CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,912 enrolled
Drug / intervention
Pioglitazone +3 moredrug
Likely dose
Pioglitazone 45 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/NCT00484198
NCT00484198Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

Daiichi Sankyo·interventional·Posted Jun 8, 2007·Updated Jul 27, 2021

In Brief

A Phase 3 clinical trial evaluating Pioglitazone, Placebo, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 1,912 participants across 183 sites in 18 countries.

Detailed Summary

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Austria, Chile, Czechia, Germany, Hungary, India, Latvia, Mexico, Peru, Puerto Rico, Romania, Serbia, Slovakia, South Africa, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2007
Enrollment StartApr 23, 2007
Primary CompletionFeb 12, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.1 years ago

Interventions

Pioglitazonedrug

45 mg over-encapsulated tablet administered orally, once daily

Placebodrug

Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule

Rivoglitazonedrug

1.0 mg tablet administered orally, once daily

Rivoglitazonedrug

1.5 mg tablet administered orally, once daily