Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 574
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

Detailed description:

Arms:
arm 1: biguanide plus linagliptin arm 2: glinide plus linagliptin arm 3: glitazone plus linagliptin arm 4: sulfonylurea plus linagliptin arm 5: alpha-glucosidase inhibitor plus linagliptin arm 6: sulfonylurea plus metformin arm 7: alpha-glucosidase inhibitor plus metformin

Interventions: intervention 1: Linagliptin intervention 2: Linagliptin intervention 3: Metformin intervention 4: Metformin intervention 5: Linagliptin intervention 6: Linagliptin intervention 7: Linagliptin
Intervention descriptions: intervention 1: Linagliptin once daily intervention 2: Linagliptin once daily intervention 3: Metformin twice or three time per day intervention 4: Metformin twice or three time per day intervention 5: Linagliptin once daily intervention 6: Linagliptin once daily intervention 7: Linagliptin once daily

Protocol document: