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

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ClinicalTrials.gov Identifier: NCT00575874
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Rivoglitazone HCl Drug: rivoglitazone HCl Drug: pioglitazone HCl Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Primary Completion Date : June 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575874


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

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
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009

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