NCT00575874

Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Dose and Active Comparator-Controlled Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Rivoglitazone HCl	0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
DRUG	rivoglitazone HCl	1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
DRUG	rivoglitazone HCl	1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
DRUG	pioglitazone HCl	30 mg capsules once daily for 12 weeks
DRUG	placebo	matching tablets or capsule once daily for 12 weeks

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-06-01
• Completion: 2009-01-01
• First posted: 2007-12-18
• Last updated: 2009-02-09

Locations

1 site across 1 country: China