Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise (SOLO)
Primary Purpose
Obesity, Diabetes Mellitus Type 2
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Rimonabant
placebo (for Rimonabant)
Diet and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obese, diabetes, cannabinoid-1 receptor
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rimonabant
Placebo
Arm Description
Rimonabant 20 mg once daily in addition to diet and exercise
Placebo (for Rimonabant) once daily in addition to diet and exercise
Outcomes
Primary Outcome Measures
Absolute change from baseline in HbA1C
Relative change from baseline in body weight
Secondary Outcome Measures
Absolute change from baseline in Fasting Plasma Glucose
Absolute change from baseline in waist circumference
Relative change from baseline in Triglycerides and HDL-cholesterol
Safety: Overview of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478972
Brief Title
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Company decision taken in light of demands by certain national health authorities
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus Type 2
Keywords
obese, diabetes, cannabinoid-1 receptor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rimonabant
Arm Type
Experimental
Arm Description
Rimonabant 20 mg once daily in addition to diet and exercise
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for Rimonabant) once daily in addition to diet and exercise
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Other Intervention Name(s)
SR141716, Acomplia
Intervention Description
Tablet, oral administration
Intervention Type
Drug
Intervention Name(s)
placebo (for Rimonabant)
Intervention Description
Tablet, oral administration
Intervention Type
Other
Intervention Name(s)
Diet and exercise
Intervention Description
Target daily caloric intake: Ideal body weight × 25 kcal
Primary Outcome Measure Information:
Title
Absolute change from baseline in HbA1C
Time Frame
Baseline to Week 36
Title
Relative change from baseline in body weight
Time Frame
Baseline to Week 36
Secondary Outcome Measure Information:
Title
Absolute change from baseline in Fasting Plasma Glucose
Time Frame
Baseline to Week 36
Title
Absolute change from baseline in waist circumference
Time Frame
Baseline to Week 36
Title
Relative change from baseline in Triglycerides and HDL-cholesterol
Time Frame
Baseline to Week 36
Title
Safety: Overview of adverse events
Time Frame
Baseline to Week 47
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Tokyo
Country
Japan
12. IPD Sharing Statement
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Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
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