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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT02517320
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus
* Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%
* estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2
* The median UACR of the first morning void urine samples is ≥50 mg/g Cr and \<300 mg/g Cr
* Stable blood pressure(diastolic blood pressure (DBP) \<100 mmHg and stable systolic blood pressure (SBP) \<160 mmHg)
Exclusion Criteria:
* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
* A diagnosis of non-diabetic renal disease.
* A following serum potassium level.
* eGFR of 30-59mL/min/1.73m2; serum potassium level of \<3.5 or \>4.7 mmol/L,
* eGFR of ≥60mL/min/1.73m2: serum potassium level of \<3.5 or \>5.0 mmol/L
* symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)\<50mmHg and systolic blood pressure(SBP)\<110mmHg)
* QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
* New York Heart Association (NYHA) Class III or IV heart failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02517320
Study Brief:
Protocol Section:
NCT02517320