Obese Patients With Type 2 Diabetes

Obesity Clinical Trial

— RIO-Diabetes  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029848
• Other study ID #: EFC4736
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2002
• Last updated: April 17, 2009
• Start date: October 2001
• Est. completion date: May 2004

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1045
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

• 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)

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Obesity
• Obesity in Diabetes

Intervention

Drug:
• Rimonabant (SR141716)

Locations

Country	Name	City	State
Argentina	Sanofi-aventis Administrative Office	Buenos Aires
Belgium	Sanofi-aventis Administrative Office	Diegem
Canada	Sanofi-aventis Administrative Office	Laval
Czech Republic	Sanofi-aventis Administrative Office	Praha
Finland	Sanofi-aventis Administrative Office	Helsinki
France	Sanofi-aventis Administrative Office	Paris
Germany	Sanofi-aventis Administrative Office	Berlin
Netherlands	Sanofi-aventis Administrative Office	Gouda
Poland	Sanofi-aventis Administrative office	Warszawa
United Kingdom	Sanofi-aventis Administrative Office	Guildford Surrey
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Twin Cities Clinical Research	Arden Hills	Minnesota
United States	Androscoggin Cardiology Associates	Auburn	Maine
United States	CSRA Partners in Health, Inc.	Augusta	Georgia
United States	Innovative Clinical Trials	Birmingham	Alabama
United States	TriCities Medical Reseach	Bristol	Tennessee
United States	Medical University of South Carolina, Division of Clinical Pharmacology	Charleston	South Carolina
United States	Center for Nutrition and Preventive Medicine	Charlotte	North Carolina
United States	MFP Research, Inc.	Cincinnati	Ohio
United States	Radiant Research	Cincinnati	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Endocrinology and Diabetes Consultants, PC	Dover	New Hampshire
United States	Southern California Prevention and Research Center Inc. (SPARC)	Encino	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	North East Clinical Research	Hamden	Connecticut
United States	Physicians Research Group	Indianapolis	Indiana
United States	Jackson Downey, MD	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Gulf States Clinical Trails, LLC	Kenner	Louisiana
United States	DMI Helathcare Group	Largo	Florida
United States	Lovelace Scientific Resources	Las Vegas	Nevada
United States	nTouch Research	Marietta	Georgia
United States	Radiant Reseach-Moorestown	Moorestown	New Jersey
United States	Costal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Endocrine and Diabetes	Ogden	Utah
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Orlando Clinical Research Center	Orlando	Florida
United States	University Clinical Research	Pembroke Pines	Florida
United States	Lovelace Scientific Resources	Phoenix	Arizona
United States	Radiant Research	Portland	Oregon
United States	National Clinical Research	Richmond	Virginia
United States	Salem Veterans Affairs Medical Center (151)	Salem	Virginia
United States	Diabetes $ Glandular Disease Clinic, PA	San Antonio	Texas
United States	Anderson Clinical Research	San Bernardino	California
United States	Comprehensive NeuroScience, Inc.	Sarasota	Florida
United States	Medical Research Institute	Slidell	Louisiana
United States	JM Clinical Trials, Inc.	Swansea	Massachusetts
United States	Advanced Clinicla Therapeutics, LLC	Tucson	Arizona
United States	The Chase Wellness Center, Inc.	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Metabolic Research Institute	West Palm Beach	Florida
United States	Physician Clinical Research Service	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight
Secondary	Metabolic parameters