Clinical trial NCT00325650: Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prediabetic State
Keywords: Prediabetic state
Impaired fasting glucose
Impaired glucose Tolerance
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-15
Enrollment: 2420
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Time of progression to type 2 diabetes
timeFrame: Baseline to 30 months
Secondary outcomes:
measure: Change from baseline in body weight
timeFrame: Baseline to 30 months
measure: Change from baseline in waist circumference
timeFrame: Baseline to 30 months
measure: Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)
timeFrame: Baseline to 30 months
measure: Change from baseline in glucose and insulin at 2 hour post-glucose load
timeFrame: Baseline to 30 months
measure: Change from baseline in HDL-Cholesterol and triglycerides (TG)
timeFrame: Baseline to 30 months
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: