CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
sitagliptin phosphate +3 moredrug
Likely dose
sitagliptin phosphate 100 mgfrom 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/NCT00830076
NCT00830076Phase 1Completed
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A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations

Merck Sharp & Dohme LLC·interventional·Posted Jan 27, 2009·Updated May 15, 2017

In Brief

A Phase 1 clinical trial evaluating sitagliptin phosphate, metformin hydrochloride, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 18 participants.

Detailed Summary

This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.

Study Details

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

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2009
Enrollment StartDec 2, 2008
Primary CompletionApr 30, 2009
Study CompletionMay 14, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.4 years ago

Interventions

sitagliptin phosphatedrug

Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.

metformin hydrochloridedrug

Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods.

Comparator: placebo sitagliptindrug

Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.

Comparator: placebo metformindrug

Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.