A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
Diabetic Nephropathy
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy, mineralocorticoid receptor antagonist, CS-3150, Japanese
Eligibility Criteria
Inclusion Criteria:
- Subjects with type 2 diabetes mellitus
- Male or female subjects aged 20 years or older at informed consent
- Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and < 300 mg/g Cr
- Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m^2
- Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period
Exclusion Criteria:
- Type 1 diabetes
- HbA1c (NGSP) >=8.4%
- Secondary glucose intolerance
- Subjects diagnosed with non-diabetic nephropathy
- Nephrotic syndrome
- Secondary hypertension or malignant hypertension
- Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 4.8 mEq/L
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
CS-3150 0.625 mg
CS-3150 1.25 mg
CS-3150 2.5 mg
CS-3150 5.0 mg
Placebo
One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.
One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.