Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urine albumin-to-creatinine ratio (UACR)
研究概览
简要总结
This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).
详细描述
Eligible participants will be randomly assigned (1:1) to tofogliflozin or metformin with stratification based on UACR (<300 mg/gCr，≧300mg/gCr), an estimated glomerular filtration rate (eGFR) (<60mL/min/1.73m2, ≧60 mL/min/1.73m2), and age (<65 years old, ≧65 years old). The primary end point is change in urine albumin-to-creatinine ratio (UACR) from baseline after 52 weeks treatment. Changes in eGFR, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, uric acid, hematocrit, hemoglobin, red blood cell count, pulse rate, triglyceride, low-density lipoprotein, high-density lipoprotein and albuminuria class transition rate will also be evaluated.
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
- None
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
- •Type 2 diabetic patients
- •Patients aged 20 years or older at the time of obtaining consent
- •Patients with HbA1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor / metformin)
- •Patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug.
- •Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer
- •Patients with eGFR of 30 or more (mL / min / 1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor / metformin)
- •Patients with urinary albumin / creatinine ratio (UACR) of 30 or more and less than 2000 (mg / gCr) (4 weeks or more without taking SGLT2 inhibitor / metformin) within 13 weeks before obtaining consent Evaluate by inspection value)
- •Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study
排除标准
- •Patients receiving treatment with SGLT2 inhibitor or metformin within 13 weeks before obtaining consent
- •Dialysis patient
- •Patients with a history of severe hypoglycemia
- •Patients with hypersensitivity to SGLT2 inhibitor or metformin
- •Pregnant women, lactating patients, and patients who wish to raise children
- •Patients with BMI of 35 kg / m2 or more based on the latest measured values within 13 weeks before obtaining consent
- •Patients who are contraindicated for the study drug
- •Other patients who the attending physician deems inappropriate as a subject
研究组 & 干预措施
Tofogliflozin
干预措施: Tofogliflozin (Drug)
Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Urine albumin-to-creatinine ratio (UACR)
时间窗: Up to 52 weeks
Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment.
次要结局
- Change slope in eGFR(Up to 52 and 104 weeks)
- Total serum proteins(Up to 52 and 104 weeks)
- Serum albumin(Up to 52 and 104 weeks)
- HbA1c(Up to 52 and 104 weeks)
- Body weight(Up to 52 and 104 weeks)
- Systolic / diastolic blood pressure(Up to 52 and 104 weeks)
- Uric acid(Up to 52 and 104 weeks)
- Urine albumin-to-creatinine ratio (UACR)(Up to 26, 52 and 104 weeks)
- Hematocrit(Up to 52 and 104 weeks)
- Hemoglobin(Up to 52 and 104 weeks)
- Red blood cell count(Up to 52 and 104 weeks)
- Pulse rate(Up to 52 and 104 weeks)
- Triglyceride(Up to 52 and 104 weeks)
- Low-density lipoprotein(Up to 52 and 104 weeks)
- High-density lipoprotein(Up to 52 and 104 weeks)
- Albuminuria class(Up to 104 weeks)
研究者
Koichiro Kuwahara
MD, PhD, Professor
Shinshu University