Diabetes Mellitus, Type 2
Conditions
Keywords
Rimonabant/metformin combination
Brief summary
The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months. Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.
Detailed description
The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.
Interventions
DRUGRimonabant
Tablet, oral administration
DRUGMetformin
Tablet, oral administration
DRUGplacebo
Tablet, oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria) * Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients * A1C ≥7.0 % and ≤10.0 % * Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)
Exclusion criteria
* Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit * In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days * Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders * Presence or history of cancer within the past five years * Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control 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 A1C | at 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | at 9 months |
| Change from baseline in body weight | at 9 months |
| Percent change from baseline in triglycerides | at 9 months |
| Percent change from baseline in HDL-C | at 9 months |
Countries
United States
Outcome results
None listed