Obese Patients With Type 2 Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

January 23, 2002

Last Updated Date

April 17, 2009

Start Date ^ICMJE

October 2001

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in body weight

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00029848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metabolic parameters

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Obese Patients With Type 2 Diabetes

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity
Diabetes Mellitus, Non-Insulin-Dependent
Obesity in Diabetes

Intervention ^ICMJE

Drug: Rimonabant (SR141716)

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1045

Completion Date

May 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Belgium, Canada, Czech Republic, Finland, France, Germany, Netherlands, Poland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00029848

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC4736

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP