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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Rivoglitazone HCl
Drug: rivoglitazone HCl
Drug: pioglitazone HCl
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
Drug: Rivoglitazone HCl
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
Experimental: 2
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
Drug: rivoglitazone HCl
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
Experimental: 3
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
Drug: rivoglitazone HCl
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
Active Comparator: 4
30 mg pioglitazone HCl capsules once daily for 12 weeks
Drug: pioglitazone HCl
30 mg capsules once daily for 12 weeks
Placebo Comparator: 5
Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules
Drug: placebo
matching tablets or capsule once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575874

Locations
China
Hong Kong, China
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
  More Information

No publications provided

Responsible Party: Dr. Alice Pik Shan Kong, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00575874     History of Changes
Other Study ID Numbers: CS011-A-J205
Study First Received: December 14, 2007
Last Updated: February 6, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare
Hong Kong: Department of Health

Keywords provided by Daiichi Sankyo Inc.:
rivoglitazone HCl
pioglitazone HCl
thiazolidinedione
peroxisome proliferator-activated receptor gamma (PPAR gamma)
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014