Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 746
Healthy volunteers: no

Brief summary:
This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Detailed description:

Arms:
arm 1: Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195). arm 2: Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195). arm 3: Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195). arm 4: Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

Interventions: intervention 1: liraglutide intervention 2: glimepiride intervention 3: liraglutide intervention 4: placebo intervention 5: placebo intervention 6: placebo
Intervention descriptions: intervention 1: 1.8 mg for s.c. (under the skin) injection intervention 2: 8 mg capsule intervention 3: 1.2 mg for s.c. (under the skin) injection intervention 4: Glimepiride placebo, 8mg capsule intervention 5: Liraglutide placebo, 200 mcl intervention 6: Liraglutide placebo, 300 mcl

Protocol document: