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

Recruiting sites

—

Enrollment

720

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 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

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

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

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Other clinical outcomes

Other (unclassified)

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

Group	Value (mean), Kilogram (Kg)	95% CI
Insulin Degludec/Liraglutide	0.2	—
Insulin Degludec	1.3	—
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

Group	Value (mean), Centimeters (cm)	95% CI
Insulin Degludec/Liraglutide	-0.3	—
Insulin Degludec	1.2	—
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

Group	Value (mean), Percentage points of HbA1c	95% 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

Group	Value (mean), Units of insulin (U)	95% CI
Insulin Degludec/Liraglutide	24.8	—
Insulin Degludec	30.1	—

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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	272	—
	69	—
Insulin Degludec	83	—
	84	—
Liraglutide	80	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	201	—
	140	—
Insulin Degludec	48	—
	119	—
Liraglutide	41	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	147	—
	214	—
Insulin Degludec	34	—
	145	—
Liraglutide	74	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	111	—
	250	—
Insulin Degludec	21	—
	158	—
Liraglutide	37	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	265	—
	96	—
Insulin Degludec	80	—
	99	—
Liraglutide	84	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	195	—
	166	—
Insulin Degludec	46	—
	133	—
Liraglutide	43	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	136	—
	225	—
Insulin Degludec	33	—
	146	—
Liraglutide	72	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	103	—
	258	—
Insulin Degludec	21	—
	158	—
Liraglutide	36	—
	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

Group	Value (mean), mmol/L	95% 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

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideBefore breakfast	5.41	—
90 minutes after the start of breakfast	8.97	—
Before lunch	6.31	—
90 minutes after the start of the lunch	8.87	—
Before dinner	6.52	—
90 minutes after start of the dinner	9.33	—
At bedtime	7.99	—
At 4:00 am	5.60	—
Before breakfast the following day	5.35	—
Insulin DegludecBefore breakfast	5.66	—
90 minutes after the start of breakfast	9.85	—
Before lunch	7.10	—
90 minutes after the start of the lunch	10.18	—
Before dinner	7.39	—
90 minutes after start of the dinner	10.27	—
At bedtime	8.86	—
At 4:00 am	6.12	—
Before breakfast the following day	5.47	—
LiraglutideBefore breakfast	6.89	—
90 minutes after the start of breakfast	10.04	—
Before lunch	7.48	—
90 minutes after the start of the lunch	9.54	—
Before dinner	7.50	—
90 minutes after start of the dinner	9.45	—
At bedtime	8.49	—
At 4:00 am	6.86	—
Before breakfast the following day	6.81	—

Secondary/registry result

Change in Mean of 9-point SMPG Profile

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% 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

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-0.20	—
Insulin Degludec	0.09	—
Liraglutide	-0.54	—

Secondary/registry result

Change in Fasting C-peptide - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting C-peptide	95% CI
Insulin Degludec/Liraglutide	0.54	—
Insulin Degludec	0.38	—
Liraglutide	0.98	—

Secondary/registry result

Change in Fasting Human Insulin - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting human insulin	95% CI
Insulin Degludec/Liraglutide	0.53	—
Insulin Degludec	0.38	—
Liraglutide	1.04	—

Secondary/registry result

Change in Fasting Glucagon - Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting glucagon	95% CI
Insulin Degludec/Liraglutide	0.90	—
Insulin Degludec	0.95	—
Liraglutide	0.98	—

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

Group	Value (geometric_mean), Ratio of HOMA-B (beta cell function)	95% CI
Insulin Degludec/Liraglutide	1.38	—
Insulin Degludec	0.94	—
Liraglutide	1.53	—

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

Group	Value (geometric_mean), Ratio of fasting total cholesterol	95% CI
Insulin Degludec/Liraglutide	0.94	—
Insulin Degludec	0.99	—
Liraglutide	0.97	—

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

Group	Value (geometric_mean), Ratio of fasting HDL cholesterol	95% CI
Insulin Degludec/Liraglutide	1.01	—
Insulin Degludec	1.02	—
Liraglutide	1.03	—

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

Group	Value (geometric_mean), Ratio of fasting LDL cholesterol	95% CI
Insulin Degludec/Liraglutide	0.92	—
Insulin Degludec	1.01	—
Liraglutide	0.96	—

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

Group	Value (geometric_mean), Ratio of fasting VLDL cholesterol	95% CI
Insulin Degludec/Liraglutide	0.90	—
Insulin Degludec	0.84	—
Liraglutide	0.92	—

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

Group	Value (geometric_mean), Ratio of fasting triglycerides	95% CI
Insulin Degludec/Liraglutide	0.88	—
Insulin Degludec	0.82	—
Liraglutide	0.90	—

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

Group	Value (geometric_mean), Ratio of fasting free fatty acid	95% CI
Insulin Degludec/Liraglutide	0.55	—
Insulin Degludec	0.48	—
Liraglutide	0.80	—

Secondary/registry result

Change in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minuts (beats/min)	95% CI
Insulin Degludec/Liraglutide	4.6	—
Insulin Degludec	-0.1	—
Liraglutide	4.9	—

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

Group	Value (mean), 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 pressure	0.0	—

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

Group	Value (number), (Number of episodes/PYE)*100	95% CI
Insulin Degludec/Liraglutide	23.94	—
Insulin Degludec	17.01	—
Liraglutide	3.60	—

Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAE)

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), (Number of AEs/PYE)*100	95% CI
Insulin Degludec/Liraglutide	410.82	—
Insulin Degludec	306.19	—
Liraglutide	541.00	—

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

Group	Value (number), (Number of episodes/PYE)*100	95% CI
Insulin Degludec/Liraglutide	4.45	—
Insulin Degludec	4.54	—

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

Group	Value (number), (Number of episodes/PYE)*100	95% CI
Insulin Degludec/Liraglutide	15.03	—
Insulin Degludec	9.07	—
Liraglutide	1.20	—

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

Group	Value (number), (Number of episodes/PYE)*100	95% CI
Insulin Degludec/Liraglutide	2.78	—
Insulin Degludec	3.40	—

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

Group	Value (number), (Number of episodes/PYE)*100	95% CI
Insulin Degludec/Liraglutide	668.55	—
Insulin Degludec	746.20	—
Liraglutide	37.19	—

Secondary/registry result

Change in Physical Examination

Time frame:Week -2, week 26

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek -2: Cardiovascular system	353	—
Week -2: Cardiovascular system	2	—
Week -2: Cardiovascular system	3	—
Week 26: Cardiovascular system	336	—
Week 26: Cardiovascular system	3	—
Week 26: Cardiovascular system	2	—
Week -2: Central and peripheral nervous system	355	—
Week -2: Central and peripheral nervous system	1	—
Week -2: Central and peripheral nervous system	2	—
Week 26: Central and peripheral nervous system	338	—
Week 26: Central and peripheral nervous system	1	—
Week 26: Central and peripheral nervous system	2	—
Week -2: Gastrointestinal system including mouth	355	—
Week -2: Gastrointestinal system including mouth	3	—
Week -2: Gastrointestinal system including mouth	0	—
Week 26: Gastrointestinal system including mouth	339	—
Week 26: Gastrointestinal system including mouth	2	—
Week 26: Gastrointestinal system including mouth	0	—
Week -2: General appearance	351	—
Week -2: General appearance	3	—
Week -2: General appearance	4	—
Week 26: General appearance	336	—
Week 26: General appearance	2	—
Week 26: General appearance	3	—
Week -2: Head, ears, eyes, nose, throat, neck	348	—
Week -2: Head, ears, eyes, nose, throat, neck	6	—
Week -2: Head, ears, eyes, nose, throat, neck	4	—
Week 26: Head, ears, eyes, nose, throat, neck	332	—
Week 26: Head, ears, eyes, nose, throat, neck	6	—
Week 26: Head, ears, eyes, nose, throat, neck	3	—
Week -2: Lymph node palpation	357	—
Week -2: Lymph node palpation	0	—
Week -2: Lymph node palpation	1	—
Week 26: Lymph node palpation	340	—
Week 26: Lymph node palpation	0	—
Week 26: Lymph node palpation	1	—
Week -2: Musculoskeletal system	353	—
Week -2: Musculoskeletal system	2	—
Week -2: Musculoskeletal system	3	—
Week 26: Musculoskeletal system	332	—
Week 26: Musculoskeletal system	2	—
Week 26: Musculoskeletal system	7	—
Week-2: Respiratory system	358	—
Week-2: Respiratory system	0	—
Week-2: Respiratory system	0	—
Week 26: Respiratory system	341	—
Week 26: Respiratory system	0	—
Week 26: Respiratory system	0	—
week -2: Skin	312	—
week -2: Skin	37	—
week -2: Skin	9	—
Week 26: Skin	297	—
Week 26: Skin	36	—
Week 26: Skin	8	—
Week -2: Thyroid gland	348	—
Week -2: Thyroid gland	5	—
Week -2: Thyroid gland	5	—
Week 26: Thyroid gland	334	—
Week 26: Thyroid gland	3	—
Week 26: Thyroid gland	4	—
Insulin DegludecWeek -2: Cardiovascular system	173	—
Week -2: Cardiovascular system	2	—
Week -2: Cardiovascular system	0	—
Week 26: Cardiovascular system	166	—
Week 26: Cardiovascular system	1	—
Week 26: Cardiovascular system	0	—
Week -2: Central and peripheral nervous system	172	—
Week -2: Central and peripheral nervous system	0	—
Week -2: Central and peripheral nervous system	3	—
Week 26: Central and peripheral nervous system	164	—
Week 26: Central and peripheral nervous system	0	—
Week 26: Central and peripheral nervous system	3	—
Week -2: Gastrointestinal system including mouth	174	—
Week -2: Gastrointestinal system including mouth	1	—
Week -2: Gastrointestinal system including mouth	0	—
Week 26: Gastrointestinal system including mouth	166	—
Week 26: Gastrointestinal system including mouth	1	—
Week 26: Gastrointestinal system including mouth	0	—
Week -2: General appearance	169	—
Week -2: General appearance	2	—
Week -2: General appearance	4	—
Week 26: General appearance	161	—
Week 26: General appearance	2	—
Week 26: General appearance	4	—
Week -2: Head, ears, eyes, nose, throat, neck	170	—
Week -2: Head, ears, eyes, nose, throat, neck	4	—
Week -2: Head, ears, eyes, nose, throat, neck	1	—
Week 26: Head, ears, eyes, nose, throat, neck	164	—
Week 26: Head, ears, eyes, nose, throat, neck	3	—
Week 26: Head, ears, eyes, nose, throat, neck	0	—
Week -2: Lymph node palpation	174	—
Week -2: Lymph node palpation	0	—
Week -2: Lymph node palpation	1	—
Week 26: Lymph node palpation	166	—
Week 26: Lymph node palpation	0	—
Week 26: Lymph node palpation	1	—
Week -2: Musculoskeletal system	172	—
Week -2: Musculoskeletal system	2	—
Week -2: Musculoskeletal system	1	—
Week 26: Musculoskeletal system	165	—
Week 26: Musculoskeletal system	1	—
Week 26: Musculoskeletal system	1	—
Week-2: Respiratory system	175	—
Week-2: Respiratory system	0	—
Week-2: Respiratory system	0	—
Week 26: Respiratory system	167	—
Week 26: Respiratory system	0	—
Week 26: Respiratory system	0	—
week -2: Skin	152	—
week -2: Skin	20	—
week -2: Skin	3	—
Week 26: Skin	146	—
Week 26: Skin	19	—
Week 26: Skin	2	—
Week -2: Thyroid gland	171	—
Week -2: Thyroid gland	1	—
Week -2: Thyroid gland	3	—
Week 26: Thyroid gland	163	—
Week 26: Thyroid gland	2	—
Week 26: Thyroid gland	2	—
LiraglutideWeek -2: Cardiovascular system	180	—
Week -2: Cardiovascular system	0	—
Week -2: Cardiovascular system	0	—
Week 26: Cardiovascular system	151	—
Week 26: Cardiovascular system	0	—
Week 26: Cardiovascular system	0	—
Week -2: Central and peripheral nervous system	179	—
Week -2: Central and peripheral nervous system	0	—
Week -2: Central and peripheral nervous system	1	—
Week 26: Central and peripheral nervous system	150	—
Week 26: Central and peripheral nervous system	0	—
Week 26: Central and peripheral nervous system	1	—
Week -2: Gastrointestinal system including mouth	179	—
Week -2: Gastrointestinal system including mouth	1	—
Week -2: Gastrointestinal system including mouth	0	—
Week 26: Gastrointestinal system including mouth	150	—
Week 26: Gastrointestinal system including mouth	1	—
Week 26: Gastrointestinal system including mouth	0	—
Week -2: General appearance	177	—
Week -2: General appearance	1	—
Week -2: General appearance	2	—
Week 26: General appearance	150	—
Week 26: General appearance	0	—
Week 26: General appearance	1	—
Week -2: Head, ears, eyes, nose, throat, neck	175	—
Week -2: Head, ears, eyes, nose, throat, neck	3	—
Week -2: Head, ears, eyes, nose, throat, neck	2	—
Week 26: Head, ears, eyes, nose, throat, neck	150	—
Week 26: Head, ears, eyes, nose, throat, neck	1	—
Week 26: Head, ears, eyes, nose, throat, neck	0	—
Week -2: Lymph node palpation	180	—
Week -2: Lymph node palpation	0	—
Week -2: Lymph node palpation	0	—
Week 26: Lymph node palpation	151	—
Week 26: Lymph node palpation	0	—
Week 26: Lymph node palpation	0	—
Week -2: Musculoskeletal system	177	—
Week -2: Musculoskeletal system	0	—
Week -2: Musculoskeletal system	3	—
Week 26: Musculoskeletal system	149	—
Week 26: Musculoskeletal system	0	—
Week 26: Musculoskeletal system	2	—
Week-2: Respiratory system	180	—
Week-2: Respiratory system	0	—
Week-2: Respiratory system	0	—
Week 26: Respiratory system	151	—
Week 26: Respiratory system	0	—
Week 26: Respiratory system	0	—
week -2: Skin	156	—
week -2: Skin	20	—
week -2: Skin	4	—
Week 26: Skin	134	—
Week 26: Skin	15	—
Week 26: Skin	2	—
Week -2: Thyroid gland	179	—
Week -2: Thyroid gland	1	—
Week -2: Thyroid gland	0	—
Week 26: Thyroid gland	151	—
Week 26: Thyroid gland	0	—
Week 26: Thyroid gland	0	—

Secondary/registry result

Eye Examination

Time frame:Week -2, Week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek -2: Left eye	222	—
Week -2: Left eye	45	—
Week -2: Left eye	91	—
Week 26: Left eye	217	—
Week 26: Left eye	39	—
Week 26: Left eye	85	—
Week -2: Right eye	230	—
Week -2: Right eye	42	—
Week -2: Right eye	86	—
Week 26: Right eye	217	—
Week 26: Right eye	40	—
Week 26: Right eye	84	—
Insulin DegludecWeek -2: Left eye	109	—
Week -2: Left eye	14	—
Week -2: Left eye	52	—
Week 26: Left eye	99	—
Week 26: Left eye	20	—
Week 26: Left eye	48	—
Week -2: Right eye	112	—
Week -2: Right eye	16	—
Week -2: Right eye	47	—
Week 26: Right eye	103	—
Week 26: Right eye	23	—
Week 26: Right eye	41	—
LiraglutideWeek -2: Left eye	110	—
Week -2: Left eye	20	—
Week -2: Left eye	50	—
Week 26: Left eye	100	—
Week 26: Left eye	13	—
Week 26: Left eye	38	—
Week -2: Right eye	111	—
Week -2: Right eye	22	—
Week -2: Right eye	47	—
Week 26: Right eye	96	—
Week 26: Right eye	15	—
Week 26: Right eye	40	—

Secondary/registry result

Change in Electrocardiogram (ECG)

Time frame:Week -2, week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek -2	223	—
Week -2	94	—
Week -2	41	—
Week 26	227	—
Week 26	76	—
Week 26	38	—
Insulin DegludecWeek -2	109	—
Week -2	46	—
Week -2	20	—
Week 26	108	—
Week 26	47	—
Week 26	12	—
LiraglutideWeek -2	108	—
Week -2	52	—
Week -2	20	—
Week 26	87	—
Week 26	40	—
Week 26	24	—

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

Group	Value (mean), Units per liter (U/L)	95% CI
Insulin Degludec/LiraglutideAlkaline phosphatase	-2.0	—
ALT	-4.63	—
AST	-1.31	—
Creatine kinase	10.67	—
Amylase	9.84	—
Lipase	16.13	—
Insulin DegludecAlkaline phosphatase	-2.29	—
ALT	-6.17	—
AST	-2.65	—
Creatine kinase	15.37	—
Amylase	5.09	—
Lipase	-1.87	—
LiraglutideAlkaline phosphatase	-0.48	—
ALT	-2.81	—
AST	-0.99	—
Creatine kinase	0.52	—
Amylase	5.68	—
Lipase	14.11	—

Secondary/registry result

Change in Biochemistry Parameters (Albumin Serum, Total Protein)

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), 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 serum	0.04	—
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

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideCalcium serum (total)	-0.01	—
Calcium corrected serum	-0.00	—
Sodium serum	1.21	—
Urea serum	0.05	—
Potassium serum	-0.04	—
Insulin DegludecCalcium serum (total)	-0.02	—
Calcium corrected serum	-0.00	—
Sodium serum	0.98	—
Urea serum	0.03	—
Potassium serum	-0.09	—
LiraglutideCalcium serum (total)	-0.00	—
Calcium corrected serum	-0.01	—
Sodium serum	0.32	—
Urea serum	0.16	—
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

Group	Value (mean), micromoles per liter (umol/L)	95% CI
Insulin Degludec/LiraglutideTotal bilirubin	-0.78	—
creatinine serum	1.02	—
Insulin DegludecTotal bilirubin	-0.55	—
creatinine serum	1.36	—
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

Group	Value (mean), 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

Group	Value (mean), Percentage points (%) of red blood cells	95% 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

Group	Value (mean), % of eosinophils	95% CI
Insulin Degludec/Liraglutide	-0.06	—
Insulin Degludec	0.19	—
Liraglutide	0.11	—

Secondary/registry result

Change in Haematological Parameter - Neutrophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), % of neutrophils	95% CI
Insulin Degludec/Liraglutide	0.57	—
Insulin Degludec	0.18	—
Liraglutide	-0.53	—

Secondary/registry result

Change in Haematological Parameter: Basophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), % of basophils	95% 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

Group	Value (mean), % of monocytes	95% CI
Insulin Degludec/Liraglutide	-0.03	—
Insulin Degludec	0.01	—
Liraglutide	0.05	—

Secondary/registry result

Change in Haematological Parameter - Lymphocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), % of lymphocytes	95% CI
Insulin Degludec/Liraglutide	-0.46	—
Insulin Degludec	-0.38	—
Liraglutide	0.40	—

Secondary/registry result

Change in Haematology: Haemoglobin Blood

Time frame:Week 0, week 26

change from baseline, descriptive

LOINC 718-7

Posted result

Group	Value (mean), mmol/L	95% 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

Group	Value (mean), 10^9 cells per liter (10^9/L)	95% CI
Insulin Degludec/Liraglutide	0.25	—
Insulin Degludec	0.23	—
Liraglutide	-0.01	—

Secondary/registry result

Change in Haematological Parameter: Thrombocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), 10^9 cells per liter (10^9/L)	95% CI
Insulin Degludec/Liraglutide	8.19	—
Insulin Degludec	8.32	—
Liraglutide	4.32	—

Secondary/registry result

Change in Calcitonin

Time frame:Week 0, week 26

Thyroid event

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek 0	0	—
Week 0	351	—
Week 0	7	—
Week 26	0	—
Week 26	334	—
Week 26	6	—
Insulin DegludecWeek 0	0	—
Week 0	172	—
Week 0	3	—
Week 26	0	—
Week 26	165	—
Week 26	2	—
LiraglutideWeek 0	0	—
Week 0	178	—
Week 0	2	—
Week 26	0	—
Week 26	147	—
Week 26	3	—

Secondary/registry result

Urinalysis (Protein, Glucose, Erythrocytes and Ketones)

Time frame:Week 0, week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek 0: Erythrocytes	299	—
Week 0: Erythrocytes	36	—
Week 0: Erythrocytes	22	—
Week 26: Erythrocytes	297	—
Week 26: Erythrocytes	28	—
Week 26: Erythrocytes	14	—
Week 0: Glucose	253	—
Week 0: Glucose	35	—
Week 0: Glucose	69	—
Week 26: Glucose	322	—
Week 26: Glucose	11	—
Week 26: Glucose	6	—
Week 0: Ketones	325	—
Week 0: Ketones	25	—
Week 0: Ketones	7	—
Week 26: Ketones	334	—
Week 26: Ketones	4	—
Week 26: Ketones	1	—
Week 0: Protein	216	—
Week 0: Protein	86	—
Week 0: Protein	55	—
Week 26: Protein	254	—
Week 26: Protein	58	—
Week 26: Protein	27	—
Insulin DegludecWeek 0: Erythrocytes	153	—
Week 0: Erythrocytes	16	—
Week 0: Erythrocytes	6	—
Week 26: Erythrocytes	146	—
Week 26: Erythrocytes	16	—
Week 26: Erythrocytes	5	—
Week 0: Glucose	119	—
Week 0: Glucose	19	—
Week 0: Glucose	37	—
Week 26: Glucose	157	—
Week 26: Glucose	3	—
Week 26: Glucose	7	—
Week 0: Ketones	152	—
Week 0: Ketones	20	—
Week 0: Ketones	3	—
Week 26: Ketones	163	—
Week 26: Ketones	3	—
Week 26: Ketones	1	—
Week 0: Protein	104	—
Week 0: Protein	40	—
Week 0: Protein	31	—
Week 26: Protein	120	—
Week 26: Protein	26	—
Week 26: Protein	21	—
LiraglutideWeek 0: Erythrocytes	156	—
Week 0: Erythrocytes	16	—
Week 0: Erythrocytes	8	—
Week 26: Erythrocytes	136	—
Week 26: Erythrocytes	11	—
Week 26: Erythrocytes	4	—
Week 0: Glucose	123	—
Week 0: Glucose	18	—
Week 0: Glucose	39	—
Week 26: Glucose	131	—
Week 26: Glucose	5	—
Week 26: Glucose	15	—
Week 0: Ketones	167	—
Week 0: Ketones	11	—
Week 0: Ketones	2	—
Week 26: Ketones	141	—
Week 26: Ketones	10	—
Week 26: Ketones	0	—
Week 0: Protein	116	—
Week 0: Protein	37	—
Week 0: Protein	27	—
Week 26: Protein	105	—
Week 26: Protein	28	—
Week 26: Protein	18	—

Secondary/registry result

Occurence of Anti-insulin Degludec Specific Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Insulin Degludec/Liraglutide	0.22	—
Insulin Degludec	0.12	—

Secondary/registry result

Occurence of Antibodies Cross-reacting to Human Insulin

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Insulin Degludec/Liraglutide	6.61	—
Insulin Degludec	2.99	—

Secondary/registry result

Occurence of Total Insulin Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Insulin Degludec/Liraglutide	6.83	—
Insulin Degludec	3.11	—

Secondary/registry result

Occurence of Anti-liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	45	—
	287	—
Liraglutide	40	—
	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

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	6	—
Liraglutide	3	—

Secondary/registry result

Occurence of Neutralising Liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	9	—
Liraglutide	8	—

Secondary/registry result

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

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	0	—
Liraglutide	0	—

Secondary/registry result

Serum Concentrations of Insulin Degludec

Time frame:Week 0, week 26

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), pmol/L	95% CI
Insulin Degludec/Liraglutide	3583	—
Insulin Degludec	4133	—

Secondary/registry result

Plasma Concentration of Liraglutide

Time frame:Week 0, week 26

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pmol/L	95% CI
Insulin Degludec/Liraglutide	9963	—
Liraglutide	21602	—

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

DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs.
Journal of diabetes2022 Jun (month)PMID35762390doi:10.1111/1753-0407.13286via CT.gov reference

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.