Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

Bayer823 enrolled

Overview

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

823

Conditions

Diabetic Nephropathies

Interventions

Finerenone (BAY94-8862)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country * Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active. * Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria * are on oral antidiabetics and / or insulin, * have a documented fasting glucose \>/= 7.0 mmol/L in the medical history, * have a 2 hour plasma glucose \>/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or * have a glycated hemoglobin (HbA1c) \>/=6.5% \[National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)\] in the medical history or at the run-in visit * Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria: * Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of \>/=300 mg/g ( \>/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or * Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g in (\>/=3.4mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m² * Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit * Serum potassium \</= 4.8 mmol/L at both the run-in visit and the screening visit Exclusion Criteria: * Non-diabetic renal disease * Glycated hemoglobin (HbA1c) \>12% at the run-in visit or the screening visit * UACR \>3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit * Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean supine SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit * Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit * Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic * Dialysis for acute renal failure within the previous 6 months prior to the run-in visit

Locations (147)

Outcomes

Primary Outcomes

Ratio of UACR at Day 90 to UACR at Baseline

Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.