CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 279 enrolled
Drug / intervention
Canagliflozin 50 mg +3 moredrug
Likely dose
Canagliflozin 50 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/NCT01340664
NCT01340664Phase 2Completed

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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

Janssen Research & Development, LLC·interventional·Posted Apr 22, 2011·Updated Sep 16, 2014

In Brief

A Phase 2 clinical trial evaluating Canagliflozin 50 mg, Placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 279 participants across 61 sites in 7 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 are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Mexico, Romania, Russia, Slovakia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2011
Enrollment StartJul 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.2 years ago

Interventions

Canagliflozin 50 mgdrug

One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks

Placebodrug

1 placebo capsule taken orally twice daily with a meal for 18 weeks

Canagliflozin 150 mgdrug

1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks

Metformindrug

The patient's stable daily dose of Metformin background therapy should be continued throughout the study.