Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1263
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms:
arm 1: patient receives a tablet with intended final marketed dose arm 2: patient receives a tablet identical to those containing Linagliptin

Interventions: intervention 1: Placebo intervention 2: Linagliptin
Intervention descriptions: intervention 1: Placebo, identical to Linagliptin tablet intervention 2: intended final marketed dose

Protocol document: