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Obese Patients With Type 2 Diabetes (RIO-Diabetes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00029848
Recruitment Status : Completed
First Posted : January 24, 2002
Last Update Posted : April 20, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE January 23, 2002
First Posted Date  ICMJE January 24, 2002
Last Update Posted Date April 20, 2009
Study Start Date  ICMJE October 2001
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)		 Change in body weight
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2008)		 Metabolic parameters
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Obesity in Diabetes
Intervention  ICMJE Drug: Rimonabant (SR141716)
Study Arms  ICMJE Not Provided
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. doi: 10.1016/S0140-6736(06)69571-8. Erratum In: Lancet. 2006 Nov 11;368(9548):1650.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2008)		 1045
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		 370
Actual Study Completion Date  ICMJE May 2004
Actual 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Canada,   Czech Republic,   Finland,   France,   Germany,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00029848
Other Study ID Numbers  ICMJE EFC4736
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ICD Study Director, sanofi-aventis
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Sanofi-Synthelabo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2009

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