Study S002038

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

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02911948
Acronym: DUAL™ II Japan
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 210
Start: 2016-09-21
Primary completion: 2017-11-17
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:Insulin degludec/liraglutide; DRUG:Insulin degludec
Results posted: TRUE
Secondary identifiers: OTHER:U1111-1178-3453; OTHER:JapicCTI-163385

Registered primary outcomes

Change in Glycosylated Haemoglobin (HbA1c) [week 0, week 26]

Linked records (4)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0013892	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, Journal of diabetes investigation	2021	Randomized trial	PMID 33595901 DOI	registry reference RESULT:33595901
R0022345	IDegLira Improves Glycemic Control in Japanese Patients with Uncontrolled Type 2 Diabetes on Premixed Insulin Therapy. Watada H, Diabetes therapy : research, treatment and education of diabetes and related disorders	2020	Randomized trial	PMID 31760599 DOI	cites ClinicalTrials.gov:NCT02911948; registry reference DERIVED:31760599
R0015589	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, Diabetes, obesity & metabolism	2019	Randomized trial	PMID 31423685 DOI	registry reference RESULT:31423685
R0051874	148-OR: IDegLira Improves Glycemic Control in Japanese Patients with Type 2 Diabetes (T2D) Uncontrolled on Premixed Insulin Therapy Hirotaka Watada, Diabetes	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02911948