Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 333
Healthy volunteers: no

Brief summary:
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

Detailed description:

Arms:
arm 1: Patients receive Linagliptin low dose tablets once daily arm 2: Patients receive Linagliptin medium dose tablets once daily arm 3: Patients receive Linagliptin high dose tablets once daily arm 4: Patients receive tablets identical to those containing Linagliptin low, medium and high dose arm 5: Patients receive Glimepiride tablets once daily

Interventions: intervention 1: Linagliptin intervention 2: Linagliptin intervention 3: Linagliptin intervention 4: Placebo intervention 5: Glimepiride
Intervention descriptions: intervention 1: Linagliptin medium dose tablet once daily intervention 2: Linagliptin high dose tablet once daily intervention 3: Linagliptin low dose tablet once daily intervention 4: Placebo tablets once daily intervention 5: Glimepiride tablets once daily

Protocol document: