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Obese Patients With Type 2 Diabetes (RIO-Diabetes)
This study has been completed.
First Received: January 23, 2002   Last Updated: April 17, 2009   History of Changes
Sponsor: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00029848
  Purpose

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


Condition Intervention Phase
Obesity
Diabetes Mellitus, Non-Insulin-Dependent
Obesity in Diabetes
Drug: Rimonabant (SR141716)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Change in body weight

Secondary Outcome Measures:
  • Metabolic parameters

Enrollment: 1045
Study Start Date: October 2001
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • BMI must be greater than 27 and less than 40
  • Treated Type 2 Diabetes on single therapy treatment for at least 1 year
  • Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029848

  Hide Study Locations
Locations
United States, Alabama
Innovative Clinical Trials
Birmingham, Alabama, United States, 35209
United States, Arizona
Advanced Clinicla Therapeutics, LLC
Tucson, Arizona, United States, 85712
Lovelace Scientific Resources
Phoenix, Arizona, United States, 85016
United States, California
Anderson Clinical Research
San Bernardino, California, United States, 92408
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Southern California Prevention and Research Center Inc. (SPARC)
Encino, California, United States, 91436
United States, Connecticut
North East Clinical Research
Hamden, Connecticut, United States, 06518
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Orlando Clinical Research Center
Orlando, Florida, United States, 32806
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
DMI Helathcare Group
Largo, Florida, United States, 33773
Comprehensive NeuroScience, Inc.
Sarasota, Florida, United States, 34232
Jackson Downey, MD
Jacksonville, Florida, United States, 32205
University Clinical Research
Pembroke Pines, Florida, United States, 33024
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32205
United States, Georgia
nTouch Research
Marietta, Georgia, United States, 30066
CSRA Partners in Health, Inc.
Augusta, Georgia, United States, 30909
United States, Indiana
Physicians Research Group
Indianapolis, Indiana, United States, 46250
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Medical Research Institute
Slidell, Louisiana, United States, 70458
Gulf States Clinical Trails, LLC
Kenner, Louisiana, United States, 70062
United States, Maine
Androscoggin Cardiology Associates
Auburn, Maine, United States
United States, Massachusetts
Phase III Clinical Research
Fall River, Massachusetts, United States, 02720
JM Clinical Trials, Inc.
Swansea, Massachusetts, United States, 02777
United States, Minnesota
Twin Cities Clinical Research
Arden Hills, Minnesota, United States, 55126
United States, Nevada
Lovelace Scientific Resources
Las Vegas, Nevada, United States, 89014
United States, New Hampshire
Endocrinology and Diabetes Consultants, PC
Dover, New Hampshire, United States, 03820
United States, New Jersey
Radiant Reseach-Moorestown
Moorestown, New Jersey, United States, 08057
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Physician Clinical Research Service
White Plains, New York, United States, 10605
United States, North Carolina
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, United States, 28207
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236
MFP Research, Inc.
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97201
United States, South Carolina
Medical University of South Carolina, Division of Clinical Pharmacology
Charleston, South Carolina, United States, 29425
Costal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
TriCities Medical Reseach
Bristol, Tennessee, United States, 37620
United States, Texas
Diabetes $ Glandular Disease Clinic, PA
San Antonio, Texas, United States, 78229-4810
United States, Utah
Endocrine and Diabetes
Ogden, Utah, United States, 84403
United States, Virginia
National Clinical Research
Richmond, Virginia, United States, 23294
Salem Veterans Affairs Medical Center (151)
Salem, Virginia, United States, 24153
The Chase Wellness Center, Inc.
Virginia Beach, Virginia, United States, 23455
Argentina
Sanofi-aventis Administrative Office
Buenos Aires, Argentina
Belgium
Sanofi-aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
Finland
Sanofi-aventis Administrative Office
Helsinki, Finland
France
Sanofi-aventis Administrative Office
Paris, France
Germany
Sanofi-aventis Administrative Office
Berlin, Germany
Netherlands
Sanofi-aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-aventis Administrative office
Warszawa, Poland
United Kingdom
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Additional Information:
Publications:
Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC4736
Study First Received: January 23, 2002
Last Updated: April 17, 2009
ClinicalTrials.gov Identifier: NCT00029848     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Diabetes
Obesity

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009