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A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria

A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222722
Enrollment
325
Registered
2015-01-16
Start date
2015-01-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

investigational material(s) Generic name etc : CS-3150 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : E

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 = 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

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 = 5.1 mEq/L; For subjects with eGFRcreat of >= 30 mL/min/1.73 m2 and = 4.8 mEq/L

Design outcomes

Primary

MeasureTime frame
Change from baseline in urinary albumin to creatine ratio (UACR)

Secondary

MeasureTime frame
Transition from microalbuminuria to normoalbuminuria Change in renal function Change in serum potassium

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026