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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02345057
Eligibility Criteria:
Inclusion Criteria:
* Subjects with type 2 diabetes mellitus
* Male or female subjects aged 20 years or older at informed consent
* Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and \< 300 mg/g Cr
* Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m\^2
* Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period
Exclusion Criteria:
* Type 1 diabetes
* HbA1c (NGSP) \>=8.4%
* Secondary glucose intolerance
* Subjects diagnosed with non-diabetic nephropathy
* Nephrotic syndrome
* Secondary hypertension or malignant hypertension
* Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m\^2 and \< 45 mL/min/1.73 m\^2, serum potassium level of \< 3.5 mEq/L or ≥ 4.8 mEq/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02345057
Study Brief:
Protocol Section:
NCT02345057