Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
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
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Linagliptin 1 mg; p = 0.3295; Mean Difference (Net) -0.48 (95% CI -1.47 to 0.51); Mixed Models Analysis NCT01342484 ↗
registry analysis (superiority or other test); Placebo vs Linagliptin 5 mg; p = 0.1447; Mean Difference (Net) -0.63 (95% CI -1.50 to 0.23); Mixed Models Analysis NCT01342484 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linagliptin | Unknown | 1 mg | Oral |
| Subject | Linagliptin | Unknown | 5 mg | Oral |