Status:
COMPLETED
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
Lead Sponsor:
Bayer
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2014
Estimated Enrollment :
823 Patients enrolled
Trial Details
Trial ID
NCT01874431
Start Date
June 12 2013
End Date
August 7 2014
Last Update
July 1 2021
Active Locations (147)
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1
Birmingham, Alabama, United States, 35294
2
Chula Vista, California, United States, 91910
3
Los Angeles, California, United States, 90022
4
Los Gatos, California, United States, 95032