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

Stopped early · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00449605

Run by

Sanofi

People needed

508

Starts

2007-03-01

Expected to finish

2009-03-01

Last updated by the study team

2016-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Seoul, South Korea
• Sanofi-Aventis Administrative Office — Barcelona, Spain
• Sanofi-Aventis Administrative Office — Bromma, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.