CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 451 enrolled
Drug / intervention
Canagliflozin (JNJ-28431754) +2 moredrug
Likely dose
Canagliflozin (JNJ-28431754) 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/NCT00642278
NCT00642278Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Mar 25, 2008·Updated Jul 19, 2013

In Brief

A Phase 2 clinical trial evaluating Canagliflozin (JNJ-28431754), Sitagliptin, and 1 other intervention for Diabetes Mellitus, Type II and Diabetes Mellitus, Non Insulin Dependent. Completed, enrolled 451 participants across 78 sites in 13 countries.

Detailed Summary

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type II, Diabetes Mellitus, Non Insulin Dependent
CountriesArgentina, Bulgaria, Canada, Czechia, India, Malaysia, Mexico, Poland, Puerto Rico, Romania, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2008
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.3 years ago

Interventions

Canagliflozin (JNJ-28431754)drug

One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.

Sitagliptindrug

One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

Placebodrug

One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.