Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Metformin
Brief 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.
Interventions
DRUGRimonabant
Tablet, oral administration
DRUGGlimepiride
Tablet, oral administration
DRUGMetformin
Metformin continued at stable dose as background therapy
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in glycemic measure HbA1c | 52 weeks (1 year) |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in body weight | 52 weeks |
| Relative change from baseline in HDL-C | 52 weeks |
Countries
Chile, Denmark, Finland, Hungary, India, Italy, Mexico, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, United States
Outcome results
None listed