Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1560
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Detailed description:

Arms:
arm 1: patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride arm 2: patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)

Interventions: intervention 1: Placebo identical to BI 1356 5mg intervention 2: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg intervention 3: BI 1356 intervention 4: Glimepiride
Intervention descriptions: intervention 1: Placebo tablet once daily intervention 2: Placebo tablets once daily intervention 3: 5mg, once daily in the morning for 104 weeks intervention 4: 1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Protocol document: