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)
Status and phase
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Treatments
Study type
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Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
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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.
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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
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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
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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
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
823 participants in 8 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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