Clinical trial NCT00800176
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Start date: 2009-01-22; Completion date: 2009-10-28
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is \<=3 months

Detailed description:

Arms: arm 1: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.

During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. arm 2: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452. arm 3: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452. arm 4: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452. arm 5: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452. arm 6: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
Interventions: intervention 1: Placebo intervention 2: RO4998452 intervention 3: RO4998452 intervention 4: RO4998452 intervention 5: RO4998452 intervention 6: RO4998452
Intervention descriptions: intervention 1: po daily for 12 weeks intervention 2: 2.5mg po daily for 12 weeks intervention 3: 5mg po daily for 12 weeks intervention 4: 10mg po daily for 12 weeks intervention 5: 20mg po daily for 12 weeks intervention 6: 40mg po daily for 12 weeks

Protocol documents: