Obese Patients With Type 2 Diabetes - Full Text View

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:

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

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

Show 55 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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
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 09, 2009