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Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00288236•Sanofi

View on ClinicalTrials.gov

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

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+10 more criteria

Locations (12)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Sanofi-Aventis

Buenos Aires, Argentina

Sanofi-Aventis

Lane Cove, Australia

Sanofi-Aventis

Laval, Canada

Sanofi-Aventis

Providencia, Chile

Sanofi-Aventis

Paris, France

Sanofi-Aventis

Berlin, Germany

Sanofi-Aventis

Milan, Italy

Sanofi-Aventis

Gouda, Netherlands

Sanofi-Aventis

Moscow, Russia

Key Dates

Start Date

January 1, 2006

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

April 7, 2009

Enrollment

368

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Rimonabant (SR141716)

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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