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



Status:Completed
Conditions:Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2013
End Date:August 2014

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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

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


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
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
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