At a glance
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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
In Brief
A Phase 3 clinical trial evaluating liraglutide, placebo, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 257 participants across 23 sites.
Detailed Summary
This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.
Study Details
Timeline
Interventions
Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.