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Obese Patients With Type 2 Diabetes (RIO-Diabetes)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00029848
First received: January 23, 2002
Last updated: April 17, 2009
Last verified: April 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

  Show 55 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:

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

Keywords provided by Sanofi:
Diabetes
Obesity

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

ClinicalTrials.gov processed this record on May 21, 2013