Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 491
Healthy volunteers: no

Brief summary:
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Detailed description:

Arms:
arm 1: linagliptin low dose twice daily arm 2: placebo matching linagliptin arm 3: linagliptin medium dose once daily

Interventions: intervention 1: linagliptin low dose intervention 2: placebo intervention 3: linagliptin medium dose
Intervention descriptions: intervention 1: patient to receive tablets containing low dose linagliptin twice daily intervention 2: patient to receive placebo tablet(s) matching linagliptin intervention 3: patient to receive a tablet containing medium dose linagliptin once daily

Protocol document: