JPRN-jRCT2080222722
Unknown
Phase 2
A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
DAIICHISANKYO Co.,Ltd.0 sites325 target enrollmentJanuary 16, 2015
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- DAIICHISANKYO Co.,Ltd.
- Enrollment
- 325
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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/
Outcomes
Primary Outcomes
Not specified
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