Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1091
Healthy volunteers: no

Brief summary:
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Detailed description:

Arms:
arm 1: Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 2: Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 3: Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 4: Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo arm 5: Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo

Interventions: intervention 1: liraglutide intervention 2: metformin intervention 3: glimepiride intervention 4: placebo intervention 5: placebo intervention 6: liraglutide intervention 7: liraglutide
Intervention descriptions: intervention 1: 0.6 mg for s.c. (under the skin) injection. intervention 2: 1.5-2.0 g tablets intervention 3: 4 mg tablets intervention 4: Glimepiride placebo 1 mg and 2 mg tablets intervention 5: Liraglutide placebo 1-3 mL for s.c. (under the skin) injection intervention 6: 1.2 mg for s.c. (under the skin) injection intervention 7: 1.8 mg for s.c. (under the skin) injection

Protocol document: