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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00998335
Eligibility Criteria:
Inclusion Criteria:
To participate patients must:
1. Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
2. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
3. Age range of 18 to 70 years (inclusive).
4. Patients must have been on a stable dose of allowed chronic medications for two months prior to entering the double-blind treatment period.
5. All participants must have the following laboratory values:
* Hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females
* Serum creatinine ≤ 1.5 mg/dl
* AST (SGOT) ≤ 2.5 times upper limit of normal
* ALT (SGPT) ≤ 2.5 times upper limit of normal
* Alkaline phosphatase ≤ 2.5 times upper limit of normal
Exclusion Criteria:
Patients will be excluded if any of the following criteria are present:
1. Individuals with type 1 diabetes or type 2 diabetes and a FPG ≥ 300 mg/dl.
2. Subjects on sulfonylureas, metformin and/or TZDs unless the dose has been stable for at least 2 months prior to study entry.
3. Patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. Patients taking systemic glucocorticoids will be excluded.
4. Past (within 1 year) or current history of alcohol abuse.
5. Patients will be excluded if there is a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00998335
Study Brief:
Protocol Section:
NCT00998335