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Obese Patients with Type 2 Diabetes - Article


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Clinical Trial: Obese Patients with Type 2 Diabetes

This study has been completed.

Sponsored by: Sanofi-Synthelabo
Information provided by: Sanofi-Synthelabo

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 Treatment or Intervention Phase
Obesity
Diabetes Mellitus, Non-Insulin-Dependent
Obesity in Diabetes
 Drug: Rimonabant
Phase III

MedlinePlus related topics:  Diabetes;   Obesity

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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

Further Study Details: 

Expected Total Enrollment:  370

Study start: September 2001;  Study completion: March 2003

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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)

Location Information


Alabama
      Innovative Clinical Trials, Birmingham,  Alabama,  35209,  United States

Arizona
      Advanced Clinicla Therapeutics, LLC, Tucson,  Arizona,  85712,  United States

      Lovelace Scientific Resources, Phoenix,  Arizona,  85016,  United States

California
      Southern California Prevention and Research Center Inc. (SPARC), Encino,  California,  91436,  United States

      Diablo Clinical Research, Inc., Walnut Creek,  California,  94598,  United States

      Anderson Clinical Research, San Bernardino,  California,  92408,  United States

Connecticut
      North East Clinical Research, Hamden,  Connecticut,  06518,  United States

Florida
      Jacksonville Center for Clinical Research, Jacksonville,  Florida,  32216,  United States

      Orlando Clinical Research Center, Orlando,  Florida,  32806,  United States

      Clinical Research of South Florida, Coral Gables,  Florida,  33134,  United States

      Comprehensive NeuroScience, Inc., Sarasota,  Florida,  34232,  United States

      DMI Helathcare Group, Largo,  Florida,  33773,  United States

      Metabolic Research Institute, West Palm Beach,  Florida,  33401,  United States

      Jackson Downey, MD, Jacksonville,  Florida,  32205,  United States

      University Clinical Research, Pembroke Pines,  Florida,  33024,  United States

      Jacksonville Center for Clinical Research, Jacksonville,  Florida,  32205,  United States

Georgia
      nTouch Research, Marietta,  Georgia,  30066,  United States

      CSRA Partners in Health, Inc., Augusta,  Georgia,  30909,  United States

Indiana
      Physicians Research Group, Indianapolis,  Indiana,  46250,  United States

      MediSphere Medical Research Center, LLC, Evansville,  Indiana,  47714,  United States

Kansas
      Kansas University Medical Center, Kansas City,  Kansas,  66160,  United States

Louisiana
      Medical Research Institute, Slidell,  Louisiana,  70458,  United States

      Gulf States Clinical Trails, LLC, Kenner,  Louisiana,  70062,  United States

Maine
      Androscoggin Cardiology Associates, Auburn,  Maine,  United States

Massachusetts
      Phase III Clinical Research, Fall River,  Massachusetts,  02720,  United States

      JM Clinical Trials, Inc., Swansea,  Massachusetts,  02777,  United States

Minnesota
      Twin Cities Clinical Research, Arden Hills,  Minnesota,  55126,  United States

Nevada
      Lovelace Scientific Resources, Las Vegas,  Nevada,  89014,  United States

New Hampshire
      Endocrinology and Diabetes Consultants, PC, Dover,  New Hampshire,  03820,  United States

New Jersey
      Radiant Reseach-Moorestown, Moorestown,  New Jersey,  08057,  United States

New Mexico
      Lovelace Scientific Resources, Albuquerque,  New Mexico,  87108,  United States

New York
      Physician Clinical Research Service, White Plains,  New York,  10605,  United States

North Carolina
      Center for Nutrition and Preventive Medicine, Charlotte,  North Carolina,  28207,  United States

Ohio
      Radiant Research, Cincinnati,  Ohio,  45236,  United States

      MFP Research, Inc., Cincinnati,  Ohio,  45242,  United States

Oklahoma
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States

Oregon
      Radiant Research, Portland,  Oregon,  97201,  United States

South Carolina
      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

Tennessee
      TriCities Medical Reseach, Bristol,  Tennessee,  37620,  United States

Texas
      Diabetes $ Glandular Disease Clinic, PA, San Antonio,  Texas,  78229-4810,  United States

Utah
      Endocrine and Diabetes, Ogden,  Utah,  84403,  United States

Virginia
      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

More Information

http://sanofi-synthelabous.com

http://centerwatch.com

Study ID Numbers:  EFC4736; SR141716
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  January 23, 2002
ClinicalTrials.gov Identifier:  NCT00029848
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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