drugset / Trial / NCT01342484
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2011-04
- Primary completion
- 2016-02
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linagliptin | Small molecule | 1 mg | Oral |
| Subject | Linagliptin | Small molecule | 5 mg | Oral |