CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 678 enrolled
Drug / intervention
Canagliflozin +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/NCT01081834
NCT01081834Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Janssen Research & Development, LLC·interventional·Posted Mar 5, 2010·Updated Feb 23, 2017

In Brief

A Phase 3 clinical trial evaluating Canagliflozin, Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 678 participants across 78 sites in 18 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustria, Colombia, Estonia, Guatemala, Iceland, India, Lithuania, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, South Africa, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.3 years ago

Interventions

Canagliflozindrug

One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)

Placebodrug

One matching placebo capsule orally once daily for 26 weeks (Main Study)

Sitagliptindrug

One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)