Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 567
Healthy volunteers: no

Brief summary:
A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Detailed description:

Arms:
arm 1: Linagliptin low dose + metformin 500 mg, bid arm 2: Linagliptin low dose + metformin 1000 mg bid arm 3: Metformin 1000 mg bid

Interventions: intervention 1: Linagliptin + metformin intervention 2: Linagliptin+metformin intervention 3: Metformin
Intervention descriptions: intervention 1: Linagliptin tablet low dose + metformin tablet 500 mg bid intervention 2: Linagliptin low dose tablet + metformin 1000 mg tablet bid intervention 3: Metformin 1000 mg tablet bid

Protocol document: