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Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise (SOLO)

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00478972
First received: May 24, 2007
Last updated: July 17, 2009
Last verified: July 2009
History of Changes
  Purpose

The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.

The secondary objectives are:

  • To evaluate the effect of SR141716 compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters
  • To evaluate the safety and tolerability of SR141716 compared to placebo
  • To evaluate the pharmacokinetics of SR141716

Condition Intervention Phase
Obesity
Diabetes Mellitus Type 2
 Drug: rimonabant (SR141716)
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change in HbA1C from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Relative change in body weight from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change, in Fasting Plasma Glucose and in waist circumference from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Relative change in Triglycerides and HDL-cholesterol from baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Safety: adverse events, laboratory tests, vital signs [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Enrollment: 321
Study Start Date: May 2007
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rimonabant (SR141716)
oral administration
Placebo Comparator: 2 Drug: placebo
oral administration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
  • HbA1C ≥ 7.0 % and ≤ 10.0 %
  • Body Mass Index ≥ 25 kg/m²

Exclusion Criteria:

  • Type 1 diabetes
  • Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
  • Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
  • Secondary obesity
  • Primary hyperlipidemia
  • Positive serum pregnancy test in females of childbearing potential

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478972

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00478972     History of Changes
Other Study ID Numbers: EFC6648
Study First Received: May 24, 2007
Last Updated: July 17, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

Keywords provided by Sanofi:
obese
diabetes
cannabinoid-1 receptor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013