Last updated on October 2017

Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)


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) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment.

Detailed Study Description

This trial is of approximately 56 weeks in duration, including a screening period of up to 1 week, a 1-week single-blind placebo run-in period, a 20-week placebo-controlled, double blind treatment period [Phase A] and a 34-week double-blind active controlled treatment period [Phase B] during which participants randomized to the placebo arm who have not initiated glycemic rescue therapy with metformin during Phase A will receive metformin (in a blinded manner). A telephone contact will be performed 14 days after the last dose of study medication to assess for any serious adverse events (SAEs). Two arms of the study were removed from the study by a protocol amendment.

Clinical Study Identifier: NCT01485614

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Merck Sharp & Dohme (Argentina) Inc.
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MSD Brasil
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Merck Sharp & Dohme Bulgaria EOOD
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Merck Sharp & Dohme (I.A.) Corp.
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MDS Colombia SAS
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Merck Sharp & Dohme
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Merck Sharp & Dohme
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Merck Sharp & Dohme IDEA, Inc.
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MSD Sharp & Dohme GmbH
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Vianex, S.A. / MSD
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MSD CARD
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MSD Pharma Hungary Kft.
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Merck Sharp & Dohme Co. Ltd.
Hod Hasharon, Israel
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MSD Italia S.r.l.
Rome, Italy
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Merck Sharp & Dohme Latvija SIA
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UAB "Merck Sharp & Dohme"
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Merck Sharp & Dohme Ilaclari Ltd. Sti
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Merck Sharp & Dohme (I.A.) Corporation
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MSD Polska Sp. Z o.o.
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Merck Sharp & Dohme IDEA, Inc.
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Merck Sharp & Dohme
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Merck Sharp & Dohme
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