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

Obesity Clinical Trial

— SYMPHONY  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00478595
• Other study ID #: EFC6647
• Status: Terminated
• Phase: Phase 3
• First received: May 24, 2007
• Last updated: July 17, 2009
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 458
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Drug:
• rimonabant (SR141716)
one tablet/day
• Placebo
one tablet/day

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in HbA1C from baseline		week 52	No
Primary	Relative change in body weight from baseline		week 52	No
Secondary	Absolute change, in Fasting Plasma Glucose and in waist circumference from baseline		week 52	No
Secondary	Relative change in Triglycerides and HDL-cholesterol from baseline		week 52	No
Secondary	Safety: adverse events, laboratory tests, vital signs		study period	Yes