CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,035 enrolled
Drug / intervention
sitagliptin +2 moredrug
Likely dose
sitagliptin 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/NCT00701090
NCT00701090Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Merck Sharp & Dohme LLC·interventional·Posted Jun 19, 2008·Updated Mar 10, 2017

In Brief

A Phase 3 clinical trial evaluating sitagliptin, Comparator: glimepiride, and 1 other intervention for Type 2 Diabetes Mellitus, Non Insulin Dependent and Diabetes Mellitus, Non-Insulin-Dependent. Completed, enrolled 1,035 participants.

Detailed Summary

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2008
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.0 years ago

Interventions

sitagliptindrug

Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks

Comparator: glimepiridedrug

glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.

open-label metformindrug

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.