Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 257
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: insulin
Intervention descriptions: intervention 1: Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy. intervention 2: Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy. intervention 3: 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.

Protocol document: