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

June 6, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rimonabant
Rimonabant 20 mg once daily in addition to diet and exercise
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • Acomplia
  • SR141716
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
Other: Diet and exercise
Target daily caloric intake: Ideal body weight × 25 kcal
Drug: placebo (for Rimonabant)
Tablet, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in HbA1C
Time Frame: Baseline to Week 36
Baseline to Week 36
Relative change from baseline in body weight
Time Frame: Baseline to Week 36
Baseline to Week 36

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (ESTIMATE)

May 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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