Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 302
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

Detailed description:

Arms:
arm 1: Placebo tablets matching BI 1356 arm 2: BI 1356 dose 1 once daily arm 3: BI 1356 dose 2 once daily arm 4: BI 1356 dose 3 once daily arm 5: Metformin

Interventions: intervention 1: Placebo intervention 2: BI 1356 dose 3 once daily intervention 3: BI 1356 dose 2 once daily intervention 4: BI 1356 dose 1 once daily intervention 5: Metformin
Intervention descriptions: intervention 1: Placebo matching BI 1356 intervention 2: BI 1356 dose 3 once daily intervention 3: BI 1356 dose 2 once daily intervention 4: BI 1356 dose 1 once daily intervention 5: Metformin

Protocol document: