Diabetes Mellitus, Type 2
Conditions
Keywords
Randomized Controlled Trial, Metformin
Brief summary
The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes. Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.
Detailed description
The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.
Interventions
DRUGRimonabant
Tablet, oral administration
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
* History of type 2 diabetes * HbA1c between 7% to 10% at screening visit * Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit
Exclusion criteria
* Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss * Weight loss of more than 5 kg within 3 months prior to screening * Administration of other investigational drugs within 30 days prior to screening visit * Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant * Presence or history of cancer within the past five years * Pregnant or breast-feeding women * 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. 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 HbA1c | 36 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | 36 weeks |
| Change from baseline in body weight | 36 weeks |
| Percent change from baseline in HDL-C and Triglycerides | 36 weeks |
Countries
Indonesia, Lithuania, Malaysia, Mexico, Philippines, Poland, Romania, Russia, Slovakia, Taiwan, Thailand, Ukraine, United States
Outcome results
None listed