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

Obesity Clinical Trial

— SOLO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00478972
• Other study ID #: EFC6648
• Status: Terminated
• Phase: Phase 3
• First received: May 24, 2007
• Last updated: June 6, 2016
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: June 2016
• 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 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 321
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rimonabant
Tablet, oral administration
• placebo (for Rimonabant)
Tablet, oral administration

Other:
• Diet and exercise
Target daily caloric intake: Ideal body weight × 25 kcal

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 from baseline in HbA1C		Baseline to Week 36	No
Primary	Relative change from baseline in body weight		Baseline to Week 36	No
Secondary	Absolute change from baseline in Fasting Plasma Glucose		Baseline to Week 36	No
Secondary	Absolute change from baseline in waist circumference		Baseline to Week 36	No
Secondary	Relative change from baseline in Triglycerides and HDL-cholesterol		Baseline to Week 36	No
Secondary	Safety: Overview of adverse events		Baseline to Week 47	Yes