Phase 2
N=823
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
Diabetic Nephropathies
Bottom Line
View on ClinicalTrials.gov: NCT01874431 ↗Enrolled (actual)
823
Serious AEs
4.6%
Results posted
May 2021
Primary outcome: Primary: Ratio of UACR at Day 90 to UACR at Baseline — 0.869; 0.89; 0.824; 0.739 Ratio — p=0.1973
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Finerenone (BAY94-8862) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of UACR at Day 90 to UACR at Baseline |
0.869; 0.89; 0.824; 0.739; 0.708; 0.63 | 0.1973 |
| SECONDARY Change From Baseline to Day 90 in Serum Potassium |
0.109; 0.123; 0.202; 0.127; 0.167; 0.238 | 0.0428 sig |
| SECONDARY Change From Baseline to Day 90 in eGFR |
-2.364; -3.189; -2.497; -3.378; -4.192; -3.806 | 0.5454 |
| SECONDARY Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) |
-2.116; 0.104; -1.229; -1.185; -2.596; 0.112 | 0.0757 |
| SECONDARY Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) |
1.381; 3.888; 3.124; 2.851; 2.698; 2.743 | 0.0816 |
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.
Eligibility 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 /=30 mg/g but /=3.4mg/mmol but /=30 mL/min/1.73 m² but 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
Data sourced from ClinicalTrials.gov (NCT01874431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.