Obese Patients With Type 2 Diabetes (RIO-Diabetes)

April 17, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1045

Phase

  • Phase 3

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

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

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in body weight

Secondary Outcome Measures

Outcome Measure
Metabolic parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2001

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

January 23, 2002

First Submitted That Met QC Criteria

January 23, 2002

First Posted (Estimate)

January 24, 2002

Study Record Updates

Last Update Posted (Estimate)

April 20, 2009

Last Update Submitted That Met QC Criteria

April 17, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC4736

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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