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

Inclusion Criteria:

- Men or women ≥18 years of age

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

- Diagnosis of diabetic kidney disease (DKD) with persistent high albuminuria or
persistent very high albuminuria at the Run-in and Screening visits:

- 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, sitting diastolic blood pressure (DBP) ≥110 mmHg at run in visit, or mean
sitting SBP ≥160 mmHg, 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%.