Diabetes Mellitus Type 2, Obesity
Conditions
Keywords
obese, diabetes, cannabinoid-1 receptor
Brief summary
The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor). The secondary objectives are: * To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters; * To evaluate the safety and tolerability of Rimonabant compared to placebo; * To evaluate the pharmacokinetics of Rimonabant.
Detailed description
The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.
Interventions
DRUGRimonabant
Tablet, oral administration
Tablet, oral administration
DRUGAnti-diabetic monotherapy
Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor) * HbA1C ≥ 7.0 % and ≤ 10.0 % * Body Mass Index ≥ 25 kg/m²
Exclusion criteria
* Type 1 diabetes * Within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction * Within 4 weeks 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 * Secondary obesity * Primary hyperlipidemia * Positive serum pregnancy test in females of childbearing potential 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 |
|---|---|
| Absolute change from baseline in HbA1C | Baseline to week 52 |
| Relative change from baseline in in body weight | Baseline to week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in waist circumference | Baseline to week 52 |
| Relative change from baseline in Triglycerides and HDL-cholesterol | Baseline to week 52 |
| Absolute change from baseline in Fasting Plasma Glucose | Baseline to week 52 |
| Safety: overview of adverse events | Baseline to Week 56 |
Countries
Japan
Outcome results
None listed