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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014