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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00288236
First received: February 6, 2006
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Rimonabant (SR141716)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change in HbA1C from baseline to Week 48

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

Enrollment: 368
Study Start Date: January 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288236

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis
Buenos Aires, Argentina
Australia
Sanofi-Aventis
Lane Cove, Australia
Canada
Sanofi-Aventis
Laval, Canada
Chile
Sanofi-Aventis
Providencia, Chile
France
Sanofi-Aventis
Paris, France
Germany
Sanofi-Aventis
Berlin, Germany
Italy
Sanofi-Aventis
Milano, Italy
Netherlands
Sanofi-Aventis
Gouda, Netherlands
Russian Federation
Sanofi-Aventis
Moscow, Russian Federation
South Africa
Sanofi-Aventis
Midrand, South Africa
United Kingdom
Sanofi-Aventis
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00288236     History of Changes
Other Study ID Numbers: EFC5593
Study First Received: February 6, 2006
Last Updated: April 6, 2009
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Sanofi:
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014