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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT01548651
Eligibility Criteria:
Inclusion Criteria:
* Men and women with a diagnosis diagnosis of Impaired Glucose Tolerance i.e. fasting plasma glucose less than or equal to 125 mg/dl, 2 hour post 75 gram oral glucose tolerance test (OGTT) plasma glucose between 140-199 mg/dl, glycosylated hemoglobin A1c (HbA1c) less than 6.5% as per American Diabetes Association (ADA) criteria.
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
Exclusion Criteria:
* Patients must not be on anti-diabetes therapy for treatment of Impaired Glucose Tolerance (IGT) and must have a fasting plasma glucose concentration less or equal to 125 mg/dl.
* Type 1 or Type 2 diabetes mellitus (fasting plasma glucose greater than 125 mg/dl).
* Patients must not be on or have received metformin, thiazolidinediones, sulfonylureas, DPP IV inhibitor, or exenatide/liraglutide treatment for treatment of IGT at any time. Patients must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications such as hormone replacement therapy with known adverse effects on glucose tolerance levels. Patients taking systemic glucocorticoids will also be excluded.
* Subjects with a history of clinically significant heart disease, peripheral vascular disease, or pulmonary disease.
* Subjects must have a Body Mass Index between 30-35 kg/m2 and stable body weight.
* Subjects must not have clinically significant liver disease (aspartate aminotransferase (AST) \< 2.5 times upper limit of normal, Alanine transaminase (ALT) \< 2.5 times upper limit of normal, Alkaline phosphatase\< 2.5 times upper limit of normal), kidney disease (Serum creatinine \< 1.5 mg/dl in men and 1.4 mg/dl in women) or significant anemia (Hematocrit \< 34 vol%).
* Subjects with a history of any serious hypersensitivity reaction to saxagliptin or a dipeptidyl peptidase 4 (DPP-IV) inhibitor.
* Concomitant treatment with systemic cytochrome P450 3A4 inducers.
* Women who are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01548651
Study Brief:
Protocol Section:
NCT01548651