CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5,813 enrolled
Drug / intervention
Placebo +2 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/NCT01989754
NCT01989754Phase 4Completed
CompareCT.gov

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus

Janssen Research & Development, LLC·interventional·Posted Nov 21, 2013·Updated Dec 11, 2018

In Brief

A Phase 4 clinical trial evaluating Placebo, Canagliflozin, 100 mg, and 1 other intervention for Diabetes Mellitus, Type 2 and Albuminuria. Completed, enrolled 5,813 participants across 342 sites in 25 countries.

Detailed Summary

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Albuminuria
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hungary, Italy, Malaysia, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsThe George Institute for Global Health, Australia

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 21, 2013
Enrollment StartJan 16, 2014
Primary CompletionFeb 23, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.6 years ago

Interventions

Placebodrug

One placebo capsule taken orally (by mouth) once daily for 156 weeks

Canagliflozin, 100 mgdrug

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

Canagliflozin, 300 mgdrug

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