Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

Detailed description:

Arms:
arm 1: linagliptin low dose for children once daily arm 2: linagliptin high dose for children once daily arm 3: matching placebo for each linagliptin dose once daily

Interventions: intervention 1: placebo intervention 2: BI1356 low dose intervention 3: BI1356 high dose
Intervention descriptions: intervention 1: comparison of different dosages of drug (low vs high) vs placebo intervention 2: comparison of different dosages of drug (low vs high) vs placebo intervention 3: comparison of different dosages of drug (low vs high) vs placebo

Protocol document: