Obese Patients With Type 2 Diabetes (RIO-Diabetes)

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Obese Patients With Type 2 Diabetes (RIO-Diabetes)

This study has been completed.
Sponsored by: 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

MedlinePlus related topics: Diabetes Obesity
Drug Information available for: Rimonabant SR 141716A
U.S. FDA Resources
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 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

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-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis

Related Info

Publications of Results:
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. Erratum in: Lancet. 2006 Nov 11;368(9548):1650.

Responsible Party:sanofi-aventis ( ICD Study Director )
Study ID Numbers:EFC4736, SR141716
First Received:January 23, 2002
Last Updated:June 6, 2008
ClinicalTrials.gov Identifier:NCT00029848 [history]
Health Authority:United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Diabetes
Obesity

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder