A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
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.
Inclusion Criteria:
Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria
Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:
Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit
Exclusion Criteria:
Monza-Brianza, Lombardy 20832, Italy
Klipsruit West, Gauteng 1812, South Africa
Lenasia South, Gauteng 1829, South Africa