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
• Trial end date: 2014-08-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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