Study S001965

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

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

Registration

Registration: NCT02607306
Acronym: DUAL™ I Japan
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 819
Start: 2015-11-18
Primary completion: 2017-12-15
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:insulin degludec/liraglutide; DRUG:insulin degludec; DRUG:liraglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1170-1332; OTHER:JapicCTI-153089

Registered primary outcomes

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira [Week 0, Week 52]

Linked records (2)

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
R0014857	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. Kaku K, Diabetes, obesity & metabolism	2019	Randomized trial	PMID 31407845 DOI	cites ClinicalTrials.gov:NCT02607306; registry reference RESULT:31407845