Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Conditions

• Diabetic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Finerenone (BAY94-8862) — DRUG
  10 mg or 20 mg Finerenone tablet to be given orally, once daily.
• Placebo — DRUG
  Matching placebo to be taken orally, once daily.

Study Details

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.

Key Dates

Start date

Sep 17, 2015

Status verified

Apr 2022

Primary completion

Feb 2, 2021

Completion

Feb 2, 2021

Study Design

Enrollment

7,352 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BAY94-8862
  Finerenone tablet
• Placebo Comparator: Placebo
  Matching placebo

Primary Outcome Measure

The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. [ Time Frame: From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. ]

Locations (173)

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