CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Sitagliptin phosphate +1 moredrug
Likely dose
Sitagliptin phosphate 240 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00730275
NCT00730275Phase 1Completed
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A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents

Merck Sharp & Dohme LLC·interventional·Posted Aug 8, 2008·Updated May 12, 2017

In Brief

A Phase 1 clinical trial evaluating Sitagliptin phosphate and Comparator: matching placebo for Type 2 Diabetes. Completed, enrolled 35 participants.

Detailed Summary

This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2008
Enrollment StartJul 18, 2008
Primary CompletionDec 30, 2010
Study CompletionFeb 14, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.9 years ago

Interventions

Sitagliptin phosphatedrug

Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.

Comparator: matching placebodrug

Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.