CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 272 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/NCT01064414
NCT01064414Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Janssen Research & Development, LLC·interventional·Posted Feb 8, 2010·Updated Aug 14, 2013

In Brief

A Phase 3 clinical trial evaluating Canagliflozin and Placebo for Diabetes Mellitus, Type 2 and Renal Insufficiency. Completed, enrolled 272 participants across 106 sites in 18 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Renal Insufficiency
CountriesAustralia, Belgium, Brazil, Canada, France, Germany, India, Latvia, Malaysia, Mexico, New Zealand, Poland, Romania, Russia, South Africa, South Korea, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.4 years ago

Interventions

Canagliflozindrug

One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information

Placebodrug

One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information