Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Inclusion Criteria:

- Men or women ≥18 years of age

- Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes
Association

- Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent
very high albuminuria at the Run-In and Screening Visit

- Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin
receptor blocker (ARB) at maximal tolerated labeled dose without adjustments

- Serum potassium <=4.8 mmol/L

Exclusion Criteria:

- Confirmed significant non-diabetic renal disease, including clinically relevant renal
artery stenosis

- Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP)
≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or
mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)

- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and
persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit
[class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)]

- Dialysis for acute renal failure within 12 weeks of Run-in visit

- Renal allograft in place or scheduled kidney transplant within next 12 months

- Glycated hemoglobin (HbA1c) >12%.