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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)
Information provided by (Responsible Party):
Sanofi Identifier:
First received: May 24, 2007
Last updated: June 6, 2016
Last verified: June 2016

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) 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 Rimonabant 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 Rimonabant compared to placebo;
  • To evaluate the pharmacokinetics of Rimonabant.

Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: Rimonabant
Drug: placebo (for Rimonabant)
Other: Diet and exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change from baseline in HbA1C [ Time Frame: Baseline to Week 36 ]
  • Relative change from baseline in body weight [ Time Frame: Baseline to Week 36 ]

Secondary Outcome Measures:
  • Absolute change from baseline in Fasting Plasma Glucose [ Time Frame: Baseline to Week 36 ]
  • Absolute change from baseline in waist circumference [ Time Frame: Baseline to Week 36 ]
  • Relative change from baseline in Triglycerides and HDL-cholesterol [ Time Frame: Baseline to Week 36 ]
  • Safety: Overview of adverse events [ Time Frame: Baseline to Week 47 ]

Enrollment: 321
Study Start Date: April 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rimonabant
Rimonabant 20 mg once daily in addition to diet and exercise
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia
Other: Diet and exercise
Target daily caloric intake: Ideal body weight × 25 kcal
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily in addition to diet and exercise
Drug: placebo (for Rimonabant)
Tablet, oral administration
Other: Diet and exercise
Target daily caloric intake: Ideal body weight × 25 kcal

Detailed Description:
The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00478972

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

Responsible Party: Sanofi Identifier: NCT00478972     History of Changes
Other Study ID Numbers: EFC6648
Study First Received: May 24, 2007
Last Updated: June 6, 2016

Keywords provided by Sanofi:
cannabinoid-1 receptor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017