NCT00484198

Study of Rivoglitazone in Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,912 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Pioglitazone	45 mg over-encapsulated tablet administered orally, once daily
DRUG	Placebo	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
DRUG	Rivoglitazone	1.0 mg tablet administered orally, once daily
DRUG	Rivoglitazone	1.5 mg tablet administered orally, once daily

Timeline

• Start date: 2007-04-23
• Primary completion: 2009-02-12
• Completion: 2009-02-12
• First posted: 2007-06-08
• Last updated: 2021-07-27
• Results posted: 2021-07-27

Locations

183 sites across 18 countries: United States, Argentina, Austria, Chile, Czechia, Germany, Hungary, India, Latvia, Mexico, Peru, Puerto Rico, Romania, Serbia, Slovakia, South Africa, Ukraine, United Kingdom