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

NCT01874431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 823

Last updated 2021-07-01

Study results available
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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.

Conditions

  • Diabetic Nephropathies

Interventions

DRUG

Finerenone (BAY94-8862)

DRUG

Placebo

Sponsors & Collaborators

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
2013-06-12
Primary Completion
2014-07-09
Completion
2014-08-07

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874431 on ClinicalTrials.gov