in Myeloid Cells | 13.6 | - |
| Week 0: Total Myeloid DC | 3.8 | - |
| Week 54: Total Myeloid DC | 3.8 | - |
| Week 80: Total Myeloid DC | 4.1 | - |
| Week 0: Total MYDC | 32.7 | - |
| Week 54: Total MYDC | 31.7 | - |
| Week 80: Total MYDC | 31.6 | - |
| Week 0: Total Percent Of Myeloid Cells | 94.6 | - |
| Week 54: Total Percent Of Myeloid Cells | 95.0 | - |
| Week 80: Total Percent Of Myeloid Cells | 94.6 | - |
| Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 12.0 | - |
| Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 12.0 | - |
| Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 11.6 | - |
| Placebo (Placebo)Week 0: CD14+ HLA low Myeloid Cells | 1.0 | - |
| Week 54: CD14+ HLA low Myeloid Cells | 0.6 | - |
| Week 80: CD14+ HLA low Myeloid Cells | 0.8 | - |
| Week 0: CD14+ MDSC | 70.3 | - |
| Week 54: CD14+ MDSC | 65.9 | - |
| Week 80: CD14+ MDSC | 63.9 | - |
| Week 0: CD14-HLA II- Myeloid Cells Total Myeloid | 81.8 | - |
| Week 54: CD14-HLA II- Myeloid Cells Total Myeloid | 83.5 | - |
| Week 80: CD14-HLA II- Myeloid Cells Total Myeloid | 81.3 | - |
| Week 0: CD16+ Dendritic Cells | 11.5 | - |
| Week 54: CD16+ Dendritic Cells | 12.0 | - |
| Week 80: CD16+ Dendritic Cells | 12.1 | - |
| Week 0: IMMYE_MDSC | 0.2 | - |
| Week 54: IMMYE_MDSC | 0.1 | - |
| Week 80: IMMYE_MDSC | 0.2 | - |
| Week 0: Intermediate Monocyte Subset | 7.7 | - |
| Week 54: Intermediate Monocyte Subset | 5.8 | - |
| Week 80: Intermediate Monocyte Subset | 5.8 | - |
| Week 0: Non-Classical Monocytes | 1.3 | - |
| Week 54: Non-Classical Monocytes | 1.2 | - |
| Week 80: Non-Classical Monocytes | 1.3 | - |
| Week 0: Total Classical Monocytes | 88.0 | - |
| Week 54: Total Classical Monocytes | 89.3 | - |
| Week 80: Total Classical Monocytes | 89.7 | - |
| Week 0: Total Monocytes in Myeloid Cells | 13.4 | - |
| Week 54: Total Monocytes in Myeloid Cells | 12.2 | - |
| Week 80: Total Monocytes in Myeloid Cells | 13.5 | - |
| Week 0: Total Myeloid DC | 3.4 | - |
| Week 54: Total Myeloid DC | 3.2 | - |
| Week 80: Total Myeloid DC | 3.9 | - |
| Week 0: Total MYDC | 31.0 | - |
| Week 54: Total MYDC | 27.2 | - |
| Week 80: Total MYDC | 31.9 | - |
| Week 0: Total Percent Of Myeloid Cells | 94.6 | - |
| Week 54: Total Percent Of Myeloid Cells | 95.6 | - |
| Week 80: Total Percent Of Myeloid Cells | 94.1 | - |
| Week 0: Total Plasmacytoid Dendritic Cells (PDC) | 12.9 | - |
| Week 54: Total Plasmacytoid Dendritic Cells (PDC) | 11.8 | - |
| Week 80: Total Plasmacytoid Dendritic Cells (PDC) | 12.5 | - |
Secondary/registry result
Change in Biomarker: Total Interleukin-21 (IL-21)
Time frame:Week 0, week 54 and week 80
IL-21
change from baseline, descriptive
Posted result
| Group | Mean · picogram per milliliter | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 28.8 | - |
| Week 54 | 3993.5 | - |
| Week 80 | 540.9 | - |
| NNC0114-0006 (Experimental)Week 0 | 31.1 | - |
| Week 54 | 4368.2 | - |
| Week 80 | 674.1 | - |
| Liraglutide (Experimental)Week 0 | 30.9 | - |
| Week 54 | 25.0 | - |
| Week 80 | 28.0 | - |
| Placebo (Placebo)Week 0 | 30.2 | - |
| Week 54 | 34.1 | - |
| Week 80 | 30.7 | - |
Secondary/registry result
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Posted result
| Group | Mean · picomole per liter | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 123 | - |
| Week 54 | 117 | - |
| Week 80 | 119 | - |
| NNC0114-0006 (Experimental)Week 0 | 122 | - |
| Week 54 | 125 | - |
| Week 80 | 124 | - |
| Liraglutide (Experimental)Week 0 | 122 | - |
| Week 54 | 113 | - |
| Week 80 | 121 | - |
| Placebo (Placebo)Week 0 | 120 | - |
| Week 54 | 119 | - |
| Week 80 | 115 | - |
Secondary/protocol endpoint
Change in Biochemistry: C-reactive Protein Serum
Time frame:(Week 0, week 54) and (week 0, week 80)
hs-CRP, change
ratio, improvement
LOINC 30522-7
Secondary/protocol endpoint
Change in Biochemistry: Magnesium
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Biochemistry: Uric Acid
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint
Change in D-Dimer
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint
Change in Lipids: Total Cholesterol (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Secondary/protocol endpoint
Change in Lipids: Free Fatty Acids (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
Free fatty acids, change
ratio, improvement
Secondary/protocol endpoint
Change in Lipids: HDL Cholesterol (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
HDL-C, change
ratio, improvement
LOINC 2085-9
Secondary/protocol endpoint
Change in Lipids: LDL Cholesterol (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
LDL-C, change
ratio, improvement
LOINC 13457-7
Secondary/protocol endpoint
Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
Time frame:(Week 0, week 54) and (week 0, week 80)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Secondary/protocol endpoint
Change in Systolic and Diastolic Blood Pressure
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Secondary/protocol endpoint
Change in Pulse
Time frame:(Week 0, week 54) and (week 0, week 80)
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
6 endpointsSecondary/registry result
Change in Short Form 36 Health Survey (SF-36)
Time frame:(Week 0, week 54) and (week 0, week 80)
SF-36 total
change from baseline, improvement
Posted result
| Group | Mean · Score on a scale | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 54: Bodily pain | -0.8 | - |
| Week 80: Bodily Pain | 0.8 | - |
| Week 54: General Health Perception | -1.1 | - |
| Week 80: General Health Perception | -0.9 | - |
| Week 54: Mental Component Sum | 0.5 | - |
| Week 80: Mental Component Sum | 1.7 | - |
| week 54: Mental Health | 0.7 | - |
| Week 80: Mental Health | 1.5 | - |
| Week 54: Physical Component Sum | -0.4 | - |
| Week 80: Physical Component Sum | -0.1 | - |
| Week 54: Physical Functioning | 0.6 | - |
| Week 80: Physical Functioning | 0.5 | - |
| Week 54:Lim Emotion Prob | 0.3 | - |
| Week 80: Lim Emotion Prob | 1.2 | - |
| Week 54: Lim. Phy Health | 0.3 | - |
| Week 80: Lim. Phy Health | 0.8 | - |
| Week 54: Social Functioning | 0.8 | - |
| Week 80: Social Functioning | 2.3 | - |
| Week 54: Vitality | -0.5 | - |
| Week 80: Vitality | 0.5 | - |
| NNC0114-0006 (Experimental)Week 54: Bodily pain | -2.2 | - |
| Week 80: Bodily Pain | -1.4 | - |
| Week 54: General Health Perception | -0.3 | - |
| Week 80: General Health Perception | 0.6 | - |
| Week 54: Mental Component Sum | 0.6 | - |
| Week 80: Mental Component Sum | -0.4 | - |
| week 54: Mental Health | 0.6 | - |
| Week 80: Mental Health | -0.2 | - |
| Week 54: Physical Component Sum | -0.4 | - |
| Week 80: Physical Component Sum | 0.5 | - |
| Week 54: Physical Functioning | 0.9 | - |
| Week 80: Physical Functioning | 1.1 | - |
| Week 54:Lim Emotion Prob | 0.5 | - |
| Week 80: Lim Emotion Prob | -0.1 | - |
| Week 54: Lim. Phy Health | 0.7 | - |
| Week 80: Lim. Phy Health | 0.9 | - |
| Week 54: Social Functioning | 0.1 | - |
| Week 80: Social Functioning | 1.0 | - |
| Week 54: Vitality | 0.5 | - |
| Week 80: Vitality | -1.4 | - |
| Liraglutide (Experimental)Week 54: Bodily pain | 0.1 | - |
| Week 80: Bodily Pain | -0.5 | - |
| Week 54: General Health Perception | -1.6 | - |
| Week 80: General Health Perception | -1.7 | - |
| Week 54: Mental Component Sum | -2.1 | - |
| Week 80: Mental Component Sum | -2.4 | - |
| week 54: Mental Health | -1.5 | - |
| Week 80: Mental Health | -1.5 | - |
| Week 54: Physical Component Sum | -0.1 | - |
| Week 80: Physical Component Sum | 0.0 | - |
| Week 54: Physical Functioning | 0.0 | - |
| Week 80: Physical Functioning | -0.1 | - |
| Week 54:Lim Emotion Prob | -1.4 | - |
| Week 80: Lim Emotion Prob | -2.2 | - |
| Week 54: Lim. Phy Health | -0.6 | - |
| Week 80: Lim. Phy Health | -0.2 | - |
| Week 54: Social Functioning | -1.4 | - |
| Week 80: Social Functioning | -1.2 | - |
| Week 54: Vitality | -2.2 | - |
| Week 80: Vitality | -2.2 | - |
| Placebo (Placebo)Week 54: Bodily pain | 0.6 | - |
| Week 80: Bodily Pain | 0.8 | - |
| Week 54: General Health Perception | -1.0 | - |
| Week 80: General Health Perception | -1.8 | - |
| Week 54: Mental Component Sum | -1.3 | - |
| Week 80: Mental Component Sum | -0.7 | - |
| week 54: Mental Health | -1.3 | - |
| Week 80: Mental Health | -0.7 | - |
| Week 54: Physical Component Sum | 0.3 | - |
| Week 80: Physical Component Sum | 0.0 | - |
| Week 54: Physical Functioning | 0.3 | - |
| Week 80: Physical Functioning | 0.1 | - |
| Week 54:Lim Emotion Prob | -0.1 | - |
| Week 80: Lim Emotion Prob | 0.0 | - |
| Week 54: Lim. Phy Health | -0.2 | - |
| Week 80: Lim. Phy Health | 0.0 | - |
| Week 54: Social Functioning | 0.0 | - |
| Week 80: Social Functioning | -0.4 | - |
| Week 54: Vitality | -2.3 | - |
| Week 80: Vitality | -0.7 | - |
Secondary/registry result
Change in Experience of Treatment Benefits and Barriers (ETBB)
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Posted result
| Group | Median · score on a scale | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 54: Total Score for Perceived Barriers | -1.2 | - |
| Week 80: Total Score for Perceived Barriers | -2.0 | - |
| Week 54: Total Score for Perceived Benefits | 0.6 | - |
| Week 80: Total Score for Perceived Benefits | 0.1 | - |
| NNC0114-0006 (Experimental)Week 54: Total Score for Perceived Barriers | -1.8 | - |
| Week 80: Total Score for Perceived Barriers | -2.0 | - |
| Week 54: Total Score for Perceived Benefits | 1.1 | - |
| Week 80: Total Score for Perceived Benefits | 1.1 | - |
| Liraglutide (Experimental)Week 54: Total Score for Perceived Barriers | -0.2 | - |
| Week 80: Total Score for Perceived Barriers | -0.1 | - |
| Week 54: Total Score for Perceived Benefits | 0.2 | - |
| Week 80: Total Score for Perceived Benefits | 1.3 | - |
| Placebo (Placebo)Week 54: Total Score for Perceived Barriers | -0.3 | - |
| Week 80: Total Score for Perceived Barriers | 0.1 | - |
| Week 54: Total Score for Perceived Benefits | -0.5 | - |
| Week 80: Total Score for Perceived Benefits | -0.4 | - |
Secondary/registry result
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Posted result
| Group | Mean · Score on a scale | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 54: Perceived frequency of hyperglycaemia | 0.6 | - |
| Week 80: Perceived frequency of hyperglycaemia | 0.9 | - |
| Week 54: Perceived frequency of hypoglycaemia | -0.7 | - |
| Week 80: Perceived frequency of hypoglycaemia | -0.9 | - |
| Week 54: Treatment satisfaction | 1.5 | - |
| Week 80: Treatment satisfaction | 1.3 | - |
| NNC0114-0006 (Experimental)Week 54: Perceived frequency of hyperglycaemia | 0.0 | - |
| Week 80: Perceived frequency of hyperglycaemia | 0.5 | - |
| Week 54: Perceived frequency of hypoglycaemia | -0.6 | - |
| Week 80: Perceived frequency of hypoglycaemia | -0.3 | - |
| Week 54: Treatment satisfaction | 0.9 | - |
| Week 80: Treatment satisfaction | 1.2 | - |
| Liraglutide (Experimental)Week 54: Perceived frequency of hyperglycaemia | 0.0 | - |
| Week 80: Perceived frequency of hyperglycaemia | 0.6 | - |
| Week 54: Perceived frequency of hypoglycaemia | -0.4 | - |
| Week 80: Perceived frequency of hypoglycaemia | -0.4 | - |
| Week 54: Treatment satisfaction | 1.3 | - |
| Week 80: Treatment satisfaction | 0.0 | - |
| Placebo (Placebo)Week 54: Perceived frequency of hyperglycaemia | 0.5 | - |
| Week 80: Perceived frequency of hyperglycaemia | 0.7 | - |
| Week 54: Perceived frequency of hypoglycaemia | -0.2 | - |
| Week 80: Perceived frequency of hypoglycaemia | -0.1 | - |
| Week 54: Treatment satisfaction | 0.2 | - |
| Week 80: Treatment satisfaction | 0.2 | - |
Secondary/protocol endpoint
Change in Short Form 36 Health Survey (SF-36)
Time frame:(Week 0, week 54) and (week 0, week 80)
SF-36 total
change from baseline, improvement
Secondary/protocol endpoint
Change in Experience of Treatment Benefits and Barriers (ETBB)
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Secondary/protocol endpoint
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, improvement
Safety / tolerability / PK
96 endpointsSecondary/registry result
Number of Treatment Emergent Adverse Events
Time frame:Week 0-54; Week 54-80
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Number · Adverse events | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0-54 | 434 | - |
| Week 54-80 | 70 | - |
| NNC0114-0006 (Experimental)Week 0-54 | 327 | - |
| Week 54-80 | 73 | - |
| Liraglutide (Experimental)Week 0-54 | 410 | - |
| Week 54-80 | 78 | - |
| Placebo (Placebo)Week 0-54 | 364 | - |
| Week 54-80 | 87 | - |
Secondary/registry result
Number of Treatment Emergent Hyperglycaemic Episodes
Time frame:Week 0-54; Week 54-80
event count, event
Posted result
| Group | Number · Episodes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0-54 | 302 | - |
| Week 54-80 | 306 | - |
| NNC0114-0006 (Experimental)Week 0-54 | 256 | - |
| Week 54-80 | 74 | - |
| Liraglutide (Experimental)Week 0-54 | 217 | - |
| Week 54-80 | 352 | - |
| Placebo (Placebo)Week 0-54 | 291 | - |
| Week 54-80 | 112 | - |
Secondary/registry result
Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
Time frame:Weeks 0-54; Weeks 54-80
event count, event
Posted result
| Group | Number · Episodes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0-54 | 0 | - |
| Week 54-80 | 0 | - |
| NNC0114-0006 (Experimental)Week 0-54 | 0 | - |
| Week 54-80 | 0 | - |
| Liraglutide (Experimental)Week 0-54 | 0 | - |
| Week 54-80 | 1 | - |
| Placebo (Placebo)Week 0-54 | 0 | - |
| Week 54-80 | 1 | - |
Secondary/registry result
Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
Time frame:Week 0-54
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 2 | - |
| NNC0114-0006 (Experimental) | 0 | - |
| Liraglutide (Experimental) | 0 | - |
| Placebo (Placebo) | 1 | - |
Secondary/registry result
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
Time frame:Weeks 0-54; Weeks 54-80
Documented hypoglycemia
event count, event
Posted result
| Group | Number · Episodes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Severe hypoglycaemia (Week 0-54) | 1 | - |
| Asymptomatic hypoglycaemia (Week 0-54) | 2038 | - |
| Documented symptomatic hypoglycaemia (Week 0-54) | 1305 | - |
| Pseudo-hypoglycaemia (Week 0-54) | 1 | - |
| Probable symptomatic hypoglycaemia (Week 0-54) | 9 | - |
| Severe hypoglycaemia (Week 54-80) | 3 | - |
| Asymptomatic hypoglycaemia (Week 54-80) | 609 | - |
| Documented symptomatic hypoglycaemia (Week 54-80) | 514 | - |
| Pseudo-hypoglycaemia (Week 54-80) | 0 | - |
| Probable symptomatic hypoglycaemia (Week 54-80) | 1 | - |
| NNC0114-0006 (Experimental)Severe hypoglycaemia (Week 0-54) | 2 | - |
| Asymptomatic hypoglycaemia (Week 0-54) | 1956 | - |
| Documented symptomatic hypoglycaemia (Week 0-54) | 1461 | - |
| Pseudo-hypoglycaemia (Week 0-54) | 1 | - |
| Probable symptomatic hypoglycaemia (Week 0-54) | 0 | - |
| Severe hypoglycaemia (Week 54-80) | 1 | - |
| Asymptomatic hypoglycaemia (Week 54-80) | 522 | - |
| Documented symptomatic hypoglycaemia (Week 54-80) | 362 | - |
| Pseudo-hypoglycaemia (Week 54-80) | 0 | - |
| Probable symptomatic hypoglycaemia (Week 54-80) | 0 | - |
| Liraglutide (Experimental)Severe hypoglycaemia (Week 0-54) | 0 | - |
| Asymptomatic hypoglycaemia (Week 0-54) | 2092 | - |
| Documented symptomatic hypoglycaemia (Week 0-54) | 1114 | - |
| Pseudo-hypoglycaemia (Week 0-54) | 14 | - |
| Probable symptomatic hypoglycaemia (Week 0-54) | 4 | - |
| Severe hypoglycaemia (Week 54-80) | 0 | - |
| Asymptomatic hypoglycaemia (Week 54-80) | 670 | - |
| Documented symptomatic hypoglycaemia (Week 54-80) | 651 | - |
| Pseudo-hypoglycaemia (Week 54-80) | 1 | - |
| Probable symptomatic hypoglycaemia (Week 54-80) | 0 | - |
| Placebo (Placebo)Severe hypoglycaemia (Week 0-54) | 0 | - |
| Asymptomatic hypoglycaemia (Week 0-54) | 1774 | - |
| Documented symptomatic hypoglycaemia (Week 0-54) | 1625 | - |
| Pseudo-hypoglycaemia (Week 0-54) | 2 | - |
| Probable symptomatic hypoglycaemia (Week 0-54) | 10 | - |
| Severe hypoglycaemia (Week 54-80) | 1 | - |
| Asymptomatic hypoglycaemia (Week 54-80) | 449 | - |
| Documented symptomatic hypoglycaemia (Week 54-80) | 527 | - |
| Pseudo-hypoglycaemia (Week 54-80) | 2 | - |
| Probable symptomatic hypoglycaemia (Week 54-80) | 2 | - |
Secondary/registry result
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
Time frame:Weeks 0-54; Weeks 54-80
Documented hypoglycemia
event count, event
Posted result
| Group | Number · Episodes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Severe or BG confirmed (Week 0-54) | 396 | - |
| Symptomatic BG confirmed (Week 0-54) | 576 | - |
| Severe or BG confirmed (Week 54-80) | 216 | - |
| Symptomatic BG confirmed (Week 54-80) | 368 | - |
| NNC0114-0006 (Experimental)Severe or BG confirmed (Week 0-54) | 394 | - |
| Symptomatic BG confirmed (Week 0-54) | 616 | - |
| Severe or BG confirmed (Week 54-80) | 130 | - |
| Symptomatic BG confirmed (Week 54-80) | 207 | - |
| Liraglutide (Experimental)Severe or BG confirmed (Week 0-54) | 315 | - |
| Symptomatic BG confirmed (Week 0-54) | 479 | - |
| Severe or BG confirmed (Week 54-80) | 244 | - |
| Symptomatic BG confirmed (Week 54-80) | 332 | - |
| Placebo (Placebo)Severe or BG confirmed (Week 0-54) | 503 | - |
| Symptomatic BG confirmed (Week 0-54) | 646 | - |
| Severe or BG confirmed (Week 54-80) | 240 | - |
| Symptomatic BG confirmed (Week 54-80) | 292 | - |
Secondary/registry result
Change in Haematology: Erythrocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of erythrocytes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.99 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/registry result
Change in Haematology: Haematocrit
Time frame:(Week 0, week 54) and (week 0, week 80)
haematocrit
change from baseline, descriptive
LOINC 20570-8
Posted result
| Group | Geometric mean · ratio of haematocrit | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Haematology: Haemoglobin
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of haemoglobin | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.00 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.01 | - |
Secondary/registry result
Change in Haematology: Leukocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of leukocytes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.99 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.95 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/registry result
Change in Haematology: Mean Corpuscular Hemoglobin
Time frame:(Week 0, week 54) and (week 0, week 80)
MCH
change from baseline, descriptive
Posted result
| Group | Mean · ratio of mean Corpuscular hemoglobin | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.02 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.01 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.01 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.02 | - |
Secondary/registry result
Change in Haematology: Mean Corpuscular Hemoglobin Concentration
Time frame:(Week 0, week 54) and (week 0, week 80)
MCHC
change from baseline, descriptive
LOINC 786-4
Posted result
| Group | Geometric mean · Ratio of MCHC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.02 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.02 | - |
Secondary/registry result
Change in Haematology: Mean Corpuscular Volume
Time frame:(Week 0, week 54) and (week 0, week 80)
MCV
change from baseline, descriptive
Posted result
| Group | Geometric mean · ratio of mean corpuscular volume | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Haematology: Thrombocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of thrombocytes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 1.00 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 1.03 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.04 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/registry result
Change in Haematology: Eosinophil
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Mean · Ratio of eosinophils | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.15 | - |
| Change from week 0 to week 80 | 1.31 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.30 | - |
| Change from week 0 to week 80 | 1.23 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 3.10 | - |
| Change from week 0 to week 80 | 1.54 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.37 | - |
| Change from week 0 to week 80 | 1.36 | - |
Secondary/registry result
Change in Haematology: Neutrophils
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of neutrophils | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.97 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 1.04 | - |
Secondary/registry result
Change in Haematology: Basophils
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Posted result
| Group | Mean · Ratio of basophils | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.73 | - |
| Change from week 0 to week 80 | 2.17 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.58 | - |
| Change from week 0 to week 80 | 1.73 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.52 | - |
| Change from week 0 to week 80 | 2.09 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.43 | - |
| Change from week 0 to week 80 | 1.96 | - |
Secondary/registry result
Change in Haematology: Lymphocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of lymphocytes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.01 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.91 | - |
| Change from week 0 to week 80 | 0.91 | - |
Secondary/registry result
Change in Haematology: Monocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
monocytes
change from baseline, descriptive
Posted result
| Group | Geometric mean · ratio of monocytes | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.05 | - |
| Change from week 0 to week 80 | 1.12 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.07 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.04 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.12 | - |
Secondary/registry result
Change in Biochemistry: Albumin
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
LOINC 1751-7
Posted result
| Group | Mean · ratio of albumin | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.00 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.01 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.99 | - |
Secondary/registry result
Change in Biochemistry: Amylase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · ratio of Amylase | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.07 | - |
| Change from week 0 to week 80 | 1.04 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 1.03 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.04 | - |
Secondary/registry result
Change in Biochemistry: Calcium Corrected
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Posted result
| Group | Geometric mean · ratio of calcium | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.96 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.97 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
Secondary/registry result
Change in Biochemistry: Chloride
Time frame:(Week 0, week 54) and (week 0, week 80)
chloride
change from baseline, descriptive
LOINC 2075-0
Posted result
| Group | Geometric mean · ratio of chloride | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.00 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.01 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/registry result
Change in Biochemistry: Creatine Kinase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of Creatine Kinase | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.16 | - |
| Change from week 0 to week 80 | 1.11 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.17 | - |
| Change from week 0 to week 80 | 1.09 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.08 | - |
| Change from week 0 to week 80 | 1.24 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.13 | - |
Secondary/registry result
Change in Biochemistry: Lactate Dehydrogenase
Time frame:(Week 0, week 54) and (week 0, week 80)
LDH
change from baseline, descriptive
LOINC 14804-9
Posted result
| Group | Geometric mean · Ratio of Lactate Dehydrogenase | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 1.02 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.04 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.04 | - |
| Change from week 0 to week 80 | 1.09 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.03 | - |
| Change from week 0 to week 80 | 1.03 | - |
Secondary/registry result
Change in Biochemistry: Lipase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of lipase | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.49 | - |
| Change from week 0 to week 80 | 1.05 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.94 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.34 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 0.96 | - |
Secondary/registry result
Change in Biochemistry: Magnesium
Time frame:(Week 0, week 54) and (week 0, week 80)
serum magnesium
change from baseline, descriptive
LOINC 2601-3
Posted result
| Group | Geometric mean · Ratio of magnesium | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.01 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.03 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 1.02 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
Secondary/registry result
Change in Biochemistry: Potassium
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of potassium | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 0.99 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.98 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.98 | - |
| Change from week 0 to week 80 | 0.98 | - |
Secondary/registry result
Change in Biochemistry: Sodium
Time frame:(Week 0, week 54) and (week 0, week 80)
serum sodium
change from baseline, descriptive
LOINC 2951-2
Posted result
| Group | Geometric mean · Ratio of sodium | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.99 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/registry result
Change in Biochemistry: Total Protein
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Posted result
| Group | Geometric mean · Ratio of total protein | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.99 | - |
| Change from week 0 to week 80 | 0.99 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.01 | - |
| Change from week 0 to week 80 | 1.00 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.00 | - |
Secondary/registry result
Change in International Normalised Ratio (INR)
Time frame:(Week 0, week 54) and (week 0, week 80)
INR
change from baseline, descriptive
LOINC 6301-6
Posted result
| Group | Geometric mean · Ratio of INR | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 0.97 | - |
| Change from week 0 to week 80 | 0.98 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.95 | - |
| Change from week 0 to week 80 | 0.96 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.96 | - |
| Change from week 0 to week 80 | 0.97 | - |
Secondary/registry result
Change in Total Immunoglobulin E (IgE)
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of IgE | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.31 | - |
| Change from week 0 to week 80 | 1.32 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.05 | - |
| Change from week 0 to week 80 | 1.18 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 1.08 | - |
| Change from week 0 to week 80 | 1.16 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 1.02 | - |
| Change from week 0 to week 80 | 0.94 | - |
Secondary/registry result
Change in Urinalysis: Urine Dipsticks
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Glucose dipstick | 72 | - |
| Week 0: Glucose dipstick | 5 | - |
| Week 0: Glucose dipstick | 0 | - |
| Week 54: Glucose dipstick | 57 | - |
| Week 54: Glucose dipstick | 9 | - |
| Week 54: Glucose dipstick | 2 | - |
| Week 80: Glucose dipstick | 54 | - |
| Week 80: Glucose dipstick | 12 | - |
| Week 80: Glucose dipstick | 0 | - |
| Week 0: Ketone dipstick | 74 | - |
| Week 0: Ketone dipstick | 2 | - |
| Week 0: Ketone dipstick | 1 | - |
| Week 54: Ketone dipstick | 68 | - |
| Week 54: Ketone dipstick | 0 | - |
| Week 54: Ketone dipstick | 0 | - |
| Week 80: Ketone dipstick | 65 | - |
| Week 80: Ketone dipstick | 1 | - |
| Week 80: Ketone dipstick | 0 | - |
| Week 0: pH dipstick | 75 | - |
| Week 0: pH dipstick | 2 | - |
| Week 0: pH dipstick | 0 | - |
| Week 54: pH dipstick | 67 | - |
| Week 54: pH dipstick | 1 | - |
| Week 54: pH dipstick | 0 | - |
| Week 80: pH dipstick | 66 | - |
| Week 80: pH dipstick | 0 | - |
| Week 80: pH dipstick | 0 | - |
| Week 0: Erythrocytes in urine | 74 | - |
| Week 0: Erythrocytes in urine | 2 | - |
| Week 0: Erythrocytes in urine | 1 | - |
| Week 54: Erythrocytes in urine | 66 | - |
| Week 54: Erythrocytes in urine | 2 | - |
| Week 54: Erythrocytes in urine | 0 | - |
| Week 80: Erythrocytes in urine | 63 | - |
| Week 80: Erythrocytes in urine | 3 | - |
| Week 80: Erythrocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 77 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 54: Leukocytes in urine | 64 | - |
| Week 54: Leukocytes in urine | 4 | - |
| Week 54: Leukocytes in urine | 0 | - |
| Week 80: Leukocytes in urine | 62 | - |
| Week 80: Leukocytes in urine | 4 | - |
| Week 80: Leukocytes in urine | 0 | - |
| Week 0: Nitrite | 77 | - |
| Week 0: Nitrite | 0 | - |
| Week 0: Nitrite | 0 | - |
| Week 54: Nitrite | 68 | - |
| Week 54: Nitrite | 0 | - |
| Week 54: Nitrite | 0 | - |
| Week 80: Nitrite | 65 | - |
| Week 80: Nitrite | 1 | - |
| Week 80: Nitrite | 0 | - |
| Week 0: Protein urine | 77 | - |
| Week 0: Protein urine | 0 | - |
| Week 0: Protein urine | 0 | - |
| Week 54: Protein urine | 67 | - |
| Week 54: Protein urine | 1 | - |
| Week 54: Protein urine | 0 | - |
| Week 80: Protein urine | 63 | - |
| Week 80: Protein urine | 3 | - |
| Week 80: Protein urine | 0 | - |
| Week 0: Specific Gravity | 75 | - |
| Week 0: Specific Gravity | 2 | - |
| Week 0: Specific Gravity | 0 | - |
| Week 54: Specific Gravity | 67 | - |
| Week 54: Specific Gravity | 1 | - |
| Week 54: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 65 | - |
| Week 80: Specific Gravity | 1 | - |
| Week 80: Specific Gravity | 0 | - |
| NNC0114-0006 (Experimental)Week 0: Glucose dipstick | 71 | - |
| Week 0: Glucose dipstick | 6 | - |
| Week 0: Glucose dipstick | 0 | - |
| Week 54: Glucose dipstick | 56 | - |
| Week 54: Glucose dipstick | 9 | - |
| Week 54: Glucose dipstick | 0 | - |
| Week 80: Glucose dipstick | 54 | - |
| Week 80: Glucose dipstick | 10 | - |
| Week 80: Glucose dipstick | 0 | - |
| Week 0: Ketone dipstick | 73 | - |
| Week 0: Ketone dipstick | 4 | - |
| Week 0: Ketone dipstick | 0 | - |
| Week 54: Ketone dipstick | 64 | - |
| Week 54: Ketone dipstick | 1 | - |
| Week 54: Ketone dipstick | 0 | - |
| Week 80: Ketone dipstick | 61 | - |
| Week 80: Ketone dipstick | 3 | - |
| Week 80: Ketone dipstick | 0 | - |
| Week 0: pH dipstick | 77 | - |
| Week 0: pH dipstick | 0 | - |
| Week 0: pH dipstick | 0 | - |
| Week 54: pH dipstick | 65 | - |
| Week 54: pH dipstick | 0 | - |
| Week 54: pH dipstick | 0 | - |
| Week 80: pH dipstick | 64 | - |
| Week 80: pH dipstick | 0 | - |
| Week 80: pH dipstick | 0 | - |
| Week 0: Erythrocytes in urine | 74 | - |
| Week 0: Erythrocytes in urine | 3 | - |
| Week 0: Erythrocytes in urine | 0 | - |
| Week 54: Erythrocytes in urine | 63 | - |
| Week 54: Erythrocytes in urine | 2 | - |
| Week 54: Erythrocytes in urine | 0 | - |
| Week 80: Erythrocytes in urine | 61 | - |
| Week 80: Erythrocytes in urine | 3 | - |
| Week 80: Erythrocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 73 | - |
| Week 0: Leukocytes in urine | 4 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 54: Leukocytes in urine | 62 | - |
| Week 54: Leukocytes in urine | 3 | - |
| Week 54: Leukocytes in urine | 0 | - |
| Week 80: Leukocytes in urine | 61 | - |
| Week 80: Leukocytes in urine | 3 | - |
| Week 80: Leukocytes in urine | 0 | - |
| Week 0: Nitrite | 77 | - |
| Week 0: Nitrite | 0 | - |
| Week 0: Nitrite | 0 | - |
| Week 54: Nitrite | 65 | - |
| Week 54: Nitrite | 0 | - |
| Week 54: Nitrite | 0 | - |
| Week 80: Nitrite | 64 | - |
| Week 80: Nitrite | 0 | - |
| Week 80: Nitrite | 0 | - |
| Week 0: Protein urine | 71 | - |
| Week 0: Protein urine | 6 | - |
| Week 0: Protein urine | 0 | - |
| Week 54: Protein urine | 64 | - |
| Week 54: Protein urine | 1 | - |
| Week 54: Protein urine | 0 | - |
| Week 80: Protein urine | 62 | - |
| Week 80: Protein urine | 1 | - |
| Week 80: Protein urine | 1 | - |
| Week 0: Specific Gravity | 77 | - |
| Week 0: Specific Gravity | 0 | - |
| Week 0: Specific Gravity | 0 | - |
| Week 54: Specific Gravity | 65 | - |
| Week 54: Specific Gravity | 0 | - |
| Week 54: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 64 | - |
| Week 80: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 0 | - |
| Liraglutide (Experimental)Week 0: Glucose dipstick | 67 | - |
| Week 0: Glucose dipstick | 9 | - |
| Week 0: Glucose dipstick | 0 | - |
| Week 54: Glucose dipstick | 63 | - |
| Week 54: Glucose dipstick | 5 | - |
| Week 54: Glucose dipstick | 0 | - |
| Week 80: Glucose dipstick | 54 | - |
| Week 80: Glucose dipstick | 13 | - |
| Week 80: Glucose dipstick | 1 | - |
| Week 0: Ketone dipstick | 73 | - |
| Week 0: Ketone dipstick | 3 | - |
| Week 0: Ketone dipstick | 0 | - |
| Week 54: Ketone dipstick | 65 | - |
| Week 54: Ketone dipstick | 3 | - |
| Week 54: Ketone dipstick | 0 | - |
| Week 80: Ketone dipstick | 66 | - |
| Week 80: Ketone dipstick | 1 | - |
| Week 80: Ketone dipstick | 1 | - |
| Week 0: pH dipstick | 76 | - |
| Week 0: pH dipstick | 0 | - |
| Week 0: pH dipstick | 0 | - |
| Week 54: pH dipstick | 68 | - |
| Week 54: pH dipstick | 0 | - |
| Week 54: pH dipstick | 0 | - |
| Week 80: pH dipstick | 68 | - |
| Week 80: pH dipstick | 0 | - |
| Week 80: pH dipstick | 0 | - |
| Week 0: Erythrocytes in urine | 74 | - |
| Week 0: Erythrocytes in urine | 2 | - |
| Week 0: Erythrocytes in urine | 0 | - |
| Week 54: Erythrocytes in urine | 66 | - |
| Week 54: Erythrocytes in urine | 2 | - |
| Week 54: Erythrocytes in urine | 0 | - |
| Week 80: Erythrocytes in urine | 65 | - |
| Week 80: Erythrocytes in urine | 3 | - |
| Week 80: Erythrocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 76 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 54: Leukocytes in urine | 67 | - |
| Week 54: Leukocytes in urine | 1 | - |
| Week 54: Leukocytes in urine | 0 | - |
| Week 80: Leukocytes in urine | 67 | - |
| Week 80: Leukocytes in urine | 1 | - |
| Week 80: Leukocytes in urine | 0 | - |
| Week 0: Nitrite | 76 | - |
| Week 0: Nitrite | 0 | - |
| Week 0: Nitrite | 0 | - |
| Week 54: Nitrite | 68 | - |
| Week 54: Nitrite | 0 | - |
| Week 54: Nitrite | 0 | - |
| Week 80: Nitrite | 68 | - |
| Week 80: Nitrite | 0 | - |
| Week 80: Nitrite | 0 | - |
| Week 0: Protein urine | 75 | - |
| Week 0: Protein urine | 1 | - |
| Week 0: Protein urine | 0 | - |
| Week 54: Protein urine | 62 | - |
| Week 54: Protein urine | 6 | - |
| Week 54: Protein urine | 0 | - |
| Week 80: Protein urine | 65 | - |
| Week 80: Protein urine | 3 | - |
| Week 80: Protein urine | 0 | - |
| Week 0: Specific Gravity | 76 | - |
| Week 0: Specific Gravity | 0 | - |
| Week 0: Specific Gravity | 0 | - |
| Week 54: Specific Gravity | 68 | - |
| Week 54: Specific Gravity | 0 | - |
| Week 54: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 68 | - |
| Week 80: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 0 | - |
| Placebo (Placebo)Week 0: Glucose dipstick | 71 | - |
| Week 0: Glucose dipstick | 6 | - |
| Week 0: Glucose dipstick | 0 | - |
| Week 54: Glucose dipstick | 59 | - |
| Week 54: Glucose dipstick | 6 | - |
| Week 54: Glucose dipstick | 0 | - |
| Week 80: Glucose dipstick | 51 | - |
| Week 80: Glucose dipstick | 11 | - |
| Week 80: Glucose dipstick | 0 | - |
| Week 0: Ketone dipstick | 76 | - |
| Week 0: Ketone dipstick | 1 | - |
| Week 0: Ketone dipstick | 0 | - |
| Week 54: Ketone dipstick | 64 | - |
| Week 54: Ketone dipstick | 1 | - |
| Week 54: Ketone dipstick | 0 | - |
| Week 80: Ketone dipstick | 61 | - |
| Week 80: Ketone dipstick | 1 | - |
| Week 80: Ketone dipstick | 0 | - |
| Week 0: pH dipstick | 75 | - |
| Week 0: pH dipstick | 2 | - |
| Week 0: pH dipstick | 0 | - |
| Week 54: pH dipstick | 64 | - |
| Week 54: pH dipstick | 1 | - |
| Week 54: pH dipstick | 0 | - |
| Week 80: pH dipstick | 62 | - |
| Week 80: pH dipstick | 0 | - |
| Week 80: pH dipstick | 0 | - |
| Week 0: Erythrocytes in urine | 72 | - |
| Week 0: Erythrocytes in urine | 4 | - |
| Week 0: Erythrocytes in urine | 1 | - |
| Week 54: Erythrocytes in urine | 63 | - |
| Week 54: Erythrocytes in urine | 2 | - |
| Week 54: Erythrocytes in urine | 0 | - |
| Week 80: Erythrocytes in urine | 60 | - |
| Week 80: Erythrocytes in urine | 2 | - |
| Week 80: Erythrocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 77 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 0: Leukocytes in urine | 0 | - |
| Week 54: Leukocytes in urine | 64 | - |
| Week 54: Leukocytes in urine | 1 | - |
| Week 54: Leukocytes in urine | 0 | - |
| Week 80: Leukocytes in urine | 60 | - |
| Week 80: Leukocytes in urine | 2 | - |
| Week 80: Leukocytes in urine | 0 | - |
| Week 0: Nitrite | 77 | - |
| Week 0: Nitrite | 0 | - |
| Week 0: Nitrite | 0 | - |
| Week 54: Nitrite | 65 | - |
| Week 54: Nitrite | 0 | - |
| Week 54: Nitrite | 0 | - |
| Week 80: Nitrite | 61 | - |
| Week 80: Nitrite | 1 | - |
| Week 80: Nitrite | 0 | - |
| Week 0: Protein urine | 76 | - |
| Week 0: Protein urine | 1 | - |
| Week 0: Protein urine | 0 | - |
| Week 54: Protein urine | 61 | - |
| Week 54: Protein urine | 4 | - |
| Week 54: Protein urine | 0 | - |
| Week 80: Protein urine | 59 | - |
| Week 80: Protein urine | 2 | - |
| Week 80: Protein urine | 1 | - |
| Week 0: Specific Gravity | 75 | - |
| Week 0: Specific Gravity | 2 | - |
| Week 0: Specific Gravity | 0 | - |
| Week 54: Specific Gravity | 64 | - |
| Week 54: Specific Gravity | 1 | - |
| Week 54: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 62 | - |
| Week 80: Specific Gravity | 0 | - |
| Week 80: Specific Gravity | 0 | - |
Secondary/registry result
Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
Time frame:(Week 0, week 54) and (week 0, week 80)
Thyroid event
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of Thyroid Stimulating Hormone | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 1.04 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 1.12 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.89 | - |
| Change from week 0 to week 80 | 0.99 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.91 | - |
| Change from week 0 to week 80 | 0.93 | - |
Secondary/registry result
Change in Hormone Level: Calcitonin
Time frame:(Week 0, week 54) and (week 0, week 80)
Thyroid event
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of Calcitonin | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | 1.00 | - |
| Change from week 0 to week 80 | 0.85 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.90 | - |
| Change from week 0 to week 80 | 0.93 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | 0.89 | - |
| Change from week 0 to week 80 | 0.82 | - |
| Placebo (Placebo)Change from week 0 to week 54 | 0.88 | - |
| Change from week 0 to week 80 | 0.90 | - |
Secondary/registry result
Change in Body Temperature
Time frame:Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Posted result
| Group | Mean · Degree celsius (C) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Change from week 0 to week 54 | -0.1 | - |
| Change from week 0 to week 80 | -0.0 | - |
| NNC0114-0006 (Experimental)Change from week 0 to week 54 | 0.0 | - |
| Change from week 0 to week 80 | 0.1 | - |
| Liraglutide (Experimental)Change from week 0 to week 54 | -0.1 | - |
| Change from week 0 to week 80 | 0.0 | - |
| Placebo (Placebo)Change from week 0 to week 54 | -0.0 | - |
| Change from week 0 to week 80 | 0.0 | - |
Secondary/registry result
Change in Electrocardiogram (ECG)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 62 | - |
| Week 0 | 15 | - |
| Week 0 | 0 | - |
| Week 54 | 54 | - |
| Week 54 | 14 | - |
| Week 54 | 0 | - |
| Week 80 | 51 | - |
| Week 80 | 15 | - |
| Week 80 | 0 | - |
| NNC0114-0006 (Experimental)Week 0 | 65 | - |
| Week 0 | 12 | - |
| Week 0 | 0 | - |
| Week 54 | 48 | - |
| Week 54 | 17 | - |
| Week 54 | 0 | - |
| Week 80 | 48 | - |
| Week 80 | 16 | - |
| Week 80 | 0 | - |
| Liraglutide (Experimental)Week 0 | 60 | - |
| Week 0 | 16 | - |
| Week 0 | 0 | - |
| Week 54 | 55 | - |
| Week 54 | 12 | - |
| Week 54 | 0 | - |
| Week 80 | 53 | - |
| Week 80 | 15 | - |
| Week 80 | 0 | - |
| Placebo (Placebo)Week 0 | 63 | - |
| Week 0 | 13 | - |
| Week 0 | 1 | - |
| Week 54 | 46 | - |
| Week 54 | 19 | - |
| Week 54 | 0 | - |
| Week 80 | 50 | - |
| Week 80 | 12 | - |
| Week 80 | 0 | - |
Secondary/registry result
Change in Physical Examination
Time frame:Week 0, week 54 and week 80
descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: General Appearance | 76 | - |
| Week 0: General Appearance | 1 | - |
| Week 0: General Appearance | 0 | - |
| Week 54: General Appearance | 68 | - |
| Week 54: General Appearance | 0 | - |
| Week 54: General Appearance | 0 | - |
| Week 80: General Appearance | 67 | - |
| Week 80: General Appearance | 0 | - |
| Week 80: General Appearance | 0 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 75 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 2 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 66 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 1 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 1 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 65 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 2 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 0: Respiratory System | 77 | - |
| Week 0: Respiratory System | 0 | - |
| Week 0: Respiratory System | 0 | - |
| Week 54: Respiratory System | 68 | - |
| Week 54: Respiratory System | 0 | - |
| Week 54: Respiratory System | 0 | - |
| Week 80: Respiratory System | 67 | - |
| Week 80: Respiratory System | 0 | - |
| Week 80: Respiratory System | 0 | - |
| Week 0: Cardiovascular System | 74 | - |
| Week 0: Cardiovascular System | 3 | - |
| Week 0: Cardiovascular System | 0 | - |
| Week 54: Cardiovascular System | 67 | - |
| Week 54: Cardiovascular System | 1 | - |
| Week 54: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 67 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 0: Gastrointestinal System incl. Mouth | 75 | - |
| Week 0: Gastrointestinal System incl. Mouth | 2 | - |
| Week 0: Gastrointestinal System incl. Mouth | 0 | - |
| Week 54: Gastrointestinal System incl. Mouth | 68 | - |
| Week 54: Gastrointestinal System incl. Mouth | 0 | - |
| Week 54: Gastrointestinal System incl. Mouth | 0 | - |
| Week 80: Gastrointestinal System incl. Mouth | 67 | - |
| Week 80: Gastrointestinal System incl. Mouth | 0 | - |
| Week 80: Gastrointestinal System incl. Mouth | 0 | - |
| Week 0: Musculoskeletal System | 76 | - |
| Week 0: Musculoskeletal System | 1 | - |
| Week 0: Musculoskeletal System | 0 | - |
| Week 54: Musculoskeletal System | 65 | - |
| Week 54: Musculoskeletal System | 1 | - |
| Week 54: Musculoskeletal System | 2 | - |
| Week 80: Musculoskeletal System | 66 | - |
| Week 80: Musculoskeletal System | 1 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 0: Central and Peripheral Nervous System | 77 | - |
| Week 0: Central and Peripheral Nervous System | 0 | - |
| Week 0: Central and Peripheral Nervous System | 0 | - |
| Week 54: Central and Peripheral Nervous System | 68 | - |
| Week 54: Central and Peripheral Nervous System | 0 | - |
| Week 54: Central and Peripheral Nervous System | 0 | - |
| Week 80: Central and Peripheral Nervous System | 66 | - |
| Week 80: Central and Peripheral Nervous System | 1 | - |
| Week 80: Central and Peripheral Nervous System | 0 | - |
| Week 0: Skin | 70 | - |
| Week 0: Skin | 6 | - |
| Week 0: Skin | 1 | - |
| Week 54: Skin | 61 | - |
| Week 54: Skin | 5 | - |
| Week 54: Skin | 2 | - |
| Week 80: Skin | 61 | - |
| Week 80: Skin | 6 | - |
| Week 80: Skin | 0 | - |
| Week 0: Lymph Node Palpation | 77 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 68 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 67 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 0: Thyroid Gland | 77 | - |
| Week 0: Thyroid Gland | 0 | - |
| Week 0: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 67 | - |
| Week 54: Thyroid Gland | 1 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 67 | - |
| Week 80: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 0 | - |
| NNC0114-0006 (Experimental)Week 0: General Appearance | 77 | - |
| Week 0: General Appearance | 0 | - |
| Week 0: General Appearance | 0 | - |
| Week 54: General Appearance | 64 | - |
| Week 54: General Appearance | 0 | - |
| Week 54: General Appearance | 1 | - |
| Week 80: General Appearance | 64 | - |
| Week 80: General Appearance | 0 | - |
| Week 80: General Appearance | 0 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 77 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 65 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 64 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 0: Respiratory System | 77 | - |
| Week 0: Respiratory System | 0 | - |
| Week 0: Respiratory System | 0 | - |
| Week 54: Respiratory System | 65 | - |
| Week 54: Respiratory System | 0 | - |
| Week 54: Respiratory System | 0 | - |
| Week 80: Respiratory System | 64 | - |
| Week 80: Respiratory System | 0 | - |
| Week 80: Respiratory System | 0 | - |
| Week 0: Cardiovascular System | 76 | - |
| Week 0: Cardiovascular System | 1 | - |
| Week 0: Cardiovascular System | 0 | - |
| Week 54: Cardiovascular System | 65 | - |
| Week 54: Cardiovascular System | 0 | - |
| Week 54: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 64 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 0: Gastrointestinal System incl. Mouth | 76 | - |
| Week 0: Gastrointestinal System incl. Mouth | 1 | - |
| Week 0: Gastrointestinal System incl. Mouth | 0 | - |
| Week 54: Gastrointestinal System incl. Mouth | 64 | - |
| Week 54: Gastrointestinal System incl. Mouth | 1 | - |
| Week 54: Gastrointestinal System incl. Mouth | 0 | - |
| Week 80: Gastrointestinal System incl. Mouth | 63 | - |
| Week 80: Gastrointestinal System incl. Mouth | 1 | - |
| Week 80: Gastrointestinal System incl. Mouth | 0 | - |
| Week 0: Musculoskeletal System | 75 | - |
| Week 0: Musculoskeletal System | 2 | - |
| Week 0: Musculoskeletal System | 0 | - |
| Week 54: Musculoskeletal System | 63 | - |
| Week 54: Musculoskeletal System | 2 | - |
| Week 54: Musculoskeletal System | 0 | - |
| Week 80: Musculoskeletal System | 64 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 0: Central and Peripheral Nervous System | 76 | - |
| Week 0: Central and Peripheral Nervous System | 1 | - |
| Week 0: Central and Peripheral Nervous System | 0 | - |
| Week 54: Central and Peripheral Nervous System | 64 | - |
| Week 54: Central and Peripheral Nervous System | 1 | - |
| Week 54: Central and Peripheral Nervous System | 0 | - |
| Week 80: Central and Peripheral Nervous System | 63 | - |
| Week 80: Central and Peripheral Nervous System | 1 | - |
| Week 80: Central and Peripheral Nervous System | 0 | - |
| Week 0: Skin | 75 | - |
| Week 0: Skin | 2 | - |
| Week 0: Skin | 0 | - |
| Week 54: Skin | 63 | - |
| Week 54: Skin | 1 | - |
| Week 54: Skin | 1 | - |
| Week 80: Skin | 62 | - |
| Week 80: Skin | 2 | - |
| Week 80: Skin | 0 | - |
| Week 0: Lymph Node Palpation | 76 | - |
| Week 0: Lymph Node Palpation | 1 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 65 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 63 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 0: Thyroid Gland | 76 | - |
| Week 0: Thyroid Gland | 1 | - |
| Week 0: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 65 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 64 | - |
| Week 80: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 0 | - |
| Liraglutide (Experimental)Week 0: General Appearance | 76 | - |
| Week 0: General Appearance | 0 | - |
| Week 0: General Appearance | 0 | - |
| Week 54: General Appearance | 66 | - |
| Week 54: General Appearance | 0 | - |
| Week 54: General Appearance | 0 | - |
| Week 80: General Appearance | 68 | - |
| Week 80: General Appearance | 0 | - |
| Week 80: General Appearance | 0 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 76 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 66 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 66 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 2 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 0: Respiratory System | 76 | - |
| Week 0: Respiratory System | 0 | - |
| Week 0: Respiratory System | 0 | - |
| Week 54: Respiratory System | 66 | - |
| Week 54: Respiratory System | 0 | - |
| Week 54: Respiratory System | 0 | - |
| Week 80: Respiratory System | 68 | - |
| Week 80: Respiratory System | 0 | - |
| Week 80: Respiratory System | 0 | - |
| Week 0: Cardiovascular System | 76 | - |
| Week 0: Cardiovascular System | 0 | - |
| Week 0: Cardiovascular System | 0 | - |
| Week 54: Cardiovascular System | 65 | - |
| Week 54: Cardiovascular System | 1 | - |
| Week 54: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 67 | - |
| Week 80: Cardiovascular System | 1 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 0: Gastrointestinal System incl. Mouth | 76 | - |
| Week 0: Gastrointestinal System incl. Mouth | 0 | - |
| Week 0: Gastrointestinal System incl. Mouth | 0 | - |
| Week 54: Gastrointestinal System incl. Mouth | 66 | - |
| Week 54: Gastrointestinal System incl. Mouth | 0 | - |
| Week 54: Gastrointestinal System incl. Mouth | 0 | - |
| Week 80: Gastrointestinal System incl. Mouth | 68 | - |
| Week 80: Gastrointestinal System incl. Mouth | 0 | - |
| Week 80: Gastrointestinal System incl. Mouth | 0 | - |
| Week 0: Musculoskeletal System | 74 | - |
| Week 0: Musculoskeletal System | 2 | - |
| Week 0: Musculoskeletal System | 0 | - |
| Week 54: Musculoskeletal System | 66 | - |
| Week 54: Musculoskeletal System | 0 | - |
| Week 54: Musculoskeletal System | 0 | - |
| Week 80: Musculoskeletal System | 68 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 0: Central and Peripheral Nervous System | 76 | - |
| Week 0: Central and Peripheral Nervous System | 0 | - |
| Week 0: Central and Peripheral Nervous System | 0 | - |
| Week 54: Central and Peripheral Nervous System | 66 | - |
| Week 54: Central and Peripheral Nervous System | 0 | - |
| Week 54: Central and Peripheral Nervous System | 0 | - |
| Week 80: Central and Peripheral Nervous System | 68 | - |
| Week 80: Central and Peripheral Nervous System | 0 | - |
| Week 80: Central and Peripheral Nervous System | 0 | - |
| Week 0: Skin | 69 | - |
| Week 0: Skin | 7 | - |
| Week 0: Skin | 0 | - |
| Week 54: Skin | 63 | - |
| Week 54: Skin | 3 | - |
| Week 54: Skin | 0 | - |
| Week 80: Skin | 65 | - |
| Week 80: Skin | 3 | - |
| Week 80: Skin | 0 | - |
| Week 0: Lymph Node Palpation | 76 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 66 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 67 | - |
| Week 80: Lymph Node Palpation | 1 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 0: Thyroid Gland | 76 | - |
| Week 0: Thyroid Gland | 0 | - |
| Week 0: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 66 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 68 | - |
| Week 80: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 0 | - |
| Placebo (Placebo)Week 0: General Appearance | 76 | - |
| Week 0: General Appearance | 1 | - |
| Week 0: General Appearance | 0 | - |
| Week 54: General Appearance | 65 | - |
| Week 54: General Appearance | 1 | - |
| Week 54: General Appearance | 0 | - |
| Week 80: General Appearance | 61 | - |
| Week 80: General Appearance | 1 | - |
| Week 80: General Appearance | 0 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 76 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 1 | - |
| Week 0: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 66 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 54: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 60 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 2 | - |
| Week 80: Head, Ears, Eyes, Nose, Throat, Neck | 0 | - |
| Week 0: Respiratory System | 77 | - |
| Week 0: Respiratory System | 0 | - |
| Week 0: Respiratory System | 0 | - |
| Week 54: Respiratory System | 66 | - |
| Week 54: Respiratory System | 0 | - |
| Week 54: Respiratory System | 0 | - |
| Week 80: Respiratory System | 61 | - |
| Week 80: Respiratory System | 1 | - |
| Week 80: Respiratory System | 0 | - |
| Week 0: Cardiovascular System | 73 | - |
| Week 0: Cardiovascular System | 4 | - |
| Week 0: Cardiovascular System | 0 | - |
| Week 54: Cardiovascular System | 66 | - |
| Week 54: Cardiovascular System | 0 | - |
| Week 54: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 62 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 80: Cardiovascular System | 0 | - |
| Week 0: Gastrointestinal System incl. Mouth | 76 | - |
| Week 0: Gastrointestinal System incl. Mouth | 1 | - |
| Week 0: Gastrointestinal System incl. Mouth | 0 | - |
| Week 54: Gastrointestinal System incl. Mouth | 65 | - |
| Week 54: Gastrointestinal System incl. Mouth | 1 | - |
| Week 54: Gastrointestinal System incl. Mouth | 0 | - |
| Week 80: Gastrointestinal System incl. Mouth | 61 | - |
| Week 80: Gastrointestinal System incl. Mouth | 1 | - |
| Week 80: Gastrointestinal System incl. Mouth | 0 | - |
| Week 0: Musculoskeletal System | 77 | - |
| Week 0: Musculoskeletal System | 0 | - |
| Week 0: Musculoskeletal System | 0 | - |
| Week 54: Musculoskeletal System | 65 | - |
| Week 54: Musculoskeletal System | 1 | - |
| Week 54: Musculoskeletal System | 0 | - |
| Week 80: Musculoskeletal System | 62 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 80: Musculoskeletal System | 0 | - |
| Week 0: Central and Peripheral Nervous System | 76 | - |
| Week 0: Central and Peripheral Nervous System | 1 | - |
| Week 0: Central and Peripheral Nervous System | 0 | - |
| Week 54: Central and Peripheral Nervous System | 65 | - |
| Week 54: Central and Peripheral Nervous System | 1 | - |
| Week 54: Central and Peripheral Nervous System | 0 | - |
| Week 80: Central and Peripheral Nervous System | 62 | - |
| Week 80: Central and Peripheral Nervous System | 0 | - |
| Week 80: Central and Peripheral Nervous System | 0 | - |
| Week 0: Skin | 74 | - |
| Week 0: Skin | 3 | - |
| Week 0: Skin | 0 | - |
| Week 54: Skin | 66 | - |
| Week 54: Skin | 0 | - |
| Week 54: Skin | 0 | - |
| Week 80: Skin | 62 | - |
| Week 80: Skin | 0 | - |
| Week 80: Skin | 0 | - |
| Week 0: Lymph Node Palpation | 77 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 0: Lymph Node Palpation | 0 | - |
| Week 54: Lymph Node Palpation | 64 | - |
| Week 54: Lymph Node Palpation | 1 | - |
| Week 54: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 62 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 80: Lymph Node Palpation | 0 | - |
| Week 0: Thyroid Gland | 75 | - |
| Week 0: Thyroid Gland | 2 | - |
| Week 0: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 65 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 54: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 62 | - |
| Week 80: Thyroid Gland | 0 | - |
| Week 80: Thyroid Gland | 0 | - |
Secondary/registry result
Occurrence of Anti-NNC0114-0006 Antibodies
Time frame:Week 0, week 54 and week 80
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Anti-NNC0114-0006 antibodies | 68 | - |
| Week 0: Anti-NNC0114-0006 antibodies | 9 | - |
| Week 0: Cross-reactivity | 4 | - |
| Week 0: Cross-reactivity | 5 | - |
| Week 54: Anti-NNC0114-0006 | 68 | - |
| Week 54: Anti-NNC0114-0006 | 0 | - |
| Week 54: Cross-reactivity | 0 | - |
| Week 54: Cross-reactivity | 0 | - |
| Week 80: Anti-NNC0114-0006 antibodies | 65 | - |
| Week 80: Anti-NNC0114-0006 antibodies | 2 | - |
| Week 80: Cross-reactivity | 1 | - |
| Week 80: Cross-reactivity | 1 | - |
| NNC0114-0006 (Experimental)Week 0: Anti-NNC0114-0006 antibodies | 62 | - |
| Week 0: Anti-NNC0114-0006 antibodies | 14 | - |
| Week 0: Cross-reactivity | 7 | - |
| Week 0: Cross-reactivity | 7 | - |
| Week 54: Anti-NNC0114-0006 | 62 | - |
| Week 54: Anti-NNC0114-0006 | 3 | - |
| Week 54: Cross-reactivity | 3 | - |
| Week 54: Cross-reactivity | 0 | - |
| Week 80: Anti-NNC0114-0006 antibodies | 60 | - |
| Week 80: Anti-NNC0114-0006 antibodies | 4 | - |
| Week 80: Cross-reactivity | 2 | - |
| Week 80: Cross-reactivity | 2 | - |
Secondary/registry result
Occurrence of Anti-liraglutide Antibodies
Time frame:Week 0, week 54 and week 80
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Anti-Liraglutide antibodies | 77 | - |
| Week 0: Anti-Liraglutide antibodies | 0 | - |
| Week 0: Cross-reactivity to native GLP-1 | 0 | - |
| Week 0: Cross-reactivity to native GLP-1 | 0 | - |
| Week 54: Anti-Liraglutide antibodies | 67 | - |
| Week 54: Anti-Liraglutide antibodies | 1 | - |
| Week 54: Cross-reactivity to native GLP-1 | 1 | - |
| Week 54: Cross-reactivity to native GLP-1 | 0 | - |
| Week 80: Anti-Liraglutide antibodies | 67 | - |
| Week 80: Anti-Liraglutide antibodies | 0 | - |
| Week 80: Cross-reactivity to native GLP-1 | 0 | - |
| Week 80: Cross-reactivity to native GLP-1 | 0 | - |
| Liraglutide (Experimental)Week 0: Anti-Liraglutide antibodies | 75 | - |
| Week 0: Anti-Liraglutide antibodies | 0 | - |
| Week 0: Cross-reactivity to native GLP-1 | 0 | - |
| Week 0: Cross-reactivity to native GLP-1 | 0 | - |
| Week 54: Anti-Liraglutide antibodies | 65 | - |
| Week 54: Anti-Liraglutide antibodies | 2 | - |
| Week 54: Cross-reactivity to native GLP-1 | 1 | - |
| Week 54: Cross-reactivity to native GLP-1 | 1 | - |
| Week 80: Anti-Liraglutide antibodies | 66 | - |
| Week 80: Anti-Liraglutide antibodies | 2 | - |
| Week 80: Cross-reactivity to native GLP-1 | 0 | - |
| Week 80: Cross-reactivity to native GLP-1 | 0 | - |
Secondary/registry result
Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 54
AUC₀-∞
concentration, descriptive
Posted result
| Group | Geometric mean · day*microgram per milliliter (day*ug/mL) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 3969 | - |
| NNC0114-0006 (Experimental) | 4115 | - |
Secondary/registry result
Terminal Half-life (t½) After Last Dose of NNC0114-0006
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 80
Half-life
descriptive
Posted result
| Group | Geometric mean · Days | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 22.3 | - |
| NNC0114-0006 (Experimental) | 22.2 | - |
Secondary/registry result
Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 80
descriptive
Posted result
| Group | Geometric mean · Milliliters per kilogram (mL/kg) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 83.7 | - |
| NNC0114-0006 (Experimental) | 79.3 | - |
Secondary/registry result
Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 54
descriptive
Posted result
| Group | Geometric mean · (Milliliters/day)/kilogram ([mL/day]/kg) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 3.02 | - |
| NNC0114-0006 (Experimental) | 2.92 | - |
Secondary/registry result
Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 80
descriptive
Posted result
| Group | Geometric mean · Days | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 27.7 | - |
| NNC0114-0006 (Experimental) | 27.2 | - |
Secondary/registry result
Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)
ratio, descriptive
Posted result
| Group | Geometric mean · Ratio of AUC | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 1.24 | - |
| NNC0114-0006 (Experimental) | 1.26 | - |
Secondary/registry result
Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
Time frame:Week 48 (predose)
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Geometric mean · microgram/milliliter (ug/mL) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 34.7 | - |
| NNC0114-0006 (Experimental) | 36.7 | - |
Secondary/registry result
Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
Time frame:Week 48 (1 hour post-dose)
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Geometric mean · ug/mL | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 298.6 | - |
| NNC0114-0006 (Experimental) | 282.6 | - |
Secondary/registry result
Liraglutide Concentration at Steady State (C Liraglutide)
Time frame:Week 54 (post-dose)
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Geometric mean · picomole per liter (pmol/L) | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental) | 16287 | - |
| Liraglutide (Experimental) | 15920 | - |
Secondary/registry result
Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 3 | - |
| Week 0 | 74 | - |
| Week 54 | 5 | - |
| Week 54 | 62 | - |
| Week 80 | 4 | - |
| Week 80 | 61 | - |
| NNC0114-0006 (Experimental)Week 0 | 1 | - |
| Week 0 | 76 | - |
| Week 54 | 4 | - |
| Week 54 | 61 | - |
| Week 80 | 2 | - |
| Week 80 | 62 | - |
| Liraglutide (Experimental)Week 0 | 5 | - |
| Week 0 | 71 | - |
| Week 54 | 4 | - |
| Week 54 | 64 | - |
| Week 80 | 5 | - |
| Week 80 | 63 | - |
| Placebo (Placebo)Week 0 | 3 | - |
| Week 0 | 74 | - |
| Week 54 | 3 | - |
| Week 54 | 63 | - |
| Week 80 | 1 | - |
| Week 80 | 61 | - |
Secondary/registry result
Autoantibodies Against Zinc-transporter 8 (ZnT8)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 29 | - |
| Week 0 | 48 | - |
| Week 54 | 26 | - |
| Week 54 | 42 | - |
| Week 80 | 23 | - |
| Week 80 | 42 | - |
| NNC0114-0006 (Experimental)Week 0 | 30 | - |
| Week 0 | 47 | - |
| Week 54 | 28 | - |
| Week 54 | 37 | - |
| Week 80 | 30 | - |
| Week 80 | 34 | - |
| Liraglutide (Experimental)Week 0 | 30 | - |
| Week 0 | 46 | - |
| Week 54 | 27 | - |
| Week 54 | 41 | - |
| Week 80 | 31 | - |
| Week 80 | 37 | - |
| Placebo (Placebo)Week 0 | 36 | - |
| Week 0 | 41 | - |
| Week 54 | 33 | - |
| Week 54 | 33 | - |
| Week 80 | 33 | - |
| Week 80 | 29 | - |
Secondary/registry result
Autoantibodies Against Islet Antigen-2 (IA2)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 38 | - |
| Week 0 | 39 | - |
| Week 54 | 35 | - |
| Week 54 | 33 | - |
| Week 80 | 32 | - |
| Week 80 | 33 | - |
| NNC0114-0006 (Experimental)Week 0 | 37 | - |
| Week 0 | 40 | - |
| Week 54 | 33 | - |
| Week 54 | 32 | - |
| Week 80 | 38 | - |
| Week 80 | 26 | - |
| Liraglutide (Experimental)Week 0 | 31 | - |
| Week 0 | 45 | - |
| Week 54 | 28 | - |
| Week 54 | 40 | - |
| Week 80 | 29 | - |
| Week 80 | 39 | - |
| Placebo (Placebo)Week 0 | 45 | - |
| Week 0 | 32 | - |
| Week 54 | 38 | - |
| Week 54 | 28 | - |
| Week 80 | 35 | - |
| Week 80 | 27 | - |
Secondary/registry result
Autoantibodies Against Insulin Autoantibodies (IAA)
Time frame:Week 0, week 54 and week 80
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0 | 35 | - |
| Week 0 | 42 | - |
| Week 54 | 30 | - |
| Week 54 | 38 | - |
| Week 80 | 18 | - |
| Week 80 | 48 | - |
| NNC0114-0006 (Experimental)Week 0 | 28 | - |
| Week 0 | 48 | - |
| Week 54 | 28 | - |
| Week 54 | 37 | - |
| Week 80 | 24 | - |
| Week 80 | 40 | - |
| Liraglutide (Experimental)Week 0 | 26 | - |
| Week 0 | 49 | - |
| Week 54 | 22 | - |
| Week 54 | 46 | - |
| Week 80 | 13 | - |
| Week 80 | 55 | - |
| Placebo (Placebo)Week 0 | 36 | - |
| Week 0 | 40 | - |
| Week 54 | 11 | - |
| Week 54 | 55 | - |
| Week 80 | 15 | - |
| Week 80 | 47 | - |
Secondary/protocol endpoint
Number of Treatment Emergent Adverse Events
Time frame:Week 0-54; Week 54-80
Treatment-emergent AEs (any)
event count, event
Secondary/protocol endpoint
Number of Treatment Emergent Hyperglycaemic Episodes
Time frame:Week 0-54; Week 54-80
event count, event
Secondary/protocol endpoint
Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
Time frame:Weeks 0-54; Weeks 54-80
event count, event
Secondary/protocol endpoint
Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
Time frame:Week 0-54
event count, event
Secondary/protocol endpoint
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
Time frame:Weeks 0-54; Weeks 54-80
Documented hypoglycemia
event count, event
Secondary/protocol endpoint
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
Time frame:Weeks 0-54; Weeks 54-80
Documented hypoglycemia
event count, event
Secondary/protocol endpoint
Change in Haematology: Erythrocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Haematocrit
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Haemoglobin
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Leukocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Mean Corpuscular Hemoglobin
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Thrombocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Eosinophil
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Neutrophils
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Basophils
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Lymphocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Haematology: Monocytes
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Biochemistry: Amylase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Biochemistry: Calcium Corrected
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Biochemistry: Creatine Kinase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Biochemistry: Lipase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Biochemistry: Potassium
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Total Immunoglobulin E (IgE)
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint
Change in Urinalysis: Urine Dipsticks
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint
Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
Time frame:(Week 0, week 54) and (week 0, week 80)
Thyroid event
ratio, descriptive
Secondary/protocol endpoint
Change in Hormone Level: Calcitonin
Time frame:(Week 0, week 54) and (week 0, week 80)
Thyroid event
ratio, descriptive
Secondary/protocol endpoint
Change in Electrocardiogram (ECG)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint
Change in Physical Examination
Time frame:Week 0, week 54 and week 80
descriptive
Secondary/protocol endpoint
Occurrence of Anti-NNC0114-0006 Antibodies
Time frame:Week 0, week 54 and week 80
Immunogenicity (ADA)
descriptive
Secondary/protocol endpoint
Occurrence of Anti-liraglutide Antibodies
Time frame:Week 0, week 54 and week 80
Immunogenicity (ADA)
threshold achievement, event
Secondary/protocol endpoint
Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 54
AUC₀-∞
concentration, descriptive
Secondary/protocol endpoint
Terminal Half-life (t½) After Last Dose of NNC0114-0006
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 80
Half-life
descriptive
Secondary/protocol endpoint
Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 80
descriptive
Secondary/protocol endpoint
Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 54
descriptive
Secondary/protocol endpoint
Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during week 48 to week 80
descriptive
Secondary/protocol endpoint
Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
Time frame:Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)
ratio, descriptive
Secondary/protocol endpoint
Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
Time frame:Week 48 (predose)
Plasma concentration (steady state)
concentration, descriptive
Secondary/protocol endpoint
Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
Time frame:Week 48 (1 hour post-dose)
Plasma concentration (steady state)
concentration, descriptive
Secondary/protocol endpoint
Liraglutide Concentration at Steady State (C Liraglutide)
Time frame:Week 54 (post-dose)
Plasma concentration (steady state)
concentration, descriptive
Secondary/protocol endpoint
Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint
Autoantibodies Against Zinc-transporter 8 (ZnT8)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint
Autoantibodies Against Islet Antigen-2 (IA2)
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint
Autoantibodies Against Insulin Autoantibodies (IAA)
Time frame:Week 0, week 54 and week 80
Immunogenicity (ADA)
categorical status, event
Other clinical outcomes
5 endpointsSecondary/registry result
Diabetes Retinopathy
Time frame:Baseline, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Baseline (Day:-28 to -14) | 4 | - |
| Baseline (Day:-28 to -14) | 73 | - |
| Baseline (Day:-28 to -14) | 0 | - |
| Week 54 | 3 | - |
| Week 54 | 65 | - |
| Week 54 | 0 | - |
| Week 80 | 3 | - |
| Week 80 | 65 | - |
| Week 80 | 1 | - |
| NNC0114-0006 (Experimental)Baseline (Day:-28 to -14) | 2 | - |
| Baseline (Day:-28 to -14) | 75 | - |
| Baseline (Day:-28 to -14) | 0 | - |
| Week 54 | 2 | - |
| Week 54 | 63 | - |
| Week 54 | 0 | - |
| Week 80 | 2 | - |
| Week 80 | 62 | - |
| Week 80 | 1 | - |
| Liraglutide (Experimental)Baseline (Day:-28 to -14) | 1 | - |
| Baseline (Day:-28 to -14) | 75 | - |
| Baseline (Day:-28 to -14) | 0 | - |
| Week 54 | 1 | - |
| Week 54 | 68 | - |
| Week 54 | 0 | - |
| Week 80 | 1 | - |
| Week 80 | 67 | - |
| Week 80 | 1 | - |
| Placebo (Placebo)Baseline (Day:-28 to -14) | 1 | - |
| Baseline (Day:-28 to -14) | 76 | - |
| Baseline (Day:-28 to -14) | 0 | - |
| Week 54 | 0 | - |
| Week 54 | 68 | - |
| Week 54 | 0 | - |
| Week 80 | 0 | - |
| Week 80 | 63 | - |
| Week 80 | 1 | - |
Secondary/registry result
Change in Eye-examination
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| NNC0114-0006 + Liraglutide (Experimental)Week 0: Left eye ophthalmoscopy | 64 | - |
| Week 0: Left eye ophthalmoscopy | 13 | - |
| Week 0: Left eye ophthalmoscopy | 0 | - |
| Week 54: Left eye ophthalmoscopy | 55 | - |
| Week 54: Left eye ophthalmoscopy | 12 | - |
| Week 54: Left eye ophthalmoscopy | 1 | - |
| Week 80: Left eye ophthalmoscopy | 52 | - |
| Week 80: Left eye ophthalmoscopy | 11 | - |
| Week 80: Left eye ophthalmoscopy | 3 | - |
| Week 0: Right eye ophthalmoscopy | 58 | - |
| Week 0: Right eye ophthalmoscopy | 18 | - |
| Week 0: Right eye ophthalmoscopy | 1 | - |
| Week 54: Right eye ophthalmoscopy | 55 | - |
| Week 54: Right eye ophthalmoscopy | 13 | - |
| Week 54: Right eye ophthalmoscopy | 0 | - |
| Week 80: Right eye ophthalmoscopy | 52 | - |
| Week 80: Right eye ophthalmoscopy | 12 | - |
| Week 80: Right eye ophthalmoscopy | 2 | - |
| NNC0114-0006 (Experimental)Week 0: Left eye ophthalmoscopy | 68 | - |
| Week 0: Left eye ophthalmoscopy | 9 | - |
| Week 0: Left eye ophthalmoscopy | 0 | - |
| Week 54: Left eye ophthalmoscopy | 56 | - |
| Week 54: Left eye ophthalmoscopy | 7 | - |
| Week 54: Left eye ophthalmoscopy | 0 | - |
| Week 80: Left eye ophthalmoscopy | 54 | - |
| Week 80: Left eye ophthalmoscopy | 8 | - |
| Week 80: Left eye ophthalmoscopy | 0 | - |
| Week 0: Right eye ophthalmoscopy | 66 | - |
| Week 0: Right eye ophthalmoscopy | 11 | - |
| Week 0: Right eye ophthalmoscopy | 0 | - |
| Week 54: Right eye ophthalmoscopy | 55 | - |
| Week 54: Right eye ophthalmoscopy | 8 | - |
| Week 54: Right eye ophthalmoscopy | 0 | - |
| Week 80: Right eye ophthalmoscopy | 53 | - |
| Week 80: Right eye ophthalmoscopy | 9 | - |
| Week 80: Right eye ophthalmoscopy | 0 | - |
| Liraglutide (Experimental)Week 0: Left eye ophthalmoscopy | 70 | - |
| Week 0: Left eye ophthalmoscopy | 6 | - |
| Week 0: Left eye ophthalmoscopy | 0 | - |
| Week 54: Left eye ophthalmoscopy | 60 | - |
| Week 54: Left eye ophthalmoscopy | 9 | - |
| Week 54: Left eye ophthalmoscopy | 0 | - |
| Week 80: Left eye ophthalmoscopy | 59 | - |
| Week 80: Left eye ophthalmoscopy | 6 | - |
| Week 80: Left eye ophthalmoscopy | 0 | - |
| Week 0: Right eye ophthalmoscopy | 69 | - |
| Week 0: Right eye ophthalmoscopy | 7 | - |
| Week 0: Right eye ophthalmoscopy | 0 | - |
| Week 54: Right eye ophthalmoscopy | 60 | - |
| Week 54: Right eye ophthalmoscopy | 9 | - |
| Week 54: Right eye ophthalmoscopy | 0 | - |
| Week 80: Right eye ophthalmoscopy | 58 | - |
| Week 80: Right eye ophthalmoscopy | 7 | - |
| Week 80: Right eye ophthalmoscopy | 0 | - |
| Placebo (Placebo)Week 0: Left eye ophthalmoscopy | 66 | - |
| Week 0: Left eye ophthalmoscopy | 11 | - |
| Week 0: Left eye ophthalmoscopy | 0 | - |
| Week 54: Left eye ophthalmoscopy | 54 | - |
| Week 54: Left eye ophthalmoscopy | 9 | - |
| Week 54: Left eye ophthalmoscopy | 1 | - |
| Week 80: Left eye ophthalmoscopy | 51 | - |
| Week 80: Left eye ophthalmoscopy | 8 | - |
| Week 80: Left eye ophthalmoscopy | 0 | - |
| Week 0: Right eye ophthalmoscopy | 67 | - |
| Week 0: Right eye ophthalmoscopy | 10 | - |
| Week 0: Right eye ophthalmoscopy | 0 | - |
| Week 54: Right eye ophthalmoscopy | 55 | - |
| Week 54: Right eye ophthalmoscopy | 8 | - |
| Week 54: Right eye ophthalmoscopy | 1 | - |
| Week 80: Right eye ophthalmoscopy | 51 | - |
| Week 80: Right eye ophthalmoscopy | 8 | - |
| Week 80: Right eye ophthalmoscopy | 0 | - |
Secondary/protocol endpoint
Diabetes Retinopathy
Time frame:Baseline, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint
Change in Eye-examination
Time frame:Week 0, week 54 and week 80
categorical status, descriptive
Secondary/protocol endpoint/low confidence
Number of Weeks Off Bolus Insulin
Time frame:(Week 0 to week 54) and (week 0 to week 80)
descriptive, improvement
Other (unclassified)
25 endpointsSecondary/protocol endpoint/low confidence
Change in Haematology: Mean Corpuscular Hemoglobin Concentration
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Haematology: Mean Corpuscular Volume
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Albumin
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Alkaline Phosphatase (ALP)
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Chloride
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Lactate Dehydrogenase
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Phosphate
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Sodium
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Biochemistry: Total Protein
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in International Normalised Ratio (INR)
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, descriptive
Secondary/protocol endpoint/low confidence
Change in Cytokines: Interleukin (IL)-6
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Change in Cytokines- Interleukin (IL)-10
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Change in Cytokines: Interleukin (IL)-17
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Change in Cytokines: Interferon (IFN) Gamma
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Change in Cytokines: TNF-alpha
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Change in Body Temperature
Time frame:Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Respiratory Rate
Time frame:(Week 0, week 54) and (week 0, week 80)
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Fasting Glucagon- Ratio to Baseline
Time frame:(Week 0, week 54) and (week 0, week 80)
ratio, improvement
Secondary/protocol endpoint/low confidence
Change in Biomarker: Immune Phenotyping- B Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Biomarker: Immune Phenotyping- T Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Secondary/protocol endpoint/low confidence
Change in Biomarker: Total Interleukin-21 (IL-21)
Time frame:Week 0, week 54 and week 80
change from baseline, improvement
Secondary/protocol endpoint/low confidence
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
Time frame:Week 0, week 54 and week 80
change from baseline, descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The lancet. Diabetes & endocrinology2021 Apr (month)PMID33662334doi:10.1016/S2213-8587(21)00019-Xvia CT.gov reference + pubmed nct search
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.