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Clinical Trials/JPRN-jRCT2080222722
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

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.

Registry
who.int
Start Date
January 16, 2015
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
DAIICHISANKYO Co.,Ltd.

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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