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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00575874
First received: December 14, 2007
Last updated: February 6, 2009
Last verified: February 2009

December 14, 2007
February 6, 2009
August 2007
June 2008   (final data collection date for primary outcome measure)
Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00575874 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • Experimental: 1
    0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
    Intervention: Drug: Rivoglitazone HCl
  • Experimental: 2
    1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
    Intervention: Drug: rivoglitazone HCl
  • Experimental: 3
    1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
    Intervention: Drug: rivoglitazone HCl
  • Active Comparator: 4
    30 mg pioglitazone HCl capsules once daily for 12 weeks
    Intervention: Drug: pioglitazone HCl
  • Placebo Comparator: 5
    Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
January 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00575874
CS011-A-J205
No
Dr. Alice Pik Shan Kong, The Chinese University of Hong Kong
Daiichi Sankyo Co., Ltd.
Not Provided
Not Provided
Daiichi Sankyo Inc.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP