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)

NCT01557504

Phase 1 Completed 25 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 2000 mg
Subject Sitagliptin Small molecule 100 mg
Background Levothyroxine Other / unclassified