- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575874
Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes (RAISE)
February 6, 2009 updated by: Daiichi Sankyo Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
|
0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
|
Experimental: 2
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
|
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
|
Experimental: 3
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
|
1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
|
Active Comparator: 4
30 mg pioglitazone HCl capsules once daily for 12 weeks
|
30 mg capsules once daily for 12 weeks
|
Placebo Comparator: 5
Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules
|
matching tablets or capsule once daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 18, 2007
Study Record Updates
Last Update Posted (Estimate)
February 9, 2009
Last Update Submitted That Met QC Criteria
February 6, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS011-A-J205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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