CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 211 enrolled
Drug / intervention
Comparator: sitagliptin phosphate +3 moredrug
Likely dose
Comparator: 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/NCT00511108
NCT00511108Phase 1Completed
CompareCT.gov

A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

Merck Sharp & Dohme LLC·interventional·Posted Aug 3, 2007·Updated May 12, 2017

In Brief

A Phase 1 clinical trial evaluating Comparator: sitagliptin phosphate, Comparator: pioglitazone, and 2 other interventions for Type 2 Diabetes Mellitus (T2DM). Completed, enrolled 211 participants.

Detailed Summary

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus (T2DM)
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 3, 2007
Enrollment StartJul 11, 2007
Primary CompletionFeb 24, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.9 years ago

Interventions

Comparator: sitagliptin phosphatedrug

sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.

Comparator: pioglitazonedrug

pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Comparator: placebo to pioglitazonedrug

pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Comparator: placebo to sitagliptindrug

sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.