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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 365
- 主要终点
- Change from baseline in urinary albumin to creatine ratio (UACR)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CS-3150 1.25 mg
Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.
干预措施: CS-3150 (Drug)
CS-3150 0.625 mg
One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
干预措施: placebo (Drug)
CS-3150 0.625 mg
One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
干预措施: CS-3150 (Drug)
CS-3150 2.5 mg
One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
干预措施: CS-3150 (Drug)
CS-3150 2.5 mg
One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
干预措施: placebo (Drug)
CS-3150 5.0 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast
干预措施: CS-3150 (Drug)
Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in urinary albumin to creatine ratio (UACR)
时间窗: Baseline to end of Week 12
次要结局
- 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)