DUAL™ I Japan

CompletedPhase 3Results posted

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

819

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-11%

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 IDNCT02607306

Org study IDNN9068-4183

Secondary IDJapicCTI-153089JAPIC

Secondary IDU1111-1170-1332WHO

Timeline

Milestones

Study first posted2015-11-18estimated

Study start2015-11-18actual

Primary completion2017-12-15actual

Study completion2017-12-22actual

Results first posted2019-07-29actual

Last update posted2021-04-09actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female Japanese subjects, age at least 20 years at the time of signing informed consent

•Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

•HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%

•Body-mass index (BMI) above or equal to 20 kg/m^2

•Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling

Exclusion criteria

•Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening

•Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism

•Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal

•Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

•Screening calcitonin equal to or above 50 ng/L

•History of pancreatitis (acute or chronic)

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)

•Subjects presently classified as being in New York Heart Association (NYHA) Class IV

Endpoints (80)

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

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

Other clinical outcomes

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight (kg)

Time frame:Week 0, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Insulin Degludec/Liraglutide	2.9	—
Insulin Degludec	4.1	—
Liraglutide	-1.0	—

Treatment contrast-1.1995% CI-1.80 – -0.59p0.0001ANCOVA

The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Cm	95% CI
Insulin Degludec/Liraglutide	2.5	—
Insulin Degludec	3.4	—
Liraglutide	-1.1	—

Secondary/protocol endpoint

Change From Baseline in Body Weight (kg)

Time frame:Week 0, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, Week 52

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

36 endpoints

Primary/registry result

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Insulin Degludec/Liraglutide	-2.42	—
Insulin Degludec	-1.80	—
Liraglutide	-1.80	—

Treatment contrast-0.6395% CI-0.75 – -0.52p<0.0001ANCOVA

The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.

Treatment contrast-0.4895% CI-0.60 – -0.37p<0.0001ANCOVA

The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.

Primary/protocol endpoint

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Insulin Degludec/Liraglutide	-2.42	—
Insulin Degludec	-1.80	—
Liraglutide	-1.80	—

Treatment contrast-0.6395% CI-0.75 – -0.52p<0.0001ANCOVA

The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-4.08	—
Insulin Degludec	-3.97	—
Liraglutide	-2.62	—

Secondary/registry result/low confidence

Insulin Dose

Time frame:After 52 weeks of treatment

descriptive

Posted result

Group	Value (mean), Insulin Units/Day	95% CI
Insulin Degludec/Liraglutide	27.7	—
Insulin Degludec	34.8	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 7.0%

Time frame:After 52 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	245	—
No	30	—
Insulin DegludecYes	189	—
No	82	—
LiraglutideYes	208	—
No	65	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero

Time frame:After 52 weeks of treatment

threshold achievement, improvement

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

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	44	—
No	231	—
Insulin DegludecYes	22	—
No	249	—
LiraglutideYes	142	—
No	131	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

Time frame:After 52 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	227	—
No	43	—
Insulin DegludecYes	169	—
No	96	—
LiraglutideYes	206	—
No	65	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

Time frame:After 52 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	37	—
No	233	—
Insulin DegludecYes	22	—
No	243	—
LiraglutideYes	141	—
No	130	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 6.5%

Time frame:After 52 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	213	—
No	62	—
Insulin DegludecYes	134	—
No	137	—
LiraglutideYes	171	—
No	102	—

Secondary/registry result/low confidence

Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero

Time frame:After 52 weeks of treatment

threshold achievement, improvement

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

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	41	—
No	234	—
Insulin DegludecYes	17	—
No	254	—
LiraglutideYes	126	—
No	147	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

Time frame:After 52 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	198	—
No	72	—
Insulin DegludecYes	123	—
No	142	—
LiraglutideYes	170	—
No	101	—

Secondary/registry result

Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

Time frame:After 52 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideYes	35	—
No	235	—
Insulin DegludecYes	17	—
No	248	—
LiraglutideYes	125	—
No	146	—

Secondary/registry result

Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)

Time frame:After 52 weeks of the treatment

descriptive, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/LiraglutideBefore breakfast	5.90	—
90 minutes after start of breakfast	9.57	—
Before lunch	6.01	—
90 minutes after start of lunch	9.85	—
Before dinner	6.47	—
90 minutes after start of dinner	9.67	—
Bedtime	8.27	—
At 4:00 a.m.	6.12	—
Before breakfast the following day	5.77	—
Insulin DegludecBefore breakfast	5.93	—
90 minutes after start of breakfast	10.43	—
Before lunch	6.72	—
90 minutes after start of lunch	11.12	—
Before dinner	6.90	—
90 minutes after start of dinner	10.89	—
Bedtime	9.49	—
At 4:00 a.m.	6.41	—
Before breakfast the following day	5.71	—
LiraglutideBefore breakfast	7.35	—
90 minutes after start of breakfast	10.59	—
Before lunch	6.87	—
90 minutes after start of lunch	10.59	—
Before dinner	7.03	—
90 minutes after start of dinner	10.14	—
Bedtime	8.73	—
At 4:00 a.m.	7.27	—
Before breakfast the following day	7.13	—

Secondary/registry result

Change in SMBG 9-point Profile - Mean of the 9-point Profile

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-4.60	—
Insulin Degludec	-3.84	—
Liraglutide	-3.46	—

Secondary/registry result

Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide	-0.74	—
Insulin Degludec	-0.27	—
Liraglutide	-1.01	—

Secondary/registry result

Fasting C-peptide as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.61	—
Insulin Degludec	0.42	—
Liraglutide	1.12	—

Secondary/registry result

Fasting Human Insulin as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.90	—
Insulin Degludec	0.61	—
Liraglutide	1.52	—

Secondary/registry result/low confidence

Proinsulin as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.18	—
Insulin Degludec	0.17	—
Liraglutide	0.59	—

Secondary/protocol endpoint

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg

Time frame:Week 0, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Insulin Dose

Time frame:After 52 weeks of treatment

descriptive

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 7.0%

Time frame:After 52 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero

Time frame:After 52 weeks of treatment

threshold achievement, improvement

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

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

Time frame:After 52 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:After 52 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 6.5%

Time frame:After 52 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero

Time frame:After 52 weeks of treatment

threshold achievement, improvement

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

Secondary/protocol endpoint

Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.

Time frame:After 52 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:After 52 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)

Time frame:After 52 weeks of the treatment

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Change in SMBG 9-point Profile - Mean of the 9-point Profile

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Fasting C-peptide as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

Fasting Human Insulin as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Secondary/protocol endpoint/low confidence

Proinsulin as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Cardiometabolic biomarkers

17 endpoints

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic)

Time frame:Week 0, Week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Insulin Degludec/LiraglutideSystolic blood pressure	1.7	—
Diastolic blood pressure	0.5	—
Insulin DegludecSystolic blood pressure	3.4	—
Diastolic blood pressure	0.6	—
LiraglutideSystolic blood pressure	-1.8	—
Diastolic blood pressure	-0.4	—

Secondary/registry result

Total Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.92	—
Insulin Degludec	0.97	—
Liraglutide	0.94	—

Secondary/registry result

Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.91	—
Insulin Degludec	0.99	—
Liraglutide	0.93	—

Secondary/registry result

High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.94	—
Insulin Degludec	0.94	—
Liraglutide	0.99	—

Secondary/registry result

Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.92	—
Insulin Degludec	0.97	—
Liraglutide	0.91	—

Secondary/registry result

Triglycerides as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.91	—
Insulin Degludec	0.96	—
Liraglutide	0.91	—

Secondary/registry result

Free Fatty Acids as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.74	—
Insulin Degludec	0.70	—
Liraglutide	0.93	—

Secondary/registry result

Fasting Glucagon as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

fasting glucagon ratio to baseline

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Insulin Degludec/Liraglutide	0.95	—
Insulin Degludec	0.94	—
Liraglutide	0.96	—

Secondary/registry result

Change in Clinical Evaluation: Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute	95% CI
Insulin Degludec/Liraglutide	3.9	—
Insulin Degludec	0.8	—
Liraglutide	4.2	—

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic)

Time frame:Week 0, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Total Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Triglycerides as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Free Fatty Acids as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Clinical Evaluation: Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

21 endpoints

Secondary/registry result

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

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	467	—
Insulin Degludec	869	—
Liraglutide	13	—

Treatment contrast0.4895% CI0.35 – 0.68p<0.0001Negative binomial regression

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:0-52 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Insulin Degludec/Liraglutide	873	—
Insulin Degludec	829	—
Liraglutide	885	—

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:0-52 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	135	—
Insulin Degludec	362	—
Liraglutide	136	—

Secondary/registry result

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

Time frame:0-52 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	16	—
Insulin Degludec	42	—
Liraglutide	0	—

Secondary/registry result

Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

Time frame:0-52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Insulin Degludec/Liraglutide	4830	—
Insulin Degludec	6340	—
Liraglutide	162	—

Secondary/registry result

Anti-drug Antibodies: Anti-insulin Degludec Antibodies

Time frame:at week 52

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), Percentage B/T	95% CI
Insulin Degludec/Liraglutide	0.12	—
Insulin Degludec	-0.11	—

Secondary/registry result

Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies

Time frame:at week 52

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideNegative	247	—
Positive	28	—
LiraglutideNegative	224	—
Positive	49	—

Secondary/registry result

Change in Clinical Evaluation: Electrocardiogram (ECG)

Time frame:at screening (week -2 to week 0), at week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideAt screening visit - normal	228	—
At screening visit - Abn, NCS	40	—
At screening visit - Abn, CS	7	—
Week 52 - normal	238	—
Week 52 - Abn, NCS	30	—
Week 52 - Abn, CS	7	—
Insulin DegludecAt screening visit - normal	230	—
At screening visit - Abn, NCS	38	—
At screening visit - Abn, CS	3	—
Week 52 - normal	232	—
Week 52 - Abn, NCS	35	—
Week 52 - Abn, CS	4	—
LiraglutideAt screening visit - normal	222	—
At screening visit - Abn, NCS	41	—
At screening visit - Abn, CS	10	—
Week 52 - normal	233	—
Week 52 - Abn, NCS	34	—
Week 52 - Abn, CS	6	—

Secondary/registry result

Serum Concentrations of Insulin Degludec

Time frame:Weeks 2, 8, 16, 26, 44, 52

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pmol/L	95% CI
Insulin Degludec/LiraglutideAt week 2	1468.7	—
At week 8	2246.0	—
At week 16	2511.0	—
At week 26	2597.3	—
At week 44	2766.6	—
At week 52	2393.8	—
Insulin DegludecAt week 2	1477.1	—
At week 8	2524.6	—
At week 16	2856.4	—
At week 26	2946.9	—
At week 44	3238.8	—
At week 52	3124.4	—

Secondary/registry result

Plasma Concentrations of Liraglutide

Time frame:Weeks 2, 8, 16, 26, 44, 52

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), pmol/L	95% CI
Insulin Degludec/LiraglutideAt week 2	5681.3	—
At week 8	9107.8	—
At week 16	10038.1	—
At week 26	9995.3	—
At week 44	8791.7	—
At week 52	7426.2	—
LiraglutideAt week 2	6081.6	—
At week 8	14539.5	—
At week 16	14046.5	—
At week 26	13904.2	—
At week 44	12855.6	—
At week 52	12127.4	—

Secondary/protocol endpoint

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

Time frame:Weeks 0-52

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:0-52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:0-52 weeks

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:0-52 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition

Time frame:0-52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Anti-drug Antibodies: Anti-insulin Degludec Antibodies

Time frame:at week 52

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies

Time frame:at week 52

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Change in Clinical Evaluation: Fundoscopy or Fundus Photography

Time frame:at screening (week -2 to week 0), at week 52

categorical status, event

Secondary/protocol endpoint

Change in Clinical Evaluation: Electrocardiogram (ECG)

Time frame:at screening (week -2 to week 0), at week 52

categorical status, descriptive

Secondary/protocol endpoint

Serum Concentrations of Insulin Degludec

Time frame:Weeks 2, 8, 16, 26, 44, 52

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Plasma Concentrations of Liraglutide

Time frame:Weeks 2, 8, 16, 26, 44, 52

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

1 endpoint

Secondary/registry result

Change in Clinical Evaluation: Fundoscopy or Fundus Photography

Time frame:at screening (week -2 to week 0), at week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Insulin Degludec/LiraglutideLeft eye - at screening visit - normal	225	—
Left eye - at screening visit - Abn, NCS	10	—
Left eye - at screening visit - Abn, CS	39	—
Left eye - week 52 - normal	217	—
Left eye - week 52 - Abn, NCS	17	—
Left eye - week 52 - Abn, CS	40	—
Right eye - at screening visit - normal	224	—
Right eye - at screening visit - Abn, NCS	10	—
Right eye - at screening visit - Abn, CS	41	—
Right eye - week 52 - normal	220	—
Right eye - week 52 - Abn, NCS	14	—
Right eye - week 52 - Abn, CS	41	—
Insulin DegludecLeft eye - at screening visit - normal	213	—
Left eye - at screening visit - Abn, NCS	16	—
Left eye - at screening visit - Abn, CS	42	—
Left eye - week 52 - normal	214	—
Left eye - week 52 - Abn, NCS	16	—
Left eye - week 52 - Abn, CS	41	—
Right eye - at screening visit - normal	212	—
Right eye - at screening visit - Abn, NCS	14	—
Right eye - at screening visit - Abn, CS	45	—
Right eye - week 52 - normal	217	—
Right eye - week 52 - Abn, NCS	14	—
Right eye - week 52 - Abn, CS	40	—
LiraglutideLeft eye - at screening visit - normal	211	—
Left eye - at screening visit - Abn, NCS	14	—
Left eye - at screening visit - Abn, CS	47	—
Left eye - week 52 - normal	212	—
Left eye - week 52 - Abn, NCS	15	—
Left eye - week 52 - Abn, CS	45	—
Right eye - at screening visit - normal	207	—
Right eye - at screening visit - Abn, NCS	12	—
Right eye - at screening visit - Abn, CS	54	—
Right eye - week 52 - normal	209	—
Right eye - week 52 - Abn, NCS	15	—
Right eye - week 52 - Abn, CS	49	—

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Fasting Glucagon as a Ratio to Baseline at 52 Weeks

Time frame:After 52 weeks of treatment

ratio, improvement

Publications (2)

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

Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: A subgroup analysis of two phase III trials.
Journal of diabetes investigation2021 Sep (month)PMID33595901doi:10.1111/jdi.13525via CT.gov reference
Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naïve Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial.
Diabetes, obesity & metabolism2019 Dec (month)PMID31407845doi:10.1111/dom.13856via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.