Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: rivoglitazone HCl; Drug: Placebo

• Registration Number: NCT00575471
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-27
• Last Update Posted: 2009-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• type 2 diabetes mellitus
• HbA1c >6.5% and <10%
• FPG >126 mg/dL (7mmol/L) and <270 mg/dL (15 mmol/L)

Exclusion Criteria

• history of type 1 diabetes
• history of ketoacidosis
• current insulin therapy
• C-peptide <0.5ng/mL
• impaired hepatic function
• CHF or history of CHF (NYHA stage I - IV)
• uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	rivoglitazone HCl	rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks
1	rivoglitazone HCl	rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks
2	rivoglitazone HCl	rivoglitazone HCl 1 mg tablets once daily for 12 weeks
4	Placebo	Matching placebo tablets once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline for rivoglitazone compared to placebo	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo	12 weeks