CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,330 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Canagliflozin (JNJ-28431754) 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/NCT01032629
NCT01032629Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

Janssen Research & Development, LLC·interventional·Posted Dec 15, 2009·Updated Dec 7, 2018

In Brief

A Phase 3 clinical trial evaluating Placebo, Canagliflozin (JNJ-28431754) 100 mg, and 1 other intervention for Diabetes Mellitus, Type 2 and 2 related conditions. Completed, enrolled 4,330 participants across 305 sites in 25 countries.

Detailed Summary

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors
CountriesArgentina, Australia, Belgium, Canada, Colombia, Czechia, Estonia, France, Germany, Hungary, India, Israel, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Ukraine, United Kingdom, United States
CollaboratorsThe George Institute for Global Health, Australia

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2009
Enrollment StartDec 9, 2009
Primary CompletionFeb 22, 2017
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 16.5 years ago

Interventions

Placebodrug

One placebo capsule taken orally (by mouth) once daily

Canagliflozin (JNJ-28431754) 100 mgdrug

One 100 mg capsule taken orally (by mouth) once daily

Canagliflozin (JNJ-28431754) 300 mgdrug

One 300 mg capsule taken orally (by mouth) once daily