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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT01859793
Eligibility Criteria:
Inclusion Criteria:
1. Adult age 21-70 years of age.
2. Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%.
3. On stable metformin therapy for at least 6 weeks prior to enrollment.
4. Glycosylated Hemoglobin ≥6.2% and ≤ 9.5%.
Exclusion Criteria:
1. History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 50% on angiography or by confirmed history of myocardial infarction by standard criteria.)
2. Evidence of other evident major illness including chronic renal insufficiency (creatinine clearance less than 60 mL/min),chronic liver disease (AST or ALT greater than 2.5 x normal), or cancer currently undergoing systemic therapy or had systemic therapy for cancer within 1 year of enrollment.
3. Pregnancy as determined by urinary beta-HCG test
4. Illicit drug use (heroin, cocaine etc) in the past 1 year.
5. Alcohol abuse, defined as the equivalent of 14 beers/week for a man or 7 beers/week for a woman
6. History of allergy to DPP-4 inhibitors at the time of screening/enrollment
7. Prior history of pancreatitis
8. Patients currently on insulin or sulfonylurea therapy.
9. Patients currently on digoxin.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01859793
Study Brief:
Protocol Section:
NCT01859793