Last updated on May 2018

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


Brief description of study

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 Study Identifier: NCT01472367

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Anirban Roychowdhury

MSD Pharmaceuticals Pvt. Ltd
Colombo, Sri Lanka
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