Obese Patients With Type 2 Diabetes
RIO-Diabetes
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes
1 other identifier
interventional
1,045
11 countries
55
Brief Summary
To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Oct 2001
Typical duration for phase_3 obesity
55 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
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 23, 2002
CompletedFirst Posted
Study publicly available on registry
January 24, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedApril 20, 2009
April 1, 2009
2.6 years
January 23, 2002
April 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
Secondary Outcomes (1)
Metabolic parameters
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Sanofilead
Study Sites (55)
Innovative Clinical Trials
Birmingham, Alabama, 35209, United States
Lovelace Scientific Resources
Phoenix, Arizona, 85016, United States
Advanced Clinicla Therapeutics, LLC
Tucson, Arizona, 85712, United States
Southern California Prevention and Research Center Inc. (SPARC)
Encino, California, 91436, United States
Anderson Clinical Research
San Bernardino, California, 92408, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
North East Clinical Research
Hamden, Connecticut, 06518, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Jackson Downey, MD
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
DMI Helathcare Group
Largo, Florida, 33773, United States
Orlando Clinical Research Center
Orlando, Florida, 32806, United States
University Clinical Research
Pembroke Pines, Florida, 33024, United States
Comprehensive NeuroScience, Inc.
Sarasota, Florida, 34232, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
CSRA Partners in Health, Inc.
Augusta, Georgia, 30909, United States
nTouch Research
Marietta, Georgia, 30066, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Gulf States Clinical Trails, LLC
Kenner, Louisiana, 70062, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
Androscoggin Cardiology Associates
Auburn, Maine, United States
Phase III Clinical Research
Fall River, Massachusetts, 02720, United States
JM Clinical Trials, Inc.
Swansea, Massachusetts, 02777, United States
Twin Cities Clinical Research
Arden Hills, Minnesota, 55126, United States
Lovelace Scientific Resources
Las Vegas, Nevada, 89014, United States
Endocrinology and Diabetes Consultants, PC
Dover, New Hampshire, 03820, United States
Radiant Reseach-Moorestown
Moorestown, New Jersey, 08057, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Physician Clinical Research Service
White Plains, New York, 10605, United States
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28207, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
MFP Research, Inc.
Cincinnati, Ohio, 45242, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Radiant Research
Portland, Oregon, 97201, United States
Medical University of South Carolina, Division of Clinical Pharmacology
Charleston, South Carolina, 29425, United States
Costal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
TriCities Medical Reseach
Bristol, Tennessee, 37620, United States
Diabetes $ Glandular Disease Clinic, PA
San Antonio, Texas, 78229-4810, United States
Endocrine and Diabetes
Ogden, Utah, 84403, United States
National Clinical Research
Richmond, Virginia, 23294, United States
Salem Veterans Affairs Medical Center (151)
Salem, Virginia, 24153, United States
The Chase Wellness Center, Inc.
Virginia Beach, Virginia, 23455, United States
Sanofi-aventis Administrative Office
Buenos Aires, Argentina
Sanofi-aventis Administrative Office
Diegem, Belgium
Sanofi-aventis Administrative Office
Laval, Canada
Sanofi-aventis Administrative Office
Prague, Czechia
Sanofi-aventis Administrative Office
Helsinki, Finland
Sanofi-aventis Administrative Office
Paris, France
Sanofi-aventis Administrative Office
Berlin, Germany
Sanofi-aventis Administrative Office
Gouda, Netherlands
Sanofi-aventis Administrative office
Warsaw, Poland
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom
Related Publications (1)
Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72. doi: 10.1016/S0140-6736(06)69571-8.
PMID: 17098084RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2002
First Posted
January 24, 2002
Study Start
October 1, 2001
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
April 20, 2009
Record last verified: 2009-04