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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Nephropathies

In brief

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.

Key facts

Study ID

NCT01874431

Run by

Bayer

People needed

823

Starts

2013-06-12

Expected to finish

2014-08-07

Last updated by the study team

2021-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Chula Vista, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Flint, Michigan, United States
• Study site — Flushing, New York, United States
• Study site — Orangeburg, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — St Leonards, New South Wales, Australia
• Study site — Clayton, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Prahran, Victoria, Australia
• Study site — Reservoir, Victoria, Australia
• Study site — Box Hill, Australia
• Study site — Woolloongabba, Australia
• Study site — Graz, Austria
• Study site — Innsbruck, Austria
• Study site — Salzburg, Austria
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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