Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes (RAPSODI)

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Prediabetic State

Treatments

Drug: Placebo (for Rimonabant)

Drug: Rimonabant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325650

EFC5107

Details and patient eligibility

About

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.

Full description

The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.

Enrollment

2,420 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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;