Obese Patients With Type 2 Diabetes - Full Text View

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

ChemIDplus related topics:

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

More Information

Related Info This link exits the ClinicalTrials.gov site

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
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

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00029848