CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 218 enrolled
Drug / intervention
Canagliflozin, 100 mg +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/NCT02025907
NCT02025907Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

Janssen Research & Development, LLC·interventional·Posted Jan 1, 2014·Updated Oct 31, 2016

In Brief

A Phase 4 clinical trial evaluating Canagliflozin, 100 mg, Canagliflozin, 300 mg, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 218 participants across 57 sites in 5 countries.

Detailed Summary

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Canada, France, Germany, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 1, 2014
Enrollment StartFeb 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.5 years ago

Interventions

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.

Placebodrug

One placebo capsule taken orally (by mouth) once daily.