Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00325650
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00325650
Study Brief:
Protocol Section:
NCT00325650