This is a multi-center, placebo-controlled, randomized, 5-parallel group, double-blind study.
2
1) Subject with type 2 diabetes mellitus
2) Male or female subjects aged 20 years or older at informed consent
3) Subject with urinary albumin to creatine ratio (UACR) >= 45 mg/g Cr and < 300 mg/g Cr
4) Estimated glomerular filtration rate by creatinine (eGFRcreat) >= 30 mL/min/1.73 m2
5) Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for more than 3 months prior to treatment period
Type-1 diabetics
2) HbA1c (NGSP) >=8.4%
3) Secondary glucose intolerance
4) Subjects diagnosed with non-diabetic nephropathy
5) Nephrotic syndrome
6) Secondary hypertension or malignant hypertension
Serum potassium level in any of the following categories: For subjects with eGFRcreat of >= 45 mL/min/1.73 m2, serum potassium level of < 3.5 mEq/L or >= 5.1 mEq/L; For subjects with eGFRcreat of >= 30 mL/min/1.73 m2 and < 45 mL/min/1.73 m2, serum potassium level of < 3.5 mEq/L or >= 4.8 mEq/L
20age old over
No limit
Both
Type 2 Diabetes Mellitus
investigational material(s)
Generic name etc : CS-3150
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : Each subject will orally take the assigned study drug once daily after breakfast for 12 weeks.
Change from baseline in urinary albumin to creatine ratio (UACR)
Transition from microalbuminuria to normoalbuminuria
Change in renal function
Change in serum potassium
