drugset / Trial / NCT01557504
A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess: 1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years 2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets (excluding marking) 3. the pharmacokinetics of sitagliptin and metformin following the administration of two sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged 10 to 17 years.
Timeline
- Start
- 2012-07-18
- Primary completion
- 2014-04-29
- Completion
- 2014-04-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 2000 mg | — |
| Subject | Sitagliptin | Small molecule | 100 mg | — |
| Background | Levothyroxine | Other / unclassified | — | — |