Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 689
Healthy volunteers: no

Brief summary:
The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: patients to receive linagliptin +metformin QD arm 2: patients to receive metformin BID

Interventions: intervention 1: metformin placebo intervention 2: linagliptin placebo intervention 3: metformin intervention 4: metformin intervention 5: linagliptin
Intervention descriptions: intervention 1: metformin placebo tablets 500mg intervention 2: linagliptin placebo tablets 5mg intervention 3: metformin tablets 500mg intervention 4: metformin tablets 500 mg intervention 5: linagliptin tablets 5mg

Protocol document: