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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT02537834
Eligibility Criteria:
Inclusion Criteria:
* The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)
* The subject with hemoglobin A1c ≧7.5% - \<10.5 %
* The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test
Exclusion Criteria:
* The subject with type 1 diabetes mellitus
* The subject with Pregnancy or lactation
* The subject with Fasting Plasma Glucose ≧ 270 mg/dl
* The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening
* The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months
* The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women
* The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility
* The subject has received treatment with another investigational product or non-approved drug 3 months before screening
* The subject with history of Tofogliflozin therapy
* The subject with estimated glomerular filtration rate of \<30 mL/min/1.73 m\^2
* The subject who frequently experiencing orthostatic hypotension
* The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg
* The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02537834
Study Brief:
Protocol Section:
NCT02537834