NCT02911948 (DUAL™ II Japan) is a Phase 3 clinical trial of Insulin degludec/liraglutide in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT02911948?

NCT02911948 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT02911948?

Interventions in NCT02911948: Insulin degludec/liraglutide, Insulin degludec.

What condition does NCT02911948 study?

NCT02911948 studies Diabetes, Diabetes Mellitus, Type 2.

Is NCT02911948 still recruiting?

NCT02911948 is currently completed. Last updated 9 April 2021.

Are results published for NCT02911948?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-04-09 · How we verify

NCT02911948: DUAL™ II Japan

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

Completed Phase 3 Results posted Last updated 9 April 2021

What this trial tests

Phase 3 trial testing Insulin degludec/liraglutide in Diabetes in 210 participants. Completed in 22 November 2017.

Timeline

21 September 2016

Primary endpoint
17 November 2017

22 November 2017

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	210
Start date	21 September 2016
Primary completion	17 November 2017
Estimated completion	22 November 2017
Sites	38 locations across Japan

Drugs / interventions tested

Insulin degludec/liraglutide
Insulin degludec (INSULIN DEGLUDEC) — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

20 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Glycosylated Haemoglobin (HbA1c) Primary · week 0, week 26

Change from baseline (week 0) in HbA1c after 26 weeks of treatment.

Group	Value	95% CI
Insulin Degludec/Liraglutide	-1.95	± 1.01
Insulin Degludec	-0.65	± 0.98

Change in Body Weight Secondary · week 0, week 26

Change from baseline (week 0) in body weight after 26 weeks of treatment.

Group	Value	95% CI
Insulin Degludec/Liraglutide	-0.7	± 3.5
Insulin Degludec	0.7	± 2.7

Change in Fasting Plasma Glucose (FPG) Secondary · week 0, week 26

Change from baseline (week 0) in FPG after 26 weeks of treatment.

Group	Value	95% CI
Insulin Degludec/Liraglutide	-2.81	± 3.17
Insulin Degludec	-2.29	± 2.68

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes Secondary · During 26 weeks of treatment

Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \< 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to activel

Group	Value	95% CI
Insulin Degludec/Liraglutide	124
Insulin Degludec	109

Daily Insulin Dose Secondary · After 26 weeks

Actual daily total insulin dose after 26 weeks.

Group	Value	95% CI
Insulin Degludec/Liraglutide	37.6	± 11.4
Insulin Degludec	41.2	± 11.5

Responder (Yes/no): HbA1c Less Than 7.0% Secondary · After 26 weeks

Number of subjects with HbA1c less than 7.0% after 26 weeks.

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	75
Insulin Degludec	23

Group	Value	95% CI
Insulin Degludec/Liraglutide	30
Insulin Degludec	82

Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain Secondary · After 26 weeks

Number of subjects with HbA1c less than 7.0% and without weight gain after 26 weeks.

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	50
Insulin Degludec	9

Group	Value	95% CI
Insulin Degludec/Liraglutide	55
Insulin Degludec	96

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 Secondary · After 26 weeks

Number of subjects with HbA1c less than 7.0% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \< 3.1 mmol/L (

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	70
Insulin Degludec	20

Group	Value	95% CI
Insulin Degludec/Liraglutide	35
Insulin Degludec	81

Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Secondary · After 26 weeks

Number of subjects with HbA1c less than 7.0% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose va

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	49
Insulin Degludec	7

Group	Value	95% CI
Insulin Degludec/Liraglutide	56
Insulin Degludec	94

Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Secondary · After 26 weeks

Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks.

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	57
Insulin Degludec	9

Group	Value	95% CI
Insulin Degludec/Liraglutide	48
Insulin Degludec	96

Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain Secondary · After 26 weeks

Number of subjects with HbA1c less than or equal to 6.5% and without weight gain

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	38
Insulin Degludec	4

Group	Value	95% CI
Insulin Degludec/Liraglutide	67
Insulin Degludec	101

Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Secondary · After 26 weeks

Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value \<

Yes

Group	Value	95% CI
Insulin Degludec/Liraglutide	53
Insulin Degludec	8

Group	Value	95% CI
Insulin Degludec/Liraglutide	52
Insulin Degludec	93

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 (randomisation) to week 26 (end of treatment) and 7 days after end of treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Insulin Degludec/Liraglutide

Serious: 3/105 (3%)

Deaths: 0/105

Insulin Degludec

Serious: 4/105 (4%)

Deaths: 0/105

Serious adverse events (9 terms)

Reaction	System	Insulin Degludec/Liraglutide	Insulin Degludec
Acute myocardial infarction	Cardiac disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—
Loss of consciousness	Nervous system disorders	—	—
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Retinal detachment	Eye disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Insulin Degludec/Liraglutide	Insulin Degludec
Viral upper respiratory tract infection	Infections and infestations	—	—
Diabetic retinopathy	Eye disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Acute myocardial infarction, Cardiac failure congestive, Cholecystitis acute, Gastroenteritis, Hip fracture, Loss of consciousness, Pancreatic carcinoma, Renal cell carcinoma.

Data from ClinicalTrials.gov NCT02911948 adverse events section.

Sponsor's own description

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with a maximum dose of 50 units of insulin degludec in Japanese individuals with type 2 diabetes in a phase 3, double-blind, randomized trial.
Watada H, Kaneko S, Komatsu M, Agner BR, et al · · 2019 · cited 25× · PMID 31423685 · DOI 10.1111/dom.13859
IDegLira Improves Glycemic Control in Japanese Patients with Uncontrolled Type 2 Diabetes on Premixed Insulin Therapy.
Watada H, Ross Agner BF, Doshi A, Bardtrum L, et al · · 2020 · cited 11× · PMID 31760599 · DOI 10.1007/s13300-019-00730-y
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.
Komatsu M, Watada H, Kaneko S, Ross Agner BF, et al · · 2021 · cited 9× · PMID 33595901 · DOI 10.1111/jdi.13525
Insulin degludec/liraglutide versus its monotherapy on T2D patients: A lifetime cost-utility analysis in China.
Han G, Hu S, Zhang X, Qiu Z, et al · · 2022 · cited 3× · PMID 36467033 · DOI 10.3389/fphar.2022.1011624

Verify or expand the search:

Other trials of Insulin degludec/liraglutide

Trials testing the same drug.

NCT03823339 — A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Ara · completed
NCT03175120 — A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects Wi · Phase 3 · completed
NCT03172494 — A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabet · Phase 3 · completed

Other recruiting trials for Diabetes

Currently open trials in the same condition.

NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells · NA · recruiting
NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02911948 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 9 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02911948.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing