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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2007

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).

Interventions

  • Drug: Rimonabant (SR141716)
  • Drug: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Absolute change in HbA1C from baseline to Week 48

Secondary Measures

  • Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • ICD Study Director, sanofi-aventis
  • Overall Official(s)
    • ICD CSD, Study Director, Sanofi

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