Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 389
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms:
arm 1: BI 1356 5mg in initial combination therapy with pioglitazone 30 mg arm 2: Placebo in initial combination therapy with pioglitazone 30 mg

Interventions: intervention 1: placebo + pioglitazone (30 mg) intervention 2: Linagliptin + pioglitazone (30 mg)
Intervention descriptions: intervention 1: placebo + overcapsulated 30 mg tablet, once daily intervention 2: 5 mg tablet + overcapsulated 30 mg tablet, once daily

Protocol document: