NCT02791035已完成4 期
Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation between change of HbA1c and urinary glucose excretion
研究概览
简要总结
The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who has written informed consent
- •Subjects who are diagnosed as type 2 diabetes mellitus
- •Subjects who are 20 to 70 years old
- •Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
- •Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)
排除标准
- •Type 1 DM
- •Gestational DM
- •Diabetic ketoacidosis
- •CKD stage 3B-5 (eGFR 45)
- •Severe infection, serious trauma, or perioperative period
- •Known or suspected hypersensitivity to ipragliflozin
- •Symptomatic urogenital infection
- •Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
- •Under the therapeutic intervention and/or another clinical study using IP drug
- •Hepatic disease ( 3 times of upper normal limit of AST or ALT)
- •Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia
- •Drugs not allowed for concomitant use
- •Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
- •Insulin within 60 days prior to screening
- •Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening
- •Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate
- •GLP-1 agonist (except for exenatide) within 60 days prior to screening
- •Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening
- •Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening
- •Subjects who are not eligible to the study according to an investigator's decision
- •Inability to read the consent form
- •Pregnancy, lactation, or plan to get pregnant during the study period
研究组 & 干预措施
Ipragliflozin
Experimental
Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks
干预措施: Oral administration of Ipragliflozin (Drug)
结局指标
主要结局
Correlation between change of HbA1c and urinary glucose excretion
时间窗: Baseline and week 12
次要结局
- Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)(Baseline and week 12)
- Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)(Baseline and week 12)
- Change of HbA1c(Baseline and week 12)
- Chang e of fasting glucose(Baseline and week 12)
- Change of waist circumference(Baseline and week 12)
- Percentage of subjects achieving the target HbA1c(<6.5%)(week 12)
研究者
WOO JE LEE
Associate Professor
Asan Medical Center
研究点 (1)
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