Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)

Study Overview
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Brief Summary
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Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability

Detailed Description
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The total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 months).

Official Title
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A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/Day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled With Insulin

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Rimonabant (SR141716)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged greater than or equal to 18 years. Diagnosis of type 2 diabetes as defined by WHO criteria. Type 2 diabetes treated with insulin for at least 3 months (insulin dose of at least 30 U/day for at least 4 weeks). HbA1C greater than or equal to 7%. Having signed the informed consent form. Exclusion Criteria: General: Weight loss > 5 kg within 3 months prior to screening visit. Pregnancy or lactation. Absence of medically approved contraceptive methods for females of childbearing potential. Administration of other investigational drugs within 30 days prior to screening visit. Previous participation in a Rimonabant study. Presence or history of allergic reaction or intolerance to multiple drugs. Related to endocrine and metabolic disorders: Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit. Fasting C-peptide < 1.0 ng/mL. Related to other disorders: Presence of any severe medical or psychological condition that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study. Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. Related to laboratory findings: Positive test for hepatitis B surface antigen and/or hepatitis C antibody. Abnormal TSH level (TSH > ULN or < LLN). Positive urine pregnancy test. Related to previous or concomitant medications: Antidiabetic drugs other than insulin within 3 months prior to screening visit. Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rimonabant (SR141716)|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in HbA1C from baseline to Week 48 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus