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A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin

NCT00449605•Sanofi

View on ClinicalTrials.gov

Summary

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

Detailed Description

The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients with legal age
•Body Mass Index \>27kg/m2
•Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin \>=1500 mg/day for at least three months
•HbA1c \>=7% and \<=9% at screening visit

Exclusion Criteria

•Weight loss \> 5 kg within three months prior to screening
•Presence of any clinically significant endocrine disease according to the Investigator
•Presence of type 1 diabetes
•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
•Previous participation in a clinical study with rimonabant
•Absence of effective medical contraceptive method for females of childbearing potential
•Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
•Within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
•Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (15)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-aventis adminsitrative office

Santiago, Chile

Sanofi-Aventis Administrative Office

Hørsholm, Denmark

Sanofi-Aventis Administrative Office

Helsinki, Finland

Sanofi-Aventis Administrative Office

Budapest, Hungary

Sanofi-Aventis Administrative Office

Mumbai, India

Sanofi-Aventis Administrative Office

Milan, Italy

Sanofi-Aventis Administrative Office

México, Mexico

Sanofi-Aventis Administrative Office

San Juan, Puerto Rico

Key Dates

Start Date

March 1, 2007

Primary Completion Date

November 1, 2008

Completion Date

March 1, 2009

Last Updated

May 16, 2016

Enrollment

508

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Rimonabant

DRUG

Glimepiride

DRUG

Metformin

DRUG

Sponsors

Lead Sponsor

Sanofi

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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: May 16, 2016Data 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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