Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 701
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 patients with type 2 diabetes mellitus with insufficient glycaemic control

Detailed description:

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

Interventions: intervention 1: linagliptin intervention 2: linagliptin
Intervention descriptions: intervention 1: Patients receive linagliptin 5 mg tablets once daily intervention 2: Patients receive linagliptin 5 mg tablets once daily

Protocol document: