Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 561
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

Detailed description:

Arms:
arm 1: patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356 arm 2: patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose arm 3: patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose arm 4: patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose

Interventions: intervention 1: BI 1356 intervention 2: BI 1356 intervention 3: voglibose placebo intervention 4: BI 1356 placebo intervention 5: voglibose
Intervention descriptions: intervention 1: 5 mg/daily intervention 2: 10 mg/daily intervention 3: three times daily intervention 4: once daily intervention 5: 0.6 mg/daily

Protocol document: