Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes
A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes
1 other identifier
interventional
441
1 country
74
Brief Summary
This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Dec 2004
Shorter than P25 for phase_2 type-2-diabetes
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMay 10, 2021
May 1, 2021
1 year
September 1, 2005
May 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Secondary Outcomes (1)
FPG, Lipids, hsCRP, Adiponectin
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes in male or female patients
- Between 18 and 75 years of age
- With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization
You may not qualify if:
- Type 1 diabetics or type 2 diabetics currently on insulin therapy
- Patients unwilling or unable to discontinue their anti-diabetic medication(s)
- History of ketoacidosis
- History of therapy with rosiglitazone, troglitazone, pioglitazone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (74)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Columbiana, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Sherwood, Arkansas, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Moreno Valley, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Mateo, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Vista, California, United States
Unknown Facility
West Hills, California, United States
Unknown Facility
Newark, Delaware, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Cocoa Beach, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Warner Robins, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Gurnee, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Livonia, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Bozeman, Montana, United States
Unknown Facility
Butte, Montana, United States
Unknown Facility
Great Falls, Montana, United States
Unknown Facility
Voorhees Township, New Jersey, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Marion, Ohio, United States
Unknown Facility
Clinton, Oklahoma, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Simpsonville, South Carolina, United States
Unknown Facility
Bristol, Tennessee, United States
Unknown Facility
Carrollton, Texas, United States
Unknown Facility
Conroe, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Midland, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Spring, Texas, United States
Unknown Facility
Sugar Land, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Lakewood, Washington, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Renton, Washington, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Related Publications (1)
Truitt KE, Goldberg RB, Rosenstock J, Chou HS, Merante D, Triscari J, Wang AC. A 26-week, placebo- and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. Curr Med Res Opin. 2010 Jun;26(6):1321-31. doi: 10.1185/03007991003715079.
PMID: 20370378DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
December 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
May 10, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share