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DUAL™ I China

CompletedPhase 3Results posted

A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

36

Recruiting sites

-

Actual enrollment

720

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 IDNCT03172494
Org study IDNN9068-4148
Secondary IDCTR20170004China Drug Trials (China)
Secondary IDU1111-1154-6671World Health Organization (WHO)

Timeline

Milestones

Study start2017-05-26actual
Study first posted2017-06-01actual
Primary completion2019-06-14actual
Study completion2019-07-13actual
Results first posted2020-07-07actual
Last update posted2022-12-14actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 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
•Type 2 diabetes mellitus (clinically diagnosed)
•Male or female, age at least 18 years at the time of signing informed consent
•HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%
•Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:
•Metformin (above or equal to 1500 mg or max tolerated dose) or
•Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or
•Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or
•Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or
•Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)

Exclusion criteria

•Treatment with insulin (except for short-term treatment at the discretion of the investigator)
•Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening
•Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range
•Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin
•Screening calcitonin above or equal to 50 ng/L
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
•Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures
•Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg
•Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment
•History of pancreatitis (acute or chronic)

Endpoints (124)

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
66
Glycemic / diabetes
36
Cardiometabolic biomarkers
16
Weight & body composition
4
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupMean · Kilogram (Kg)95% CI
Insulin Degludec/Liraglutide0.2-
Insulin Degludec1.3-
Liraglutide-2.5-
Secondary/registry result

Change in Waist Circumferance

Time frame:Week 0, week 26

Waist circumference, change

change from baseline, improvement

Posted result

GroupMean · Centimeters (cm)95% CI
Insulin Degludec/Liraglutide-0.3-
Insulin Degludec1.2-
Liraglutide-2.6-
Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumferance

Time frame:Week 0, week 26

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

36 endpoints
Primary/registry result

Change in HbA1c

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMean · Percentage points of HbA1c95% CI
Insulin Degludec/Liraglutide-1.71-
Insulin Degludec-1.20-
Liraglutide-1.16-
Mean treatment difference-0.5995% CI-0.73 - -0.46p<0.0001ANCOVA
Mean treatment difference-0.6395% CI-0.76 - -0.49p<0.0001ANCOVA
Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Insulin Dose

Time frame:Week 26

descriptive

Posted result

GroupMean · Units of insulin (U)95% CI
Insulin Degludec/Liraglutide24.8-
Insulin Degludec30.1-
Secondary/registry result

Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide272-
69-
Insulin Degludec83-
84-
Liraglutide80-
71-
Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide201-
140-
Insulin Degludec48-
119-
Liraglutide41-
110-
Secondary/registry result

Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero

Time frame:Week 26

threshold achievement, improvement

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

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide147-
214-
Insulin Degludec34-
145-
Liraglutide74-
106-
Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero

Time frame:Week 26

threshold achievement, improvement

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

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide111-
250-
Insulin Degludec21-
158-
Liraglutide37-
143-
Secondary/registry result

Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide265-
96-
Insulin Degludec80-
99-
Liraglutide84-
96-
Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide195-
166-
Insulin Degludec46-
133-
Liraglutide43-
137-
Secondary/registry result

Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.

Time frame:Week 26

threshold achievement, improvement

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

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide136-
225-
Insulin Degludec33-
146-
Liraglutide72-
108-
Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.

Time frame:Week 26

threshold achievement, improvement

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

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide103-
258-
Insulin Degludec21-
158-
Liraglutide36-
144-
Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupMean · mmol/L95% CI
Insulin Degludec/Liraglutide-3.64-
Insulin Degludec-3.45-
Liraglutide-1.86-
Secondary/registry result

9-point SMPG Profile

Time frame:Week 26

descriptive, improvement

Posted result

GroupMean · mmol/L95% CI
Insulin Degludec/LiraglutideBefore breakfast5.41-
90 minutes after the start of breakfast8.97-
Before lunch6.31-
90 minutes after the start of the lunch8.87-
Before dinner6.52-
90 minutes after start of the dinner9.33-
At bedtime7.99-
At 4:00 am5.60-
Before breakfast the following day5.35-
Insulin DegludecBefore breakfast5.66-
90 minutes after the start of breakfast9.85-
Before lunch7.10-
90 minutes after the start of the lunch10.18-
Before dinner7.39-
90 minutes after start of the dinner10.27-
At bedtime8.86-
At 4:00 am6.12-
Before breakfast the following day5.47-
LiraglutideBefore breakfast6.89-
90 minutes after the start of breakfast10.04-
Before lunch7.48-
90 minutes after the start of the lunch9.54-
Before dinner7.50-
90 minutes after start of the dinner9.45-
At bedtime8.49-
At 4:00 am6.86-
Before breakfast the following day6.81-
Secondary/registry result

Change in Mean of 9-point SMPG Profile

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

GroupMean · mmol/L95% CI
Insulin Degludec/Liraglutide-3.17-
Insulin Degludec-2.47-
Liraglutide-2.13-
Secondary/registry result

Change in Mean Post-prandial Plasma Glucose (PG) Increments

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

GroupMean · mmol/L95% CI
Insulin Degludec/Liraglutide-0.20-
Insulin Degludec0.09-
Liraglutide-0.54-
Secondary/registry result

Change in Fasting C-peptide - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

GroupGeometric mean · Ratio of fasting C-peptide95% CI
Insulin Degludec/Liraglutide0.54-
Insulin Degludec0.38-
Liraglutide0.98-
Secondary/registry result

Change in Fasting Human Insulin - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

GroupGeometric mean · Ratio of fasting human insulin95% CI
Insulin Degludec/Liraglutide0.53-
Insulin Degludec0.38-
Liraglutide1.04-
Secondary/registry result

Change in Fasting Glucagon - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

GroupGeometric mean · Ratio of fasting glucagon95% CI
Insulin Degludec/Liraglutide0.90-
Insulin Degludec0.95-
Liraglutide0.98-
Secondary/registry result/low confidence

Change in HOMA-B (Beta Cell Function)- Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

GroupGeometric mean · Ratio of HOMA-B (beta cell function)95% CI
Insulin Degludec/Liraglutide1.38-
Insulin Degludec0.94-
Liraglutide1.53-
Secondary/protocol endpoint

Insulin Dose

Time frame:Week 26

descriptive

Secondary/protocol endpoint

Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero

Time frame:Week 26

threshold achievement, improvement

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

Secondary/protocol endpoint

Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

9-point SMPG Profile

Time frame:Week 26

Postprandial glucose

descriptive

Secondary/protocol endpoint

Change in Mean of 9-point SMPG Profile

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Post-prandial Plasma Glucose (PG) Increments

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Fasting C-peptide - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Human Insulin - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint/low confidence

Change in Fasting Glucagon - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint/low confidence

Change in HOMA-B (Beta Cell Function)- Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Cardiometabolic biomarkers

16 endpoints
Secondary/registry result

Change in Fasting Total Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

GroupGeometric mean · Ratio of fasting total cholesterol95% CI
Insulin Degludec/Liraglutide0.94-
Insulin Degludec0.99-
Liraglutide0.97-
Secondary/registry result

Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

Time frame:Week 0, week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

GroupGeometric mean · Ratio of fasting HDL cholesterol95% CI
Insulin Degludec/Liraglutide1.01-
Insulin Degludec1.02-
Liraglutide1.03-
Secondary/registry result

Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

Time frame:Week 0, week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

GroupGeometric mean · Ratio of fasting LDL cholesterol95% CI
Insulin Degludec/Liraglutide0.92-
Insulin Degludec1.01-
Liraglutide0.96-
Secondary/registry result

Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

Time frame:Week 0, week 26

VLDL, change

ratio, improvement

Posted result

GroupGeometric mean · Ratio of fasting VLDL cholesterol95% CI
Insulin Degludec/Liraglutide0.90-
Insulin Degludec0.84-
Liraglutide0.92-
Secondary/registry result

Change in Fasting Triglycerides - Ratio to Baseline.

Time frame:Week 0, week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupGeometric mean · Ratio of fasting triglycerides95% CI
Insulin Degludec/Liraglutide0.88-
Insulin Degludec0.82-
Liraglutide0.90-
Secondary/registry result

Change in Fasting Free Fatty Acid - Ratio to Baseline

Time frame:Week 0, week 26

Free fatty acids, change

ratio, improvement

Posted result

GroupGeometric mean · Ratio of fasting free fatty acid95% CI
Insulin Degludec/Liraglutide0.55-
Insulin Degludec0.48-
Liraglutide0.80-
Secondary/registry result

Change in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Posted result

GroupMean · Beats per minuts (beats/min)95% CI
Insulin Degludec/Liraglutide4.6-
Insulin Degludec-0.1-
Liraglutide4.9-
Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 26

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Posted result

GroupMean · Millimeters of mercury (mmHg)95% CI
Insulin Degludec/LiraglutideSystolic blood pressure-3.5-
Distolic blood pressure-0.4-
Insulin DegludecSystolic blood pressure-1.2-
Distolic blood pressure-0.7-
LiraglutideSystolic blood pressure-3.3-
Distolic blood pressure0.0-
Secondary/protocol endpoint

Change in Fasting Total Cholesterol - Ratio to Baseline

Time frame:Week 0, week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

Time frame:Week 0, week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

Time frame:Week 0, week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

Time frame:Week 0, week 26

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Triglycerides - Ratio to Baseline.

Time frame:Week 0, week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Fasting Free Fatty Acid - Ratio to Baseline

Time frame:Week 0, week 26

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 26

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Safety / tolerability / PK

66 endpoints
Secondary/registry result

Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Weeks 0-26

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

GroupNumber · (Number of episodes/PYE)*10095% CI
Insulin Degludec/Liraglutide23.94-
Insulin Degludec17.01-
Liraglutide3.60-
Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAE)

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Posted result

GroupNumber · (Number of AEs/PYE)*10095% CI
Insulin Degludec/Liraglutide410.82-
Insulin Degludec306.19-
Liraglutide541.00-
Secondary/registry result

Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

GroupNumber · (Number of episodes/PYE)*10095% CI
Insulin Degludec/Liraglutide4.45-
Insulin Degludec4.54-
Secondary/registry result

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

GroupNumber · (Number of episodes/PYE)*10095% CI
Insulin Degludec/Liraglutide15.03-
Insulin Degludec9.07-
Liraglutide1.20-
Secondary/registry result

Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

GroupNumber · (Number of episodes/PYE)*10095% CI
Insulin Degludec/Liraglutide2.78-
Insulin Degludec3.40-
Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

GroupNumber · (Number of episodes/PYE)*10095% CI
Insulin Degludec/Liraglutide668.55-
Insulin Degludec746.20-
Liraglutide37.19-
Secondary/registry result

Change in Physical Examination

Time frame:Week -2, week 26

descriptive

Posted result

GroupParticipants95% CI
Insulin Degludec/LiraglutideWeek -2: Cardiovascular system353-
Week -2: Cardiovascular system2-
Week -2: Cardiovascular system3-
Week 26: Cardiovascular system336-
Week 26: Cardiovascular system3-
Week 26: Cardiovascular system2-
Week -2: Central and peripheral nervous system355-
Week -2: Central and peripheral nervous system1-
Week -2: Central and peripheral nervous system2-
Week 26: Central and peripheral nervous system338-
Week 26: Central and peripheral nervous system1-
Week 26: Central and peripheral nervous system2-
Week -2: Gastrointestinal system including mouth355-
Week -2: Gastrointestinal system including mouth3-
Week -2: Gastrointestinal system including mouth0-
Week 26: Gastrointestinal system including mouth339-
Week 26: Gastrointestinal system including mouth2-
Week 26: Gastrointestinal system including mouth0-
Week -2: General appearance351-
Week -2: General appearance3-
Week -2: General appearance4-
Week 26: General appearance336-
Week 26: General appearance2-
Week 26: General appearance3-
Week -2: Head, ears, eyes, nose, throat, neck348-
Week -2: Head, ears, eyes, nose, throat, neck6-
Week -2: Head, ears, eyes, nose, throat, neck4-
Week 26: Head, ears, eyes, nose, throat, neck332-
Week 26: Head, ears, eyes, nose, throat, neck6-
Week 26: Head, ears, eyes, nose, throat, neck3-
Week -2: Lymph node palpation357-
Week -2: Lymph node palpation0-
Week -2: Lymph node palpation1-
Week 26: Lymph node palpation340-
Week 26: Lymph node palpation0-
Week 26: Lymph node palpation1-
Week -2: Musculoskeletal system353-
Week -2: Musculoskeletal system2-
Week -2: Musculoskeletal system3-
Week 26: Musculoskeletal system332-
Week 26: Musculoskeletal system2-
Week 26: Musculoskeletal system7-
Week-2: Respiratory system358-
Week-2: Respiratory system0-
Week-2: Respiratory system0-
Week 26: Respiratory system341-
Week 26: Respiratory system0-
Week 26: Respiratory system0-
week -2: Skin312-
week -2: Skin37-
week -2: Skin9-
Week 26: Skin297-
Week 26: Skin36-
Week 26: Skin8-
Week -2: Thyroid gland348-
Week -2: Thyroid gland5-
Week -2: Thyroid gland5-
Week 26: Thyroid gland334-
Week 26: Thyroid gland3-
Week 26: Thyroid gland4-
Insulin DegludecWeek -2: Cardiovascular system173-
Week -2: Cardiovascular system2-
Week -2: Cardiovascular system0-
Week 26: Cardiovascular system166-
Week 26: Cardiovascular system1-
Week 26: Cardiovascular system0-
Week -2: Central and peripheral nervous system172-
Week -2: Central and peripheral nervous system0-
Week -2: Central and peripheral nervous system3-
Week 26: Central and peripheral nervous system164-
Week 26: Central and peripheral nervous system0-
Week 26: Central and peripheral nervous system3-
Week -2: Gastrointestinal system including mouth174-
Week -2: Gastrointestinal system including mouth1-
Week -2: Gastrointestinal system including mouth0-
Week 26: Gastrointestinal system including mouth166-
Week 26: Gastrointestinal system including mouth1-
Week 26: Gastrointestinal system including mouth0-
Week -2: General appearance169-
Week -2: General appearance2-
Week -2: General appearance4-
Week 26: General appearance161-
Week 26: General appearance2-
Week 26: General appearance4-
Week -2: Head, ears, eyes, nose, throat, neck170-
Week -2: Head, ears, eyes, nose, throat, neck4-
Week -2: Head, ears, eyes, nose, throat, neck1-
Week 26: Head, ears, eyes, nose, throat, neck164-
Week 26: Head, ears, eyes, nose, throat, neck3-
Week 26: Head, ears, eyes, nose, throat, neck0-
Week -2: Lymph node palpation174-
Week -2: Lymph node palpation0-
Week -2: Lymph node palpation1-
Week 26: Lymph node palpation166-
Week 26: Lymph node palpation0-
Week 26: Lymph node palpation1-
Week -2: Musculoskeletal system172-
Week -2: Musculoskeletal system2-
Week -2: Musculoskeletal system1-
Week 26: Musculoskeletal system165-
Week 26: Musculoskeletal system1-
Week 26: Musculoskeletal system1-
Week-2: Respiratory system175-
Week-2: Respiratory system0-
Week-2: Respiratory system0-
Week 26: Respiratory system167-
Week 26: Respiratory system0-
Week 26: Respiratory system0-
week -2: Skin152-
week -2: Skin20-
week -2: Skin3-
Week 26: Skin146-
Week 26: Skin19-
Week 26: Skin2-
Week -2: Thyroid gland171-
Week -2: Thyroid gland1-
Week -2: Thyroid gland3-
Week 26: Thyroid gland163-
Week 26: Thyroid gland2-
Week 26: Thyroid gland2-
LiraglutideWeek -2: Cardiovascular system180-
Week -2: Cardiovascular system0-
Week -2: Cardiovascular system0-
Week 26: Cardiovascular system151-
Week 26: Cardiovascular system0-
Week 26: Cardiovascular system0-
Week -2: Central and peripheral nervous system179-
Week -2: Central and peripheral nervous system0-
Week -2: Central and peripheral nervous system1-
Week 26: Central and peripheral nervous system150-
Week 26: Central and peripheral nervous system0-
Week 26: Central and peripheral nervous system1-
Week -2: Gastrointestinal system including mouth179-
Week -2: Gastrointestinal system including mouth1-
Week -2: Gastrointestinal system including mouth0-
Week 26: Gastrointestinal system including mouth150-
Week 26: Gastrointestinal system including mouth1-
Week 26: Gastrointestinal system including mouth0-
Week -2: General appearance177-
Week -2: General appearance1-
Week -2: General appearance2-
Week 26: General appearance150-
Week 26: General appearance0-
Week 26: General appearance1-
Week -2: Head, ears, eyes, nose, throat, neck175-
Week -2: Head, ears, eyes, nose, throat, neck3-
Week -2: Head, ears, eyes, nose, throat, neck2-
Week 26: Head, ears, eyes, nose, throat, neck150-
Week 26: Head, ears, eyes, nose, throat, neck1-
Week 26: Head, ears, eyes, nose, throat, neck0-
Week -2: Lymph node palpation180-
Week -2: Lymph node palpation0-
Week -2: Lymph node palpation0-
Week 26: Lymph node palpation151-
Week 26: Lymph node palpation0-
Week 26: Lymph node palpation0-
Week -2: Musculoskeletal system177-
Week -2: Musculoskeletal system0-
Week -2: Musculoskeletal system3-
Week 26: Musculoskeletal system149-
Week 26: Musculoskeletal system0-
Week 26: Musculoskeletal system2-
Week-2: Respiratory system180-
Week-2: Respiratory system0-
Week-2: Respiratory system0-
Week 26: Respiratory system151-
Week 26: Respiratory system0-
Week 26: Respiratory system0-
week -2: Skin156-
week -2: Skin20-
week -2: Skin4-
Week 26: Skin134-
Week 26: Skin15-
Week 26: Skin2-
Week -2: Thyroid gland179-
Week -2: Thyroid gland1-
Week -2: Thyroid gland0-
Week 26: Thyroid gland151-
Week 26: Thyroid gland0-
Week 26: Thyroid gland0-
Secondary/registry result

Eye Examination

Time frame:Week -2, Week 26

categorical status, descriptive

Posted result

GroupParticipants95% CI
Insulin Degludec/LiraglutideWeek -2: Left eye222-
Week -2: Left eye45-
Week -2: Left eye91-
Week 26: Left eye217-
Week 26: Left eye39-
Week 26: Left eye85-
Week -2: Right eye230-
Week -2: Right eye42-
Week -2: Right eye86-
Week 26: Right eye217-
Week 26: Right eye40-
Week 26: Right eye84-
Insulin DegludecWeek -2: Left eye109-
Week -2: Left eye14-
Week -2: Left eye52-
Week 26: Left eye99-
Week 26: Left eye20-
Week 26: Left eye48-
Week -2: Right eye112-
Week -2: Right eye16-
Week -2: Right eye47-
Week 26: Right eye103-
Week 26: Right eye23-
Week 26: Right eye41-
LiraglutideWeek -2: Left eye110-
Week -2: Left eye20-
Week -2: Left eye50-
Week 26: Left eye100-
Week 26: Left eye13-
Week 26: Left eye38-
Week -2: Right eye111-
Week -2: Right eye22-
Week -2: Right eye47-
Week 26: Right eye96-
Week 26: Right eye15-
Week 26: Right eye40-
Secondary/registry result

Change in Electrocardiogram (ECG)

Time frame:Week -2, week 26

categorical status, descriptive

Posted result

GroupParticipants95% CI
Insulin Degludec/LiraglutideWeek -2223-
Week -294-
Week -241-
Week 26227-
Week 2676-
Week 2638-
Insulin DegludecWeek -2109-
Week -246-
Week -220-
Week 26108-
Week 2647-
Week 2612-
LiraglutideWeek -2108-
Week -252-
Week -220-
Week 2687-
Week 2640-
Week 2624-
Secondary/registry result

Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · Units per liter (U/L)95% CI
Insulin Degludec/LiraglutideAlkaline phosphatase-2.0-
ALT-4.63-
AST-1.31-
Creatine kinase10.67-
Amylase9.84-
Lipase16.13-
Insulin DegludecAlkaline phosphatase-2.29-
ALT-6.17-
AST-2.65-
Creatine kinase15.37-
Amylase5.09-
Lipase-1.87-
LiraglutideAlkaline phosphatase-0.48-
ALT-2.81-
AST-0.99-
Creatine kinase0.52-
Amylase5.68-
Lipase14.11-
Secondary/registry result

Change in Biochemistry Parameters (Albumin Serum, Total Protein)

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · grams per decileter (g/dL)95% CI
Insulin Degludec/LiraglutideAlbumin serum-0.05-
Total protein-0.08-
Insulin DegludecAlbumin serum-0.09-
Total protein-0.08-
LiraglutideAlbumin serum0.04-
Total protein-0.01-
Secondary/registry result

Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · mmol/L95% CI
Insulin Degludec/LiraglutideCalcium serum (total)-0.01-
Calcium corrected serum-0.00-
Sodium serum1.21-
Urea serum0.05-
Potassium serum-0.04-
Insulin DegludecCalcium serum (total)-0.02-
Calcium corrected serum-0.00-
Sodium serum0.98-
Urea serum0.03-
Potassium serum-0.09-
LiraglutideCalcium serum (total)-0.00-
Calcium corrected serum-0.01-
Sodium serum0.32-
Urea serum0.16-
Potassium serum-0.04-
Secondary/registry result

Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum

Time frame:Week 0, week 26

change from baseline, descriptive

componentstotal bilirubin change, serum creatinine change

Posted result

GroupMean · micromoles per liter (umol/L)95% CI
Insulin Degludec/LiraglutideTotal bilirubin-0.78-
creatinine serum1.02-
Insulin DegludecTotal bilirubin-0.55-
creatinine serum1.36-
LiraglutideTotal bilirubin-1.16-
creatinine serum-0.60-
Secondary/registry result

Change in Haematological Parameter: Erythrocytes Blood

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · 10^12 cells per liter (10^12/L)95% CI
Insulin Degludec/Liraglutide-0.05-
Insulin Degludec-0.00-
Liraglutide-0.05-
Secondary/registry result

Change in Haematological Parameter: Haematocrits

Time frame:Week 0, week 26

hematocrit

change from baseline, descriptive

LOINC 4545-0

Posted result

GroupMean · Percentage points (%) of red blood cells95% CI
Insulin Degludec/Liraglutide-0.56-
Insulin Degludec-0.49-
Liraglutide-0.42-
Secondary/registry result

Change in Haemotological Parameter- Eosinophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · % of eosinophils95% CI
Insulin Degludec/Liraglutide-0.06-
Insulin Degludec0.19-
Liraglutide0.11-
Secondary/registry result

Change in Haematological Parameter - Neutrophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · % of neutrophils95% CI
Insulin Degludec/Liraglutide0.57-
Insulin Degludec0.18-
Liraglutide-0.53-
Secondary/registry result

Change in Haematological Parameter: Basophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · % of basophils95% CI
Insulin Degludec/Liraglutide-0.02-
Insulin Degludec-0.01-
Liraglutide-0.03-
Secondary/registry result

Change in Haemotological Parameter- Monocytes

Time frame:Week 0, week 26

monocytes change baseline

change from baseline, descriptive

LOINC 742-7

Posted result

GroupMean · % of monocytes95% CI
Insulin Degludec/Liraglutide-0.03-
Insulin Degludec0.01-
Liraglutide0.05-
Secondary/registry result

Change in Haematological Parameter - Lymphocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · % of lymphocytes95% CI
Insulin Degludec/Liraglutide-0.46-
Insulin Degludec-0.38-
Liraglutide0.40-
Secondary/registry result

Change in Haematology: Haemoglobin Blood

Time frame:Week 0, week 26

change from baseline, descriptive

LOINC 718-7

Posted result

GroupMean · mmol/L95% CI
Insulin Degludec/Liraglutide-0.10-
Insulin Degludec-0.06-
Liraglutide-0.05-
Secondary/registry result

Change in Haematologcal Parameter: Leukocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · 10^9 cells per liter (10^9/L)95% CI
Insulin Degludec/Liraglutide0.25-
Insulin Degludec0.23-
Liraglutide-0.01-
Secondary/registry result

Change in Haematological Parameter: Thrombocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

GroupMean · 10^9 cells per liter (10^9/L)95% CI
Insulin Degludec/Liraglutide8.19-
Insulin Degludec8.32-
Liraglutide4.32-
Secondary/registry result

Change in Calcitonin

Time frame:Week 0, week 26

Thyroid event

categorical status, event

Posted result

GroupParticipants95% CI
Insulin Degludec/LiraglutideWeek 00-
Week 0351-
Week 07-
Week 260-
Week 26334-
Week 266-
Insulin DegludecWeek 00-
Week 0172-
Week 03-
Week 260-
Week 26165-
Week 262-
LiraglutideWeek 00-
Week 0178-
Week 02-
Week 260-
Week 26147-
Week 263-
Secondary/registry result

Urinalysis (Protein, Glucose, Erythrocytes and Ketones)

Time frame:Week 0, week 26

categorical status, descriptive

Posted result

GroupParticipants95% CI
Insulin Degludec/LiraglutideWeek 0: Erythrocytes299-
Week 0: Erythrocytes36-
Week 0: Erythrocytes22-
Week 26: Erythrocytes297-
Week 26: Erythrocytes28-
Week 26: Erythrocytes14-
Week 0: Glucose253-
Week 0: Glucose35-
Week 0: Glucose69-
Week 26: Glucose322-
Week 26: Glucose11-
Week 26: Glucose6-
Week 0: Ketones325-
Week 0: Ketones25-
Week 0: Ketones7-
Week 26: Ketones334-
Week 26: Ketones4-
Week 26: Ketones1-
Week 0: Protein216-
Week 0: Protein86-
Week 0: Protein55-
Week 26: Protein254-
Week 26: Protein58-
Week 26: Protein27-
Insulin DegludecWeek 0: Erythrocytes153-
Week 0: Erythrocytes16-
Week 0: Erythrocytes6-
Week 26: Erythrocytes146-
Week 26: Erythrocytes16-
Week 26: Erythrocytes5-
Week 0: Glucose119-
Week 0: Glucose19-
Week 0: Glucose37-
Week 26: Glucose157-
Week 26: Glucose3-
Week 26: Glucose7-
Week 0: Ketones152-
Week 0: Ketones20-
Week 0: Ketones3-
Week 26: Ketones163-
Week 26: Ketones3-
Week 26: Ketones1-
Week 0: Protein104-
Week 0: Protein40-
Week 0: Protein31-
Week 26: Protein120-
Week 26: Protein26-
Week 26: Protein21-
LiraglutideWeek 0: Erythrocytes156-
Week 0: Erythrocytes16-
Week 0: Erythrocytes8-
Week 26: Erythrocytes136-
Week 26: Erythrocytes11-
Week 26: Erythrocytes4-
Week 0: Glucose123-
Week 0: Glucose18-
Week 0: Glucose39-
Week 26: Glucose131-
Week 26: Glucose5-
Week 26: Glucose15-
Week 0: Ketones167-
Week 0: Ketones11-
Week 0: Ketones2-
Week 26: Ketones141-
Week 26: Ketones10-
Week 26: Ketones0-
Week 0: Protein116-
Week 0: Protein37-
Week 0: Protein27-
Week 26: Protein105-
Week 26: Protein28-
Week 26: Protein18-
Secondary/registry result

Occurence of Anti-insulin Degludec Specific Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

GroupMean · %B/T95% CI
Insulin Degludec/Liraglutide0.22-
Insulin Degludec0.12-
Secondary/registry result

Occurence of Antibodies Cross-reacting to Human Insulin

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

GroupMean · %B/T95% CI
Insulin Degludec/Liraglutide6.61-
Insulin Degludec2.99-
Secondary/registry result

Occurence of Total Insulin Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

GroupMean · %B/T95% CI
Insulin Degludec/Liraglutide6.83-
Insulin Degludec3.11-
Secondary/registry result

Occurence of Anti-liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide45-
287-
Liraglutide40-
120-
Secondary/registry result

Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide6-
Liraglutide3-
Secondary/registry result

Occurence of Neutralising Liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide9-
Liraglutide8-
Secondary/registry result

Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupParticipants95% CI
Insulin Degludec/Liraglutide0-
Liraglutide0-
Secondary/registry result

Serum Concentrations of Insulin Degludec

Time frame:Week 0, week 26

Cmax

concentration, descriptive

Posted result

GroupGeometric mean · pmol/L95% CI
Insulin Degludec/Liraglutide3583-
Insulin Degludec4133-
Secondary/registry result

Plasma Concentration of Liraglutide

Time frame:Week 0, week 26

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupGeometric mean · pmol/L95% CI
Insulin Degludec/Liraglutide9963-
Liraglutide21602-
Secondary/protocol endpoint

Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAE)

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.

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

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week -2, week 26

categorical status, descriptive

Secondary/protocol endpoint

Change in Electrocardiogram (ECG)

Time frame:Week -2, week 26

categorical status, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameters (Albumin Serum, Total Protein)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum

Time frame:Week 0, week 26

change from baseline, descriptive

componentscalcium serum total change, calcium corrected serum change, potassium serum change, sodium serum change, urea serum change

Secondary/protocol endpoint

Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum

Time frame:Week 0, week 26

change from baseline, descriptive

componentstotal bilirubin serum change, creatinine serum change

Secondary/protocol endpoint

Change in Haematological Parameter: Erythrocytes Blood

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter: Haematocrits

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haemotological Parameter- Eosinophils

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter - Neutrophils

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter: Basophils

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter - Lymphocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematology: Haemoglobin Blood

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematologcal Parameter: Leukocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter: Thrombocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Calcitonin

Time frame:Week 0, week 26

Thyroid event

categorical status, event

Secondary/protocol endpoint

Urinalysis (Protein, Glucose, Erythrocytes and Ketones)

Time frame:Week 0, week 26

categorical status, descriptive

Secondary/protocol endpoint

Occurence of Anti-insulin Degludec Specific Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Occurence of Antibodies Cross-reacting to Human Insulin

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Occurence of Total Insulin Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Occurence of Anti-liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Occurence of Neutralising Liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Serum Concentrations of Insulin Degludec

Time frame:Week 0, week 26

Cmax

concentration, descriptive

Secondary/protocol endpoint

Plasma Concentration of Liraglutide

Time frame:Week 0, week 26

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Eye Examination

Time frame:Week -2, Week 26

categorical status, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in Haemotological Parameter- Monocytes

Time frame:Week 0, week 26

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

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.