A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT2080222722
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 325
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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in urinary albumin to creatine ratio (UACR)
- Secondary Outcome Measures
Name Time Method Transition from microalbuminuria to normoalbuminuria<br>Change in renal function <br>Change in serum potassium