DUAL™ II China

CompletedPhase 3Results posted

A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

453

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT03175120

Org study IDNN9068-4166

Secondary IDCTR20060909China Drug Trials (China)

Secondary IDU1111-1154-6732World Health Organization (WHO)

Timeline

Milestones

Study start2017-05-26actual

Study first posted2017-06-05actual

Primary completion2019-03-05actual

Study completion2019-04-04actual

Last update posted2020-03-19actual

Results first posted2020-03-19actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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 procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - 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 glinide (at least 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 (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m^2 Exclusion Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - 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 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - History of pancreatitis (acute or chronic)

Endpoints (122)

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

Other (unclassified)

Weight & body composition

Renal / kidney

Other clinical outcomes

MASH / liver

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	-0.7	—
Insulin Degludec	0.5	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Insulin Degludec/Liraglutide	-0.4	—
Insulin Degludec	0.7	—

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 Circumference

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 point of HbA1c	95% CI
Insulin Degludec/Liraglutide	-1.93	—
Insulin Degludec	-1.06	—

Treatment contrast-0.9295% CI-1.09 – -0.75p<.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

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	-3.57	—
Insulin Degludec	-2.82	—

Secondary/registry result

Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-3.35	—
Insulin Degludec	-2.31	—

Secondary/registry result

Change in SMPG-mean Post Prandial 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	0.08	—
Insulin Degludec	0.28	—

Secondary/registry result/low confidence

Insulin Dose

Time frame:Week 26

descriptive

Posted result

Group	Value (mean), Units of insulin (U)	95% CI
Insulin Degludec/Liraglutide	34.6	—
Insulin Degludec	37.9	—

Secondary/registry result

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

Time frame:Week 26

descriptive, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideBefore breakfast	5.48	—
90 minutes after start of breakfast	9.51	—
Before lunch	6.93	—
90 minutes after start of lunch	9.68	—
Before main evening meal	7.24	—
90 minutes after main evening meal	9.87	—
At bedtime	8.57	—
At 4:00 a.m.	5.97	—
Before breakfast the following day	5.48	—
Insulin DegludecBefore breakfast	5.88	—
90 minutes after start of breakfast	10.50	—
Before lunch	8.17	—
90 minutes after start of lunch	11.21	—
Before main evening meal	7.87	—
90 minutes after main evening meal	10.86	—
At bedtime	9.52	—
At 4:00 a.m.	6.61	—
Before breakfast the following day	5.83	—

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 C-peptide	95% CI
Insulin Degludec/Liraglutide	0.64	—
Insulin Degludec	0.52	—

Secondary/registry result

Change in Fasting Insulin- Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of insulin	95% CI
Insulin Degludec/Liraglutide	0.63	—
Insulin Degludec	0.50	—

Secondary/registry result/low confidence

Change in Fasting Glucagon- Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of glucagon	95% CI
Insulin Degludec/Liraglutide	1.01	—
Insulin Degludec	1.09	—

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 beta-cell function	95% CI
Insulin Degludec/Liraglutide	1.47	—
Insulin Degludec	0.99	—

Secondary/registry result

Participants Who Achieved HbA1c < 7.0%, 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	151	—
	138	—
Insulin Degludec	23	—
	115	—

Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) 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	96	—
	193	—
Insulin Degludec	10	—
	128	—

Secondary/registry result

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

Time frame:Week 26

HbA1c BW composite responder

composite event, improvement

componentsHbA1c < 7.0% (threshold achievement), Change from baseline in body weight <= 0 (threshold achievement)

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	98	—
	204	—
Insulin Degludec	7	—
	144	—

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

composite event, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	59	—
	243	—
Insulin Degludec	3	—
	148	—

Secondary/registry result

Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or 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	148	—
	154	—
Insulin Degludec	22	—
	129	—

Secondary/registry result

Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent 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	93	—
	209	—
Insulin Degludec	9	—
	142	—

Secondary/registry result

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

Time frame:Week 26

threshold achievement, improvement

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

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	94	—
	208	—
Insulin Degludec	7	—
	144	—

Secondary/registry result

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

Time frame:Week 26

threshold achievement, improvement

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

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	58	—
	244	—
Insulin Degludec	3	—
	148	—

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

Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in SMPG-mean Post Prandial Increments

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin Dose

Time frame:Week 26

descriptive

Secondary/protocol endpoint

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

Time frame:Week 26

descriptive

Secondary/protocol endpoint

Change in Fasting C-peptide- Ratio to Baseline

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Change in Fasting 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

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

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Participants Who Achieved HbA1c < 7.0%, 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%, American Association of Clinical Endocrinologists (AACE) 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 From Baseline in Body Weight 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 Treatment-emergent Severe or 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 Treatment-emergent 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% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Week 26

threshold achievement, improvement

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

Secondary/protocol endpoint

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

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

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

LOINC 4548-4

MASH / liver

1 endpoint

Secondary/registry result

Change in Total Bilirubin

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), Micromoles per liter (umol/L)	95% CI
Insulin Degludec/Liraglutide	-0.30	—
Insulin Degludec	-0.54	—

Renal / kidney

3 endpoints

Secondary/registry result

Change in Albumin

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), Grams per deciliter (g/dL)	95% CI
Insulin Degludec/Liraglutide	0.05	—
Insulin Degludec	0.02	—

Secondary/registry result

Change in Creatinine

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), umol/L	95% CI
Insulin Degludec/Liraglutide	0.44	—
Insulin Degludec	-0.32	—

Secondary/protocol endpoint

Change in Creatinine

Time frame:Week 0, week 26

change from baseline, improvement

Cardiometabolic biomarkers

16 endpoints

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 HDL cholesterol	95% CI
Insulin Degludec/Liraglutide	1.00	—
Insulin Degludec	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 LDL cholesterol	95% CI
Insulin Degludec/Liraglutide	0.89	—
Insulin Degludec	0.95	—

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 VLDL cholesterol	95% CI
Insulin Degludec/Liraglutide	0.92	—
Insulin Degludec	0.93	—

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 total cholesterol	95% CI
Insulin Degludec/Liraglutide	0.92	—
Insulin Degludec	0.97	—

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 triglycerides	95% CI
Insulin Degludec/Liraglutide	0.91	—
Insulin Degludec	0.92	—

Secondary/registry result

Change in Fasting Free Fatty Acids- Ratio to Baseline

Time frame:Week 0, week 26

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Insulin Degludec/Liraglutide	0.65	—
Insulin Degludec	0.64	—

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 minute (beats/min)	95% CI
Insulin Degludec/Liraglutide	5.7	—
Insulin Degludec	1.3	—

Secondary/registry result

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

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Insulin Degludec/LiraglutideSystolic blood pressure	-3.5	—
Diastolic blood pressure	0.1	—
Insulin DegludecSystolic blood pressure	-0.5	—
Diastolic blood pressure	-0.4	—

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 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 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 Acids- 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

55 endpoints

Secondary/registry result

Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Time frame:Up to 26 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	38	—
Insulin Degludec	36	—

Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Weeks 0-27

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Adverse events	95% CI
Insulin Degludec/Liraglutide	641	—
Insulin Degludec	230	—

Secondary/registry result

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Weeks 0-27

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	9	—
Insulin Degludec	8	—

Secondary/registry result

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

Time frame:Weeks 0-27

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	23	—
Insulin Degludec	21	—

Secondary/registry result

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

Time frame:Weeks 0-27

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	7	—
Insulin Degludec	7	—

Secondary/registry result

Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition

Time frame:Weeks 0-27

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	1099	—
Insulin Degludec	680	—

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	299	—
Week-2: Cardiovascular system	1	—
Week-2: Cardiovascular system	1	—
Week 26: Cardiovascular system	286	—
Week 26: Cardiovascular system	1	—
Week 26: Cardiovascular system	1	—
Week-2: Central and peripheral nervous system	299	—
Week-2: Central and peripheral nervous system	2	—
Week-2: Central and peripheral nervous system	0	—
Week 26: Central and peripheral nervous system	287	—
Week 26: Central and peripheral nervous system	1	—
Week 26: Central and peripheral nervous system	0	—
Week -2: Gastrointestinal system	299	—
Week -2: Gastrointestinal system	2	—
Week -2: Gastrointestinal system	0	—
Week 26: Gastrointestinal system	285	—
Week 26: Gastrointestinal system	2	—
Week 26: Gastrointestinal system	1	—
Week -2: General appearance	283	—
Week -2: General appearance	11	—
Week -2: General appearance	7	—
Week 26: General appearance	273	—
Week 26: General appearance	9	—
Week 26: General appearance	6	—
Week -2: Head, eyes, ENTand Neck	295	—
Week -2: Head, eyes, ENTand Neck	2	—
Week -2: Head, eyes, ENTand Neck	4	—
Week 26: Head, eyes, ENTand Neck	283	—
Week 26: Head, eyes, ENTand Neck	2	—
Week 26: Head, eyes, ENTand Neck	3	—
Week -2: Lymph node palpation	301	—
Week -2: Lymph node palpation	0	—
Week -2: Lymph node palpation	0	—
Week 26: Lymph node palpation	288	—
Week 26: Lymph node palpation	0	—
Week 26: Lymph node palpation	0	—
Week -2: Musculoskeletal system	296	—
Week -2: Musculoskeletal system	2	—
Week -2: Musculoskeletal system	3	—
Week 26: Musculoskeletal system	280	—
Week 26: Musculoskeletal system	3	—
Week 26: Musculoskeletal system	5	—
Week -2: Respiratory system	301	—
Week -2: Respiratory system	0	—
Week -2: Respiratory system	0	—
Week 26: Respiratory system	288	—
Week 26: Respiratory system	0	—
Week 26: Respiratory system	0	—
Week -2: Skin	270	—
Week -2: Skin	22	—
Week -2: Skin	9	—
Week 26: Skin	259	—
Week 26: Skin	22	—
Week 26: Skin	7	—
Week -2: Thyroid gland	295	—
Week -2: Thyroid gland	4	—
Week -2: Thyroid gland	2	—
Week 26: Thyroid gland	284	—
Week 26: Thyroid gland	3	—
Week 26: Thyroid gland	1	—
Insulin DegludecWeek-2: Cardiovascular system	149	—
Week-2: Cardiovascular system	0	—
Week-2: Cardiovascular system	2	—
Week 26: Cardiovascular system	137	—
Week 26: Cardiovascular system	0	—
Week 26: Cardiovascular system	2	—
Week-2: Central and peripheral nervous system	150	—
Week-2: Central and peripheral nervous system	0	—
Week-2: Central and peripheral nervous system	1	—
Week 26: Central and peripheral nervous system	139	—
Week 26: Central and peripheral nervous system	0	—
Week 26: Central and peripheral nervous system	0	—
Week -2: Gastrointestinal system	150	—
Week -2: Gastrointestinal system	1	—
Week -2: Gastrointestinal system	0	—
Week 26: Gastrointestinal system	139	—
Week 26: Gastrointestinal system	0	—
Week 26: Gastrointestinal system	0	—
Week -2: General appearance	141	—
Week -2: General appearance	2	—
Week -2: General appearance	8	—
Week 26: General appearance	130	—
Week 26: General appearance	2	—
Week 26: General appearance	7	—
Week -2: Head, eyes, ENTand Neck	147	—
Week -2: Head, eyes, ENTand Neck	2	—
Week -2: Head, eyes, ENTand Neck	2	—
Week 26: Head, eyes, ENTand Neck	137	—
Week 26: Head, eyes, ENTand Neck	1	—
Week 26: Head, eyes, ENTand Neck	1	—
Week -2: Lymph node palpation	151	—
Week -2: Lymph node palpation	0	—
Week -2: Lymph node palpation	0	—
Week 26: Lymph node palpation	139	—
Week 26: Lymph node palpation	0	—
Week 26: Lymph node palpation	0	—
Week -2: Musculoskeletal system	145	—
Week -2: Musculoskeletal system	3	—
Week -2: Musculoskeletal system	3	—
Week 26: Musculoskeletal system	137	—
Week 26: Musculoskeletal system	1	—
Week 26: Musculoskeletal system	1	—
Week -2: Respiratory system	151	—
Week -2: Respiratory system	0	—
Week -2: Respiratory system	0	—
Week 26: Respiratory system	139	—
Week 26: Respiratory system	0	—
Week 26: Respiratory system	0	—
Week -2: Skin	132	—
Week -2: Skin	13	—
Week -2: Skin	6	—
Week 26: Skin	126	—
Week 26: Skin	9	—
Week 26: Skin	4	—
Week -2: Thyroid gland	147	—
Week -2: Thyroid gland	2	—
Week -2: Thyroid gland	2	—
Week 26: Thyroid gland	134	—
Week 26: Thyroid gland	3	—
Week 26: Thyroid gland	2	—

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	175	—
Week -2	76	—
Week -2	50	—
Week 26	175	—
Week 26	73	—
Week 26	39	—
Insulin DegludecWeek -2	90	—
Week -2	41	—
Week -2	20	—
Week 26	91	—
Week 26	32	—
Week 26	16	—

Secondary/registry result

Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)

Time frame:Week 0, week 26

change from baseline, descriptive

componentsamylase change, lipase change, creatine kinase change, ALT, change, AST, change, alkaline phosphatase change

Posted result

Group	Value (mean), Units per liter (U/L)	95% CI
Insulin Degludec/LiraglutideAmylase	10.45	—
Lipase	16.97	—
Creatinine kinase	3.32	—
ALT	-3.02	—
AST	-1.42	—
ALP	-1.62	—
Insulin DegludecAmylase	2.69	—
Lipase	-0.35	—
Creatinine kinase	6.99	—
ALT	-4.06	—
AST	-2.06	—
ALP	-1.70	—

Secondary/registry result

Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideCalcium (total)	0.01	—
Albumin corrected calcium	-0.00	—
Potassium	-0.03	—
Sodium	1.03	—
Urea	-0.09	—
Insulin DegludecCalcium (total)	-0.01	—
Albumin corrected calcium	-0.01	—
Potassium	-0.11	—
Sodium	1.40	—
Urea	0.17	—

Secondary/registry result

Change in Total Protein

Time frame:Week 0, week 26

total protein

change from baseline, descriptive

Posted result

Group	Value (mean), g/dL	95% CI
Insulin Degludec/Liraglutide	0.08	—
Insulin Degludec	0.03	—

Secondary/registry result

Change in Haematological Parameter- Haematocrit

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of red blood cells	95% CI
Insulin Degludec/Liraglutide	-0.07	—
Insulin Degludec	-0.12	—

Secondary/registry result

Change in Haematological Parameter- Haemoglobin

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-0.08	—
Insulin Degludec	-0.09	—

Secondary/registry result

Change in Haematological Parameter- Leukocytes and 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/LiraglutideLeukocytes	0.32	—
Thrombocytes	14.13	—
Insulin DegludecLeukocytes	0.31	—
Thrombocytes	12.19	—

Secondary/registry result

Change in Haematological Parameter- Erythrocytes

Time frame:Week 0, week 26

erythrocytes rbc

change from baseline, descriptive

Posted result

Group	Value (mean), 10^12 cells per liter (10^12/L)	95% CI
Insulin Degludec/Liraglutide	-0.06	—
Insulin Degludec	-0.05	—

Secondary/registry result

Change in Haematological Parameter- Basophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of basophils	95% CI
Insulin Degludec/Liraglutide	0.00	—
Insulin Degludec	0.01	—

Secondary/registry result

Change in Haematological Parameter- Eosinophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of eosinophils	95% CI
Insulin Degludec/Liraglutide	-0.15	—
Insulin Degludec	-0.25	—

Secondary/registry result

Change in Haematological Parameter- Lymphocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of lymphocytes	95% CI
Insulin Degludec/Liraglutide	-1.00	—
Insulin Degludec	-0.82	—

Secondary/registry result

Change in Haematological Parameter- Monocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

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

Secondary/registry result

Change in Haematological Parameter- Neutrophils

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of neutrophils	95% CI
Insulin Degludec/Liraglutide	1.34	—
Insulin Degludec	0.99	—

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	293	—
Week 0	8	—
Week 26	0	—
Week 26	279	—
Week 26	10	—
Insulin DegludecWeek 0	0	—
Week 0	149	—
Week 0	2	—
Week 26	0	—
Week 26	136	—
Week 26	3	—

Secondary/registry result

Urinalysis (Erythrocytes, Protein, Glucose and Ketones)

Time frame:Week 0, week 26

categorical status, descriptive

componentsurine erythrocytes, urine protein, urine glucose, urine ketones

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideWeek 0: Erythrocytes	258	—
Week 0: Erythrocytes	33	—
Week 0: Erythrocytes	3	—
Week 0: Erythrocytes	2	—
Week 0: Erythrocytes	4	—
Week 26: Erythrocytes	255	—
Week 26: Erythrocytes	22	—
Week 26: Erythrocytes	6	—
Week 26: Erythrocytes	2	—
Week 26: Erythrocytes	2	—
Week 0: Glucose	171	—
Week 0: Glucose	33	—
Week 0: Glucose	30	—
Week 0: Glucose	25	—
Week 0: Glucose	41	—
Week 26: Glucose	256	—
Week 26: Glucose	14	—
Week 26: Glucose	10	—
Week 26: Glucose	4	—
Week 26: Glucose	3	—
Week 0: Ketones	274	—
Week 0: Ketones	21	—
Week 0: Ketones	5	—
Week 0: Ketones	0	—
Week 0: Ketones	0	—
Week 26: Ketones	272	—
Week 26: Ketones	14	—
Week 26: Ketones	1	—
Week 26: Ketones	0	—
Week 26: Ketones	0	—
Week 0: Protein	172	—
Week 0: Protein	72	—
Week 0: Protein	36	—
Week 0: Protein	16	—
Week 0: Protein	4	—
Week 26: Protein	198	—
Week 26: Protein	47	—
Week 26: Protein	29	—
Week 26: Protein	11	—
Week 26: Protein	2	—
Insulin DegludecWeek 0: Erythrocytes	121	—
Week 0: Erythrocytes	22	—
Week 0: Erythrocytes	4	—
Week 0: Erythrocytes	3	—
Week 0: Erythrocytes	1	—
Week 26: Erythrocytes	120	—
Week 26: Erythrocytes	11	—
Week 26: Erythrocytes	1	—
Week 26: Erythrocytes	4	—
Week 26: Erythrocytes	3	—
Week 0: Glucose	92	—
Week 0: Glucose	13	—
Week 0: Glucose	17	—
Week 0: Glucose	13	—
Week 0: Glucose	16	—
Week 26: Glucose	110	—
Week 26: Glucose	16	—
Week 26: Glucose	9	—
Week 26: Glucose	2	—
Week 26: Glucose	2	—
Week 0: Ketones	137	—
Week 0: Ketones	10	—
Week 0: Ketones	4	—
Week 0: Ketones	0	—
Week 0: Ketones	0	—
Week 26: Ketones	132	—
Week 26: Ketones	7	—
Week 26: Ketones	0	—
Week 26: Ketones	0	—
Week 26: Ketones	0	—
Week 0: Protein	89	—
Week 0: Protein	32	—
Week 0: Protein	18	—
Week 0: Protein	10	—
Week 0: Protein	2	—
Week 26: Protein	89	—
Week 26: Protein	22	—
Week 26: Protein	18	—
Week 26: Protein	9	—
Week 26: Protein	1	—

Secondary/registry result

Anti-insulin Degludec Specific Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Insulin Degludec/Liraglutide	0.25	—
Insulin Degludec	0.13	—

Secondary/registry result

Antibodies Cross-reacting to Human Insulin

Time frame:Week 27

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Insulin Degludec/Liraglutide	9.07	—
Insulin Degludec	8.64	—

Secondary/registry result

Total Insulin Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Insulin Degludec/Liraglutide	9.31	—
Insulin Degludec	8.77	—

Secondary/registry result

Occurrence of Anti-liraglutide Antibodies (Yes/no)

Time frame:Week 27

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/Liraglutide	24	—
	264	—

Secondary/registry result

Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (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	—

Secondary/registry result

Occurrence 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	0	—

Secondary/registry result

Occurrence of Neutralising Liraglutide Antibodies Cross Reacting 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	—

Secondary/protocol endpoint

Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

Time frame:Up to 26 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Weeks 0-27

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes

Time frame:Weeks 0-27

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 0-27

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 0-27

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 0-27

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 Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Haemoglobin

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Leukocytes and Thrombocytes

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change in Haematological Parameter- Erythrocytes

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- Eosinophils

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 Haematological Parameter- Neutrophils

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 (Erythrocytes, Protein, Glucose and Ketones)

Time frame:Week 0, week 26

categorical status, descriptive

Secondary/protocol endpoint

Anti-insulin Degludec Specific Antibodies

Time frame:Week 27

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Antibodies Cross-reacting to Human Insulin

Time frame:Week 27

descriptive

Secondary/protocol endpoint

Total Insulin Antibodies

Time frame:Week 27

descriptive

Secondary/protocol endpoint

Occurrence of Anti-liraglutide Antibodies (Yes/no)

Time frame:Week 27

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Occurrence of Neutralising Liraglutide Antibodies

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1

Time frame:Week 27

Immunogenicity (ADA)

threshold achievement, event

Other clinical outcomes

2 endpoints

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	167	—
Week -2: Left eye	34	—
Week -2: Left eye	100	—
Week 26: Left eye	147	—
Week 26: Left eye	35	—
Week 26: Left eye	105	—
Week -2: Right eye	162	—
Week -2: Right eye	41	—
Week -2: Right eye	98	—
Week 26: Right eye	139	—
Week 26: Right eye	37	—
Week 26: Right eye	111	—
Insulin DegludecWeek -2: Left eye	87	—
Week -2: Left eye	15	—
Week -2: Left eye	49	—
Week 26: Left eye	80	—
Week 26: Left eye	14	—
Week 26: Left eye	45	—
Week -2: Right eye	85	—
Week -2: Right eye	18	—
Week -2: Right eye	47	—
Week 26: Right eye	84	—
Week 26: Right eye	12	—
Week 26: Right eye	42	—

Secondary/protocol endpoint

Eye Examination

Time frame:Week -2, week 26

categorical status, descriptive

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

Change in Albumin

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Total Bilirubin

Time frame:Week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Total Protein

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Haematological Parameter- Haematocrit

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Haematological Parameter- Monocytes

Time frame:Week 0, week 26

change from baseline, descriptive

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.