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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bayer
Study ID
NCT01874431
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Nephropathies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 12, 2013
Status verified
Jun 2021
Primary completion
Jul 9, 2014
Completion
Aug 7, 2014

Study Design

Enrollment
823 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone (BAY94-8862) (1.25 mg)
    1.25 mg dose oral once daily for 90 days
  • Experimental: Finerenone (BAY94-8862)(2.5 mg)
    2.5 mg dose oral once daily for 90 days
  • Experimental: Finerenone (BAY94-8862)(5 mg)
    5 mg dose oral once daily for 90 days
  • Experimental: Finerenone (BAY94-8862)(7.5 mg)
    7.5 mg dose oral once daily for 90 days
  • Experimental: Finerenone (BAY94-8862) (10 mg)
    10 mg dose oral once daily for 90 days
  • Experimental: Finerenone (BAY94-8862) (15 mg)
    15 mg dose oral once daily for 90 days
  • Experimental: Finerenone (BAY94-8862)(20 mg)
    20 mg dose oral once daily for 90 days
  • Placebo Comparator: Placebo
    Placebo oral dose once daily for 90 days

Primary Outcome Measure

Ratio of UACR at Day 90 to UACR at Baseline [ Time Frame: Baseline and Day 90±2 ]

Locations (15)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35294-
-Chula VistaCalifornia91910-
-Los AngelesCalifornia90022-
-Los GatosCalifornia95032-
-New HavenConnecticut06510-
-MiamiFlorida33015-
-Pembroke PinesFlorida33028-
-ChicagoIllinois60611-
-ChicagoIllinois60612-
-FlintMichigan48504-
-FlushingNew York11355-
-OrangeburgSouth Carolina29118-
-ChattanoogaTennessee37408-
-DallasTexas75235-3858-
-BurlingtonVermont05401-

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