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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00325650
Other study ID # EFC5107
Secondary ID
Status Terminated
Phase Phase 3
First received May 12, 2006
Last updated June 12, 2009
Start date May 2006
Est. completion date March 2009

Study information

Verified date June 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary: effect of long-term administration 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: Effect on weight loss and weight maintenance, sustained effect of rimonabant following a washout period, other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during OGTTs, other risk factors (HDL-Cholesterol, TG), quality of life - Safety and tolerability.


Recruitment information / eligibility

Status Terminated
Enrollment 2420
Est. completion date March 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 75 Years
Eligibility Inclusion Criteria:

- No previous history of treatment for type 2 diabetes.

- Diagnosis of :

- IGT based on one 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 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 ;

- 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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rimonabant (SR141716)
oral administration once daily
placebo
oral administration once daily

Locations

Country Name City State
United States Sanofi-Aventis Bridgewater New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of progression to type 2 diabetes study period No
Secondary Body weight, waist circumference, sustained effect following a washout period, HbA1C, fasting plasma glucose and 2-h post-glucose load plasma glucose, fasting insulin and 2-h post-glucose load insulin, HDL-Cholesterol and TG study period No
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