CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 756 enrolled
Drug / intervention
Sitagliptin 100 mg +3 moredrug
Likely dose
Sitagliptin 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/NCT01137812
NCT01137812Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

Janssen Research & Development, LLC·interventional·Posted Jun 4, 2010·Updated Jan 15, 2015

In Brief

A Phase 3 clinical trial evaluating Sitagliptin 100 mg, Canagliflozin 300 mg, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 756 participants across 184 sites in 17 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustria, Belgium, Brazil, Canada, Denmark, France, Germany, India, Israel, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartJul 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.1 years ago

Interventions

Sitagliptin 100 mgdrug

One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

Canagliflozin 300 mgdrug

One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

Metformindrug

Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.

Sulphonylureadrug

Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.