DUAL™ VIII

CompletedPhase 3Results posted

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

143

Recruiting sites

—

Enrollment

1,012

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c 7-11%

Primary endpoint

•HbA1c <7.0% achievement

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02501161

Org study IDNN9068-4228

Secondary ID2014-005639-15

Secondary IDU1111-1165-3914WHO

Timeline

Milestones

Study first posted2015-07-17estimated

Study start2016-01-31actual

Primary completion2018-10-03actual

Study completion2018-10-03actual

Last update posted2019-11-27actual

Results first posted2019-11-27actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age greater than or equal to 18 years at the time of signing informed consent

•Subjects diagnosed with type 2 diabetes mellitus

•HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis

•Body mass index greater than or equal to 20 kg/m^2

•Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

•Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening:

a)Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record),

b)Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)

Exclusion criteria

•Screening calcitonin greater than or equal to 50 ng/L

•Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening

•Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal

•Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma

•History of pancreatitis (acute or chronic)

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening

•Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Endpoints (108)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

Renal / kidney

Other clinical outcomes

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 26, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Insulin Degludec/LiraglutideWeek 26	0.5	—
Week 104	1.2	—
Insulin GlargineWeek 26	2.2	—
Week 104	3.0	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 26, week 104

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

36 endpoints

Primary/registry result

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

Time frame:Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Posted result

Group	Value (median), Weeks	95% CI
Insulin Degludec/LiraglutideBaseline HbA1c <8.5% + Non-SU users	NA	104.0 – NA
Baseline HbA1c <8.5% + SU users	106.7	89.9 – NA
Baseline HbA1c >=8.5% + Non-SU users	NA	39.7 – NA
Baseline HbA1c >=8.5% + SU users	104.0	26.4 – NA
Insulin GlargineBaseline HbA1c <8.5% + Non-SU users	104.3	38.1 – NA
Baseline HbA1c <8.5% + SU users	90.3	26.4 – 105.1
Baseline HbA1c >=8.5% + Non-SU users	64.6	26.1 – 105.1
Baseline HbA1c >=8.5% + SU users	26.6	26.1 – 91.1

p<.0001Stratified log-rank test

Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.

Primary/protocol endpoint

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

Time frame:Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Secondary/registry result

Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits

Time frame:Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

HbA1c <6.5% achievement

time to event, event

LOINC 4548-4

Posted result

Group	Value (median), Weeks	95% CI
Insulin Degludec/LiraglutideBaseline HbA1c <8.5% + Non-SU users	NA	52.1 – NA
Baseline HbA1c <8.5% + SU users	90.1	27.0 – NA
Baseline HbA1c >=8.5% + Non-SU users	64.1	26.1 – NA
Baseline HbA1c >=8.5% + SU users	52.1	26.1 – 104.1
Insulin GlargineBaseline HbA1c <8.5% + Non-SU users	64.1	26.1 – 104.3
Baseline HbA1c <8.5% + SU users	26.6	26.1 – 89.9
Baseline HbA1c >=8.5% + Non-SU users	26.6	26.1 – 90.1
Baseline HbA1c >=8.5% + SU users	26.1	26.1 – 38.1

p<.0001Stratified log-rank test

Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.

Secondary/registry result

Change in HbA1c

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Insulin Degludec/Liraglutide	-1.99	—
Insulin Glargine	-1.69	—

Secondary/registry result/low confidence

Insulin Dose

Time frame:Week 26, week 104

descriptive

Posted result

Group	Value (mean), Units	95% CI
Insulin Degludec/LiraglutideWeek 26	34.6	—
Week 104	36.1	—
Insulin GlargineWeek 26	48.6	—
Week 104	50.6	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c <7.0%

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	78.7	—
Week 26: No	21.3	—
Week 104: Yes	55.5	—
Week 104: No	44.5	—
Insulin GlargineWeek 26: Yes	55.7	—
Week 26: No	44.3	—
Week 104: Yes	28.5	—
Week 104: No	71.5	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	38.5	—
Week 26: No	61.5	—
Week 104: Yes	20.9	—
Week 104: No	79.1	—
Insulin GlargineWeek 26: Yes	15.4	—
Week 26: No	84.6	—
Week 104: Yes	6.3	—
Week 104: No	93.7	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	71.3	—
Week 26: No	28.7	—
Week 104: Yes	51.8	—
Week 104: No	48.2	—
Insulin GlargineWeek 26: Yes	44.9	—
Week 26: No	55.1	—
Week 104: Yes	25.5	—
Week 104: No	74.5	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	35.2	—
Week 26: No	64.8	—
Week 104: Yes	20.0	—
Week 104: No	80.0	—
Insulin GlargineWeek 26: Yes	13.6	—
Week 26: No	86.4	—
Week 104: Yes	6.1	—
Week 104: No	93.9	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c ≤6.5%

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	63.6	—
Week 26: No	36.4	—
Week 104: Yes	43.3	—
Week 104: No	56.7	—
Insulin GlargineWeek 26: Yes	35.4	—
Week 26: No	64.6	—
Week 104: Yes	21.7	—
Week 104: No	78.3	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	33.2	—
Week 26: No	66.8	—
Week 104: Yes	17.6	—
Week 104: No	82.4	—
Insulin GlargineWeek 26: Yes	9.9	—
Week 26: No	90.1	—
Week 104: Yes	5.7	—
Week 104: No	94.3	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 26, week 104

Expanded / custom MACE composite

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	57.9	—
Week 26: No	42.1	—
Week 104: Yes	40.1	—
Week 104: No	59.9	—
Insulin GlargineWeek 26: Yes	27.9	—
Week 26: No	72.1	—
Week 104: Yes	19.2	—
Week 104: No	80.8	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Insulin Degludec/LiraglutideWeek 26: Yes	30.2	—
Week 26: No	69.8	—
Week 104: Yes	16.6	—
Week 104: No	83.4	—
Insulin GlargineWeek 26: Yes	8.7	—
Week 26: No	91.3	—
Week 104: Yes	5.5	—
Week 104: No	94.5	—

Secondary/registry result

Change in FPG

Time frame:Week 0, week 26, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideWeek 26	-3.97	—
Week 104	-3.93	—
Insulin GlargineWeek 26	-3.79	—
Week 104	-3.73	—

Secondary/registry result

SMPG-9-point Profile (Individual Points in the Profile)

Time frame:Week 26, week 104

descriptive, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideWeek 26: Before breakfast	5.59	—
Week 26: 90 minutes after breakfast	8.34	—
Week 26: Before lunch	6.03	—
Week 26: 90 minutes after lunch	8.02	—
Week 26: Before dinner	6.67	—
Week 26: 90 minutes after dinner	8.31	—
Week 26: Bedtime	7.48	—
Week 26: At 4:00 a.m.	5.72	—
Week 26: Before breakfast the following day	5.53	—
Week 104: Before breakfast	5.58	—
Week 104: 90 minutes after breakfast	7.99	—
Week 104: Before lunch	6.06	—
Week 104: 90 minutes after lunch	7.80	—
Week 104: Before dinner	6.58	—
Week 104: 90 minutes after dinner	8.20	—
Week 104: Bedtime	7.47	—
Week 104: At 4:00 a.m.	5.67	—
Week 104: Before breakfast the following day	5.44	—
Insulin GlargineWeek 26: Before breakfast	5.58	—
Week 26: 90 minutes after breakfast	8.76	—
Week 26: Before lunch	6.43	—
Week 26: 90 minutes after lunch	8.79	—
Week 26: Before dinner	6.91	—
Week 26: 90 minutes after dinner	9.10	—
Week 26: Bedtime	8.13	—
Week 26: At 4:00 a.m.	5.91	—
Week 26: Before breakfast the following day	5.56	—
Week 104: Before breakfast	5.57	—
Week 104: 90 minutes after breakfast	8.64	—
Week 104: Before lunch	6.37	—
Week 104: 90 minutes after lunch	8.87	—
Week 104: Before dinner	7.02	—
Week 104: 90 minutes after dinner	9.10	—
Week 104: Bedtime	7.90	—
Week 104: At 4:00 a.m.	5.96	—
Week 104: Before breakfast the following day	5.47	—

Secondary/registry result

Change in SMPG-mean 9-point Profile

Time frame:Week 0, week 26, week 104

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideWeek 26	-3.34	—
Week 104	-3.27	—
Insulin GlargineWeek 26	-3.32	—
Week 104	-2.76	—

Secondary/registry result

Change in SMPG-mean Postprandial Increment Over All Meals

Time frame:Week 0, week 26, week 104

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideWeek 26	-0.28	—
Week 104	-0.47	—
Insulin GlargineWeek 26	0.20	—
Week 104	0.12	—

Secondary/registry result

Change in Fasting C-peptide

Time frame:Week 0, week 26, week 104

C-peptide AUC

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of C-peptide	95% CI
Insulin Degludec/LiraglutideWeek 26	0.63	—
Week 104	0.58	—
Insulin GlargineWeek 26	0.57	—
Week 104	0.54	—

Secondary/registry result

Change in Fasting Human Insulin

Time frame:Week 0, week 26, week 104

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of insulin	95% CI
Insulin Degludec/LiraglutideWeek 26	0.67	—
Week 104	0.60	—
Insulin GlargineWeek 26	0.68	—
Week 104	0.62	—

Secondary/protocol endpoint

Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits

Time frame:Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

time to event, event

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Insulin Dose

Time frame:Week 26, week 104

descriptive

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c <7.0%

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Time frame:Week 26, week 104

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c ≤6.5%

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

Time frame:Week 26, week 104

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0, week 26, week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

SMPG-9-point Profile (Individual Points in the Profile)

Time frame:Week 26, week 104

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Change in SMPG-mean 9-point Profile

Time frame:Week 0, week 26, week 104

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in SMPG-mean Postprandial Increment Over All Meals

Time frame:Week 0, week 26, week 104

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting C-peptide

Time frame:Week 0, week 26, week 104

ratio, improvement

Secondary/protocol endpoint/low confidence

Change in Fasting Human Insulin

Time frame:Week 0, week 26, week 104

ratio, improvement

Renal / kidney

2 endpoints

Secondary/registry result

Change in Urine Albumin/Creatinine Ratio

Time frame:Week 0, week 104

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (mean), Milligrams per millimole (mg/mmol)	95% CI
Insulin Degludec/Liraglutide	-1.09	—
Insulin Glargine	-0.74	—

Secondary/protocol endpoint

Change in Urine Albumin/Creatinine Ratio

Time frame:Week 0, week 104

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

16 endpoints

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic)

Time frame:Week 0, week 26, week 104

change from baseline, improvement

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Insulin Degludec/LiraglutideWeek 26: Systolic blood pressure	-1.2	—
Week 26: Diastolic blood pressure	0.1	—
Week 104: Systolic blood pressure	0.5	—
Week 104: Diastolic blood pressure	-0.1	—
Insulin GlargineWeek 26: Systolic blood pressure	0.5	—
Week 26: Diastolic blood pressure	-0.3	—
Week 104: Systolic blood pressure	0.9	—
Week 104: Diastolic blood pressure	-0.2	—

Secondary/registry result

Change in Fasting Total Cholesterol

Time frame:Week 0, week 26, week 104

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Insulin Degludec/LiraglutideWeek 26	0.99	—
Week 104	0.97	—
Insulin GlargineWeek 26	0.99	—
Week 104	0.97	—

Secondary/registry result

Change in Fasting LDL-cholesterol

Time frame:Week 0, week 26, week 104

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL-cholesterol	95% CI
Insulin Degludec/LiraglutideWeek 26	1.05	—
Week 104	0.96	—
Insulin GlargineWeek 26	1.02	—
Week 104	0.98	—

Secondary/registry result

Change in Fasting HDL-cholesterol

Time frame:Week 0, week 26, week 104

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL-cholesterol	95% CI
Insulin Degludec/LiraglutideWeek 26	1.03	—
Week 104	1.02	—
Insulin GlargineWeek 26	1.02	—
Week 104	1.03	—

Secondary/registry result

Change in Fasting VLDL-cholesterol

Time frame:Week 0, week 26, week 104

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL-cholesterol	95% CI
Insulin Degludec/LiraglutideWeek 26	0.85	—
Week 104	0.90	—
Insulin GlargineWeek 26	0.85	—
Week 104	0.88	—

Secondary/registry result

Change in Fasting Triglycerides

Time frame:Week 0, week 26, week 104

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Insulin Degludec/LiraglutideWeek 26	0.84	—
Week 104	0.89	—
Insulin GlargineWeek 26	0.85	—
Week 104	0.89	—

Secondary/registry result

Change in Fasting Free Fatty Acids

Time frame:Week 0, week 26, week 104

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Insulin Degludec/LiraglutideWeek 26	0.68	—
Week 104	0.70	—
Insulin GlargineWeek 26	0.75	—
Week 104	0.78	—

Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 26, week 104

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Insulin Degludec/LiraglutideWeek 26	2.0	—
Week 104	1.7	—
Insulin GlargineWeek 26	-0.4	—
Week 104	-0.5	—

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic)

Time frame:Week 0, week 26, week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Fasting Total Cholesterol

Time frame:Week 0, week 26, week 104

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting LDL-cholesterol

Time frame:Week 0, week 26, week 104

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting HDL-cholesterol

Time frame:Week 0, week 26, week 104

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting VLDL-cholesterol

Time frame:Week 0, week 26, week 104

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Triglycerides

Time frame:Week 0, week 26, week 104

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Fasting Free Fatty Acids

Time frame:Week 0, week 26, week 104

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:Week 0, week 26, week 104

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)

Time frame:Week 0, week 26, week 104

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Insulin Degludec/LiraglutideWeek 26: Physical functioning	1.2	—
Week 104: Physical functioning	0.7	—
Week 26: Role-physical	1.4	—
Week 104: Role-physical	1.4	—
Week 26: Bodily pain	1.5	—
Week 104: Bodily pain	1.6	—
Week 26: General health	2.5	—
Week 104: General health	2.3	—
Week 26: Vitality	1.4	—
Week 104: Vitality	1.5	—
Week 26: Social functioning	1.8	—
Week 104: Social functioning	0.9	—
Week 26: Role-emotional	0.6	—
Week 104: Role-emotional	1.6	—
Week 26: Mental health	1.7	—
Week 104: Mental health	2.5	—
Week 26: PCS	1.6	—
Week 104: PCS	1.0	—
Week 26: MCS	1.3	—
Week 104: MCS	2.0	—
Insulin GlargineWeek 26: Physical functioning	1.1	—
Week 104: Physical functioning	0.6	—
Week 26: Role-physical	0.5	—
Week 104: Role-physical	0.7	—
Week 26: Bodily pain	0.4	—
Week 104: Bodily pain	0.1	—
Week 26: General health	2.1	—
Week 104: General health	2.1	—
Week 26: Vitality	1.4	—
Week 104: Vitality	1.5	—
Week 26: Social functioning	0.9	—
Week 104: Social functioning	1.1	—
Week 26: Role-emotional	0.7	—
Week 104: Role-emotional	1.2	—
Week 26: Mental health	1.3	—
Week 104: Mental health	0.3	—
Week 26: PCS	0.9	—
Week 104: PCS	0.8	—
Week 26: MCS	1.2	—
Week 104: MCS	1.0	—

Secondary/registry result

Change in TRIM-D

Time frame:Week 0, week 26, week 104

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Insulin Degludec/LiraglutideWeek 26	9.6	—
Week 104	11.4	—
Insulin GlargineWeek 26	7.3	—
Week 104	9.5	—

Secondary/protocol endpoint

Time frame:Week 0, week 26, week 104

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in TRIM-D

Time frame:Week 0, week 26, week 104

PGI, change

change from baseline, improvement

Safety / tolerability / PK

44 endpoints

Secondary/registry result

Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	143	—
Insulin Glargine	261	—

Secondary/registry result

Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	319	—
Insulin Glargine	642	—

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	3190	—
Insulin Glargine	3806	—

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	8934	—
Insulin Glargine	10658	—

Secondary/registry result

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	27	—
Insulin Glargine	60	—

Secondary/registry result

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	61	—
Insulin Glargine	164	—

Secondary/registry result

Number of TEAEs During 26 Weeks of Treatment

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Adverse events	95% CI
Insulin Degludec/Liraglutide	718	—
Insulin Glargine	624	—

Secondary/registry result

Number of TEAEs During 104 Weeks of Treatment

Time frame:Week 0 to week 104

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Adverse events	95% CI
Insulin Degludec/Liraglutide	1788	—
Insulin Glargine	1368	—

Secondary/registry result

ECG Evaluation

Time frame:Baseline (within 2 weeks prior to week 0), week 104

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideNormal (Baseline)	335	—
Abnormal NCS (Baseline)	162	—
Abnormal CS (Baseline)	9	—
Normal (week 104)	227	—
Abnormal NCS (week 104)	97	—
Abnormal CS (week 104)	7	—
Insulin GlargineNormal (Baseline)	335	—
Abnormal NCS (Baseline)	165	—
Abnormal CS (Baseline)	4	—
Normal (week 104)	122	—
Abnormal NCS (week 104)	65	—
Abnormal CS (week 104)	2	—

Secondary/registry result

Change in Biochemistry Parameter- Creatinine, Total Bilirubin

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Micromoles per liter (umol/L)	95% CI
Insulin Degludec/LiraglutideWeek 26: creatinine	-0.50	—
Week 104: creatinine	0.75	—
Week 26: total bilirubin	-0.30	—
Week 104: total bilirubin	-0.33	—
Insulin GlargineWeek 26: creatinine	0.25	—
Week 104: creatinine	2.20	—
Week 26: total bilirubin	-0.32	—
Week 104: total bilirubin	-0.59	—

Secondary/registry result

Change in Biochemistry Parameter- Albumin

Time frame:Week 0, week 26, week 104

serum albumin

change from baseline, descriptive

Posted result

Group	Value (mean), Grams per deciliter (g/dL)	95% CI
Insulin Degludec/LiraglutideWeek 26	-0.03	—
Week 104	0.01	—
Insulin GlargineWeek 26	-0.03	—
Week 104	0.03	—

Secondary/registry result

Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Units per liter (U/L)	95% CI
Insulin Degludec/LiraglutideWeek 26: ALP	-4.16	—
Week 104: ALP	-1.35	—
Week 26: ALT	-5.45	—
Week 104: ALT	-5.39	—
Week 26: AST	-1.62	—
Week 104: AST	-1.84	—
Week 26: lipase	9.26	—
Week 104: lipase	5.41	—
Week 26: amylase	9.72	—
Week 104: amylase	7.23	—
Insulin GlargineWeek 26: ALP	-4.33	—
Week 104: ALP	-1.34	—
Week 26: ALT	-3.33	—
Week 104: ALT	-3.45	—
Week 26: AST	-0.39	—
Week 104: AST	-0.67	—
Week 26: lipase	-7.97	—
Week 104: lipase	-13.33	—
Week 26: amylase	2.79	—
Week 104: amylase	-0.13	—

Secondary/registry result

Change in Biochemistry Parameter- Sodium, Potassium and Calcium

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideWeek 26: sodium	0.89	—
Week 104: sodium	1.22	—
Week 26: potassium	-0.05	—
Week 104: potassium	-0.06	—
Week 26: calcium	-0.01	—
Week 104: calcium	-0.07	—
Insulin GlargineWeek 26: sodium	1.03	—
Week 104: sodium	1.47	—
Week 26: potassium	-0.08	—
Week 104: potassium	-0.07	—
Week 26: calcium	-0.00	—
Week 104: calcium	-0.06	—

Secondary/registry result

Change in Haematological Parameter- Haemoglobin

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), g/dL	95% CI
Insulin Degludec/LiraglutideWeek 26	0.08	—
Week 104	-0.00	—
Insulin GlargineWeek 26	0.08	—
Week 104	-0.03	—

Secondary/registry result

Change in Haematological Parameter- Haematocrit

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of red blood cells	95% CI
Insulin Degludec/LiraglutideWeek 26	-0.33	—
Week 104	-0.71	—
Insulin GlargineWeek 26	-0.36	—
Week 104	-0.95	—

Secondary/registry result

Change in Haematological Parameter- Erythrocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), 10^12 cells/L	95% CI
Insulin Degludec/LiraglutideWeek 26	-0.02	—
Week 104	-0.12	—
Insulin GlargineWeek 26	-0.03	—
Week 104	-0.11	—

Secondary/registry result

Change in Haematological Parameter- Thrombocytes and Leukocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), 10^9 cells/L	95% CI
Insulin Degludec/LiraglutideWeek 26: Thrombocytes	8.77	—
Week 104: Thrombocytes	16.87	—
Week 26: Leukocytes	0.49	—
Week 104: Leukocytes	0.07	—
Insulin GlargineWeek 26: Thrombocytes	7.05	—
Week 104: Thrombocytes	18.73	—
Week 26: Leukocytes	0.39	—
Week 104: Leukocytes	0.32	—

Secondary/registry result

Change in Haematological Parameter- Eosinophils

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of eosinophils	95% CI
Insulin Degludec/LiraglutideWeek 26	0.10	—
Week 104	0.32	—
Insulin GlargineWeek 26	0.06	—
Week 104	0.43	—

Secondary/registry result

Change in Haematological Parameter- Neutrophils

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of neutrophils	95% CI
Insulin Degludec/LiraglutideWeek 26	1.86	—
Week 104	1.25	—
Insulin GlargineWeek 26	0.78	—
Week 104	1.21	—

Secondary/registry result

Change in Haematological Parameter- Basophils

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of basophils	95% CI
Insulin Degludec/LiraglutideWeek 26	0.00	—
Week 104	0.20	—
Insulin GlargineWeek 26	-0.00	—
Week 104	0.16	—

Secondary/registry result

Change in Haematological Parameter- Monocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of monocytes	95% CI
Insulin Degludec/LiraglutideWeek 26	-0.10	—
Week 104	0.49	—
Insulin GlargineWeek 26	0.01	—
Week 104	0.59	—

Secondary/registry result

Change in Haematological Parameter- Lymphocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of lymphocytes	95% CI
Insulin Degludec/LiraglutideWeek 26	-1.87	—
Week 104	-2.25	—
Insulin GlargineWeek 26	-0.84	—
Week 104	-2.38	—

Secondary/registry result

Change in Calcitonin

Time frame:Week 0, week 26, week 104

Thyroid event

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek 0: Low	0	—
Week 0: Normal	481	—
Week 0: High	25	—
Week 26: Low	0	—
Week 26: Normal	437	—
Week 26: High	40	—
Week 104: Low	0	—
Week 104: Normal	301	—
Week 104: High	31	—
Insulin GlargineWeek 0: Low	0	—
Week 0: Normal	472	—
Week 0: High	32	—
Week 26: Low	0	—
Week 26: Normal	431	—
Week 26: High	30	—
Week 104: Low	0	—
Week 104: Normal	169	—
Week 104: High	17	—

Secondary/protocol endpoint

Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of TEAEs During 26 Weeks of Treatment

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of TEAEs During 104 Weeks of Treatment

Time frame:Week 0 to week 104

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

ECG Evaluation

Time frame:Baseline (within 2 weeks prior to week 0), week 104

categorical status, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Creatinine, Total Bilirubin

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameter- Sodium, Potassium and Calcium

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Haematocrit

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Erythrocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Thrombocytes and Leukocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Eosinophils

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Neutrophils

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Basophils

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Monocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Lymphocytes

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Calcitonin

Time frame:Week 0, week 26, week 104

Thyroid event

categorical status, event

Other clinical outcomes

2 endpoints

Secondary/registry result

Eye Examination Category

Time frame:Baseline (within 12 weeks prior to week 0), week 104

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideLeft eye: Normal (baseline)	345	—
Left eye: Abnormal NCS (baseline)	151	—
Left eye: Abnormal CS (baseline)	10	—
Left eye: Normal (week 104)	204	—
Left eye: Abnormal NCS (week 104)	97	—
Left eye: Abnormal CS (week 104)	17	—
Right eye: Normal (baseline)	344	—
Right eye: Abnormal NCS (baseline)	151	—
Right eye: Abnormal CS (baseline)	11	—
Right eye: Normal (week 104)	200	—
Right eye: Abnormal NCS (week 104)	99	—
Right eye: Abnormal CS (week 104)	19	—
Insulin GlargineLeft eye: Normal (baseline)	341	—
Left eye: Abnormal NCS (baseline)	155	—
Left eye: Abnormal CS (baseline)	8	—
Left eye: Normal (week 104)	129	—
Left eye: Abnormal NCS (week 104)	50	—
Left eye: Abnormal CS (week 104)	6	—
Right eye: Normal (baseline)	355	—
Right eye: Abnormal NCS (baseline)	143	—
Right eye: Abnormal CS (baseline)	6	—
Right eye: Normal (week 104)	132	—
Right eye: Abnormal NCS (week 104)	48	—
Right eye: Abnormal CS (week 104)	5	—

Secondary/protocol endpoint

Eye Examination Category

Time frame:Baseline (within 12 weeks prior to week 0), week 104

categorical status, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in Biochemistry Parameter- Albumin

Time frame:Week 0, week 26, week 104

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Haematological Parameter- Haemoglobin

Time frame:Week 0, week 26, week 104

change from baseline, descriptive

Publications (3)

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

Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes.
Journal of diabetes science and technology2024 May (month)PMID36710452doi:10.1177/19322968221149041via clinicaltrials gov reference derived + pubmed nct search
A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice.
Diabetes, obesity & metabolism2020 May (month)PMID31903724doi:10.1111/dom.13957via pubmed nct search
Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.
The lancet. Diabetes & endocrinology2019 Aug (month)PMID31189519doi:10.1016/S2213-8587(19)30184-6via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.