Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
NCT02545049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7352
Last updated 2022-04-15
Summary
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
Conditions
- Diabetic Kidney Disease
Interventions
- DRUG
-
Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
- DRUG
-
Matching placebo to be taken orally, once daily.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-17
- Primary Completion
- 2021-02-02
- Completion
- 2021-02-02
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hong Kong
- Hungary
- Ireland
- Israel
- Italy
- Japan
- Lithuania
- Malaysia
- Mexico
- Netherlands
- New Zealand
- Norway
- Philippines
- Poland
- Portugal
- Puerto Rico
- Romania
- Russia
- Singapore
- Slovakia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
- Vietnam
Study Locations
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