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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014