This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design. Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
1.25 mg BAY94-8862 tablet once daily in the morning
2.5 mg BAY94-8862 tablet once daily in the morning
5 mg BAY94-8862 tablet once daily in the morning
7.5 mg BAY94-8862 tablet once daily in the morning
10 mg BAY94-8862 tablet once daily in the morning
Placebo tablet once daily in the morning
15 mg BAY 94-8862 tablet once daily in the morning
20 mg BAY 94-8862 tablet once daily in the morning
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Saijō, Ehime, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Obihiro, Hokkaido, Japan
Unnamed facility
Amagasaki, Hyōgo, Japan
Unnamed facility
Koga, Ibaraki, Japan
Unnamed facility
Tsuchiura, Ibaraki, Japan
Unnamed facility
Tsukuba, Ibaraki, Japan
...and 6 more locations
Change of urinary albumin-to creatinine ratio
Time frame: Baseline and 90 days
Change in serum potassium concentration
Time frame: Baseline and 90 days
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