Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 316
Healthy volunteers: no

Brief summary:
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

Detailed description:

Arms:
arm 1: patients receive linagliptin tablet once daily arm 2: patients receive linagliptin tablet once daily and metformin tablets twice daily

Interventions: intervention 1: metformin intervention 2: linagliptin intervention 3: metformin placebo intervention 4: metformin placebo
Intervention descriptions: intervention 1: 1000 mg to 2000 mg per day intervention 2: 5 mg daily intervention 3: 0 to 2 tablets daily intervention 4: 4 tablets daily

Protocol document: