Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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