Status:
COMPLETED
Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, trig...
Detailed Description
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).
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00288236
Start Date
January 1 2006
End Date
July 1 2007
Last Update
April 7 2009
Active Locations (12)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Buenos Aires, Argentina
3
Sanofi-Aventis
Lane Cove, Australia
4
Sanofi-Aventis
Laval, Canada