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and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy","A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy","ARTS-DN","Inclusion Criteria:\n\n* Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country\n* 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.\n* Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria\n\n  * are on oral antidiabetics and \u002F or insulin,\n  * have a documented fasting glucose \\>\u002F= 7.0 mmol\u002FL in the medical history,\n  * have a 2 hour plasma glucose \\>\u002F=11.1 mmol\u002FL during an oral glucose tolerance test in the medical history, or\n  * have a glycated hemoglobin (HbA1c) \\>\u002F=6.5% \\[National Glycohemoglobin Standardization Program (NGSP) \u002F Diabetes Control and Complications Trial (DCCT)\\] in the medical history or at the run-in visit\n* Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:\n\n  * Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of \\>\u002F=300 mg\u002Fg ( \\>\u002F= 34 mg\u002Fmmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \\>\u002F=30 mL\u002Fmin\u002F1.73 m² but \\\u003C 90 mL\u002Fmin\u002F1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or\n  * Persistent high albuminuria defined as UACR of \\>\u002F=30 mg\u002Fg but \\\u003C300 mg\u002Fg in (\\>\u002F=3.4mg\u002Fmmol but \\\u003C34 mg\u002Fmmol) in 2 out of 3 first morning void samples and eGFR \\>\u002F=30 mL\u002Fmin\u002F1.73 m² but \\\u003C 90 mL\u002Fmin\u002F1.73m²\n* Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and\u002For 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\n* Serum potassium \\\u003C\u002F= 4.8 mmol\u002FL at both the run-in visit and the screening visit\n\nExclusion Criteria:\n\n* Non-diabetic renal disease\n* Glycated hemoglobin (HbA1c) \\>12% at the run-in visit or the screening visit\n* UACR \\>3000 mg\u002Fg (339mg\u002Fmmol) in any of the urinary first morning void samples at the run-in visit or screening visit\n* Hypertension with mean sitting systolic blood pressure (SBP) \\>\u002F=180 mmHg or mean sitting diastolic blood pressure (DBP) \\>\u002F=110 mmHg at the run-in visit or mean supine SBP \\>\u002F=160 mmHg or mean sitting DBP \\>\u002F=100 mmHg at the screening visit\n* 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\n* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic\n* Dialysis for acute renal failure within the previous 6 months prior to the run-in visit",false,"ALL","18 Years",{"count":1252,"type":1253},823,"ACTUAL","INTERVENTIONAL",[1256],"PHASE2","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.",[1259],"Diabetic Nephropathies","COMPLETED","2021-06-30",{"date":1263,"type":1253},"2021-07-01",{"date":1265,"type":1253},"2013-06-12",{"date":1267,"type":1253},"2014-08-07",{"name":5,"class":6},147]