CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,401 enrolled
Drug / intervention
Canagliflozin +1 moredrug
Likely dose
Canagliflozin 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/NCT02065791
NCT02065791Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

Janssen Research & Development, LLC·interventional·Posted Feb 19, 2014·Updated Dec 5, 2019

In Brief

A Phase 3 clinical trial evaluating Canagliflozin and Placebo for Diabetes Mellitus, Type 2 and Diabetic Nephropathy. Completed, enrolled 4,401 participants across 575 sites in 34 countries.

Detailed Summary

The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Diabetic Nephropathy
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Guatemala, Hungary, India, Japan, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Arab Emirates, United Kingdom, United States
CollaboratorsThe George Institute for Global Health, Australia

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2014
Enrollment StartFeb 17, 2014
Primary CompletionOct 30, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.4 years ago

Interventions

Canagliflozindrug

One 100 mg over-encapsulated tablet orally once daily

Placebodrug

One matching placebo capsule orally (by mouth) once daily