Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1058
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets

Interventions: intervention 1: linagliptin intervention 2: placebo
Intervention descriptions: intervention 1: active intervention 2: placebo to linagliptin 5 mg

Protocol document: