NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	16/01/2015
Target sample size	325
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome	Change from baseline in urinary albumin to creatine ratio (UACR)
Secondary Outcome	Transition from microalbuminuria to normoalbuminuria Change in renal function Change in serum potassium

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	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
Exclude criteria	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