Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 857
Healthy volunteers: no

Brief summary:
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Detailed description:

Arms:
arm 1: BI 1356 low dose + metformin 500 mg, twice daily arm 2: matching placebo arm 3: BI 1356 low dose + metformin 1000 mg, twice daily arm 4: Metformin 500 mg, twice daily arm 5: Metformin 1000 mg, twice daily arm 6: BI 1356 high dose, once daily

Interventions: intervention 1: BI 1356 intervention 2: BI 1356 + metformin intervention 3: Bi 1356 + metformin intervention 4: Metformin intervention 5: metformin intervention 6: matching placebo
Intervention descriptions: intervention 1: BI 1356 high dose tablet, once daily intervention 2: BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily intervention 3: BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily intervention 4: Metformin 500 mg tablet, twice daily intervention 5: metformin 1000 mg tablet, twice daily intervention 6: matching placebo

Protocol document: