NCT00325650TerminatedPhase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Both)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Sanofi
- Enrollment
- 2,420
- Locations
- 1
- Primary Endpoint
- Time of progression to type 2 diabetes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
Rimonabant
Experimental
Rimonabant 20 mg once daily
Intervention: Rimonabant (Drug)
Placebo
Placebo Comparator
Placebo (for Rimonabant) once daily.
Intervention: Placebo (for Rimonabant) (Drug)
Outcomes
Primary Outcomes
Time of progression to type 2 diabetes
Time Frame: Baseline to 30 months
Secondary Outcomes
- Change from baseline in glucose and insulin at 2 hour post-glucose load(Baseline to 30 months)
- Change from baseline in waist circumference(Baseline to 30 months)
- Change from baseline in body weight(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 HDL-Cholesterol and triglycerides (TG)(Baseline to 30 months)
Investigators
Study Sites (1)
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