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

April 6, 2009 updated by: Sanofi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis
  • Australia
      • Lane Cove, Australia
        • Sanofi-Aventis
  • Canada
      • Laval, Canada
        • Sanofi-Aventis
  • Chile
      • Providencia, Chile
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis
  • Italy
      • Milano, Italy
        • Sanofi-Aventis
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis
  • United Kingdom
      • Guildford, United Kingdom
        • Sanofi-Aventis
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Absolute change in HbA1C from baseline to Week 48

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 6, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5593

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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