Prediabetic State
Conditions
Keywords
Prediabetic state, Impaired fasting glucose, Impaired glucose Tolerance
Brief summary
Primary objective: To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline). Secondary objectives: * To assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG), * To assess the effect on quality of life * To evaluate long term safety and tolerability.
Detailed description
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.
Interventions
DRUGRimonabant
Tablet, oral administration
Tablet, oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* No previous history of treatment for type 2 diabetes. * Diagnosis of : * Impaired Glucose Tolerance (IGT) based on one oral glucose tolerance test (OGTT) and defined as a 2 hour post-challenge glucose (after a 75-g Oral Glucose Tolerance Test) \> 140 mg/dL (7.8 mmol/L) but \< 200 mg/dL (11.1 mmol/L), at the screening visit. * And / or impaired fasting glucose (IFG) based on a Fasting Plasma Glucose (FPG) ³ 100 mg/dL (5.6 mmol/L) and \< 126 mg/dL (7.0 mmol/L), at the screening visit.
Exclusion criteria
* Absence of effective contraceptive method for females of childbearing potential. * Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit. * 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. * Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. * Related to laboratory findings: * positive test for hepatitis B surface antigen and/or hepatitis C antibody; * Positive urine pregnancy test in females of childbearing potential ; * Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range. * Related to previous or concomitant medications: * Within 3 months prior to screening visit and/or during the screening period: * anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc), * systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of progression to type 2 diabetes | Baseline to 30 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in body weight | Baseline to 30 months |
| Change from baseline in waist circumference | Baseline to 30 months |
| Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) | Baseline to 30 months |
| Change from baseline in glucose and insulin at 2 hour post-glucose load | Baseline to 30 months |
| Change from baseline in HDL-Cholesterol and triglycerides (TG) | Baseline to 30 months |
Countries
United States
Outcome results
None listed