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A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)

Clinical Trial Summary

The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy (alone or in combination with insulin). The primary hypothesis is that the addition of sitagliptin reduces A1C more than the addition of placebo after 20 weeks of treatment. Participants who complete the 20-week base period of the study may choose to participate in the extension period of the study and continue on or off treatment assigned during the base period for an additional 34 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01472367
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date December 7, 2011
Completion date September 17, 2019
View Details
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