Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 227
Healthy volunteers: no

Brief summary:
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Detailed description:

Arms:
arm 1: 52 week treatment arm 2: First 18 weeks of treatment arm 3: Placebo patients switch to glimepiride week19-52

Interventions: intervention 1: Linagliptin intervention 2: Linagliptin Placebo intervention 3: Glimepiride
Intervention descriptions: intervention 1: 5mg once daily intervention 2: 0 mg placebo comparator for part 1 of study (to 18 weeks) intervention 3: 1-4mg for part 2 of study (weeks 19-52)

Protocol document: