SOLO: Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
Study Details
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:
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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;
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To evaluate the safety and tolerability of Rimonabant compared to placebo;
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To evaluate the pharmacokinetics of Rimonabant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rimonabant Rimonabant 20 mg once daily in addition to diet and exercise |
Drug: Rimonabant
Tablet, oral administration
Other Names:
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 |
Drug: placebo (for Rimonabant)
Tablet, oral administration
Other: Diet and exercise
Target daily caloric intake: Ideal body weight × 25 kcal
|
Outcome Measures
Primary Outcome Measures
- Absolute change from baseline in HbA1C [Baseline to Week 36]
- Relative change from baseline in body weight [Baseline to Week 36]
Secondary Outcome Measures
- Absolute change from baseline in Fasting Plasma Glucose [Baseline to Week 36]
- Absolute change from baseline in waist circumference [Baseline to Week 36]
- Relative change from baseline in Triglycerides and HDL-cholesterol [Baseline to Week 36]
- Safety: Overview of adverse events [Baseline to Week 47]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
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HbA1C ≥ 7.0 % and ≤ 10.0 %
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Body Mass Index ≥ 25 kg/m²
Exclusion Criteria:
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Type 1 diabetes
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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
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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
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Secondary obesity
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Primary hyperlipidemia
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Tokyo | Japan |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: ICD CSD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EFC6648