Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
RAISE
A Randomized, Double-Blind, Placebo-Controlled, Dose and Active Comparator-Controlled Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 9, 2009
February 1, 2009
10 months
December 14, 2007
February 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo
12 weeks
Secondary Outcomes (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
12 weeks
Study Arms (5)
1
EXPERIMENTAL0.5 mg rivoglitazone HCl tablets once daily for 12 weeks
2
EXPERIMENTAL1.0 mg rivoglitazone HCl tablets once daily for 12 weeks
3
EXPERIMENTAL1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
4
ACTIVE COMPARATOR30 mg pioglitazone HCl capsules once daily for 12 weeks
5
PLACEBO COMPARATORMatching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- HbA1c \>6.5% and \<10.0%
- FPG \>126 mg/dL (7 mmol/L) and \< 270 mg/dL (15 mmol/L)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2008
Study Completion
January 1, 2009
Last Updated
February 9, 2009
Record last verified: 2009-02