NCT01968668

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	BAY94-8862	1.25 mg BAY94-8862 tablet once daily in the morning
DRUG	BAY94-8862	2.5 mg BAY94-8862 tablet once daily in the morning
DRUG	BAY94-8862	5 mg BAY94-8862 tablet once daily in the morning
DRUG	BAY94-8862	7.5 mg BAY94-8862 tablet once daily in the morning
DRUG	BAY94-8862	10 mg BAY94-8862 tablet once daily in the morning
DRUG	Placebo	Placebo tablet once daily in the morning
DRUG	BAY 94-8862	15 mg BAY 94-8862 tablet once daily in the morning
DRUG	BAY 94-8862	20 mg BAY 94-8862 tablet once daily in the morning

Timeline

• Start date: 2013-10-28
• Primary completion: 2014-10-09
• Completion: 2014-11-07
• First posted: 2013-10-24
• Last updated: 2021-07-16

Locations

16 sites across 1 country: Japan