CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,452 enrolled
Drug / intervention
Glimepiride +2 moredrug
Likely dose
Glimepiride 1mgfrom 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/NCT00968812
NCT00968812Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy

Janssen Research & Development, LLC·interventional·Posted Aug 31, 2009·Updated Jan 30, 2017

In Brief

A Phase 3 clinical trial evaluating Glimepiride, Canagliflozin (JNJ-28431754), and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 1,452 participants across 138 sites in 20 countries.

Detailed Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Bulgaria, Canada, Costa Rica, Denmark, Finland, Germany, India, Israel, Mexico, Norway, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.8 years ago

Interventions

Glimepiridedrug

Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.

Canagliflozin (JNJ-28431754)drug

Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.

Metformindrug

Metformin will be given orally at the protocol-specified dose for 104 weeks.