CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 426 enrolled
Drug / intervention
Sitagliptin +3 moredrug
Likely dose
Sitagliptin 25 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/NCT00509262
NCT00509262Phase 3Completed

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control

Merck Sharp & Dohme LLC·interventional·Posted Jul 31, 2007·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating Sitagliptin, Glipizide, and 2 other interventions for Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic. Completed, enrolled 426 participants.

Detailed Summary

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 31, 2007
Enrollment StartOct 9, 2007
Primary CompletionMar 16, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.9 years ago

Interventions

Sitagliptindrug

Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily

Glipizidedrug

Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)

Placebo for Sitagliptindrug

Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily

Placebo for Glipizidedrug

Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily