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

Type 2 Diabetes Clinical Trial

— RAISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575874
• Other study ID #: CS011-A-J205
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2007
• Last updated: February 6, 2009
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareHong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes

• HbA1c >6.5% and <10.0%

• FPG >126 mg/dL (7 mmol/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

• Imparied hepatic function

• NYHA Class II-IV cardiac status or hospitalization for CHF or EF<40%

• uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Rivoglitazone HCl
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
• rivoglitazone HCl
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
• rivoglitazone HCl
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
• pioglitazone HCl
30 mg capsules once daily for 12 weeks
• placebo
matching tablets or capsule once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo		12 weeks	No
Secondary	Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl		12 weeks	No