Study S000361

A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01572740
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 257
Start: 2012-04-05
Primary completion: 2012-11-01
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:liraglutide; DRUG:placebo; DRUG:insulin
Results posted: TRUE
Secondary identifiers: OTHER:U1111-1122-4320; OTHER:JapicCTI-121802

Registered primary outcomes

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16 [Week 0, Week 16]

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
R0025067	Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial. Kaneko S, Journal of diabetes investigation	2018	Randomized trial	PMID 29277968 DOI	registry reference RESULT:29277968
R0026074	Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial. Seino Y, Journal of diabetes investigation	2016	Randomized trial	PMID 27182042 DOI	registry reference RESULT:27182042