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

Study Overview
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Brief Summary
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This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria. The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Type 2 Diabetes Mellitus and Microalbuminuria

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: CS-3150
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with type 2 diabetes mellitus Male or female subjects aged 20 years or older at informed consent Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and < 300 mg/g Cr Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m^2 Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period Exclusion Criteria: Type 1 diabetes HbA1c (NGSP) >=8.4% Secondary glucose intolerance Subjects diagnosed with non-diabetic nephropathy Nephrotic syndrome Secondary hypertension or malignant hypertension Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 4.8 mEq/L

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-3150 0.625 mg<br>One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast. | Drug: CS-3150<br> <br> Drug: placebo<br> <br> |
| Experimental: CS-3150 1.25 mg<br>Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast. | Drug: CS-3150<br> <br> |
| Experimental: CS-3150 2.5 mg<br>One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast. | Drug: CS-3150<br> <br> Drug: placebo<br> <br> |
| Experimental: CS-3150 5.0 mg<br>Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast | Drug: CS-3150<br> <br> |
| Placebo Comparator: Placebo<br>Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urinary albumin to creatine ratio (UACR) |  | Baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition from microalbuminuria to normoalbuminuria |  | Baseline to end of Week 12 | 
| Change in renal function |  | Baseline to end of Week 12 | 
| Change in serum potassium |  | Baseline to end of Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Nephropathy, mineralocorticoid receptor antagonist, CS-3150, Japanese