Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00288236
- Lead Sponsor
- Sanofi
- 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, triglycerides - Safety, tolerability
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Absolute change in HbA1C from baseline to Week 48
- Secondary Outcome Measures
Name Time Method Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).
Trial Locations
- Locations (1)
Sanofi-Aventis
🇬🇧Guildford, United Kingdom