Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Detailed description:

Arms:
arm 1: Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin. arm 2: Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin. arm 3: Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.

Interventions: intervention 1: Placebo (linagliptin) intervention 2: Placebo (linagliptin) intervention 3: Sitagliptin intervention 4: Placebo (sitagliptin) intervention 5: Placebo (sitagliptin) intervention 6: Linagliptin
Intervention descriptions: intervention 1: once daily for 28 days intervention 2: once daily for 28 days intervention 3: 100 mg once daily for 28 days intervention 4: once daily for 28 days intervention 5: once daily for 28 days intervention 6: 5mg once daily for 28 days

Protocol document: