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

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

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

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).

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).