Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
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 given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

Detailed description:

Arms:
arm 1: 52 weeks treatment arm 2: First 12 weeks of treatment arm 3: Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)

Interventions: intervention 1: Glimepiride intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: Linagliptin
Intervention descriptions: intervention 1: 1-4 mg daily after 12 weeks intervention 2: Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily intervention 3: Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment intervention 4: Placebo mach to 5 mg linagliptin once daily after 12 weeks intervention 5: 5 mg once daily

Protocol document: