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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00288236
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : April 7, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Rimonabant (SR141716) Drug: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288236

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Buenos Aires, Argentina
Lane Cove, Australia
Laval, Canada
Providencia, Chile
Paris, France
Berlin, Germany
Milano, Italy
Gouda, Netherlands
Russian Federation
Moscow, Russian Federation
South Africa
Midrand, South Africa
United Kingdom
Guildford, United Kingdom
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00288236    
Other Study ID Numbers: EFC5593
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
Type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs