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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Obesity Diabetes Mellitus, Non-Insulin-Dependent Obesity in Diabetes Drug: Rimonabant (SR141716) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1045 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2001
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in body weight

Secondary Outcome Measures :
  1. Metabolic parameters

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029848


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Publications of Results:

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00029848    
Other Study ID Numbers: EFC4736
First Posted: January 24, 2002    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
Diabetes
Obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Rimonabant
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs