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Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug (SYMPHONY)

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00478595
First received: May 24, 2007
Last updated: June 1, 2016
Last verified: June 2016
  Purpose

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 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).

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
Obesity
Diabetes Mellitus Type 2
Drug: Rimonabant
Drug: Placebo (for Rimonabant)
Drug: Anti-diabetic monotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients on Monotherapy Inadequately Controlled With Oral Anti-diabetic Drug

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change from baseline in HbA1C [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Relative change from baseline in in body weight [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change from baseline in Fasting Plasma Glucose [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Absolute change from baseline in waist circumference [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Relative change from baseline in Triglycerides and HDL-cholesterol [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Safety: overview of adverse events [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: Yes ]

Enrollment: 458
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rimonabant
Rimonabant 20 mg once daily
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia
Drug: Anti-diabetic monotherapy
Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily
Drug: Placebo (for Rimonabant)
Tablet, oral administration
Drug: Anti-diabetic monotherapy
Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period

Detailed Description:
The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)
  • 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 (other than a sulfonylurea or alpha-glucosidase inhibitor) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478595

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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00478595     History of Changes
Other Study ID Numbers: EFC6647 
Study First Received: May 24, 2007
Last Updated: June 1, 2016
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rimonabant
Hypoglycemic 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

ClinicalTrials.gov processed this record on December 07, 2016