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

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).