NCT02317484已完成不适用
Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- HbA1c change level
研究概览
简要总结
The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs
- •Patients with changes within +- 0.5% of HbA1c
- •Patients with the variation of 6.5% =< HbA1C =<10%
- •Patients with written informed consents
- •Patients whose BMI is =>20kg/m2
排除标准
- •Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes
- •Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months
- •Patients with severe infection, in the perioperative period or severe trauma
- •Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL、female with greater than or equal to1.3mg/dL)
- •Patients with severe hepatic impairment (judged by the attending doctor)
- •Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent
- •Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy
- •Patients with neuropathic bladder or dysuria
- •Patients under treatment with diuretic
- •Patients under SGLT2 treatment at the kickoff point of the study
- •Patients with a history of hypersensitivity to SGLT2 inhibitors
- •Patients who are judged ineligible by the principal investigator
研究组 & 干预措施
Ipragliflozin (SGLT2 inhibitor)
干预措施: Ipragliflozin (SGLT2 inhibitor) (Drug)
结局指标
主要结局
HbA1c change level
时间窗: After 52 weeks from the time of treatment initiation
次要结局
- Sugar metabolism and body composition change levels(After 12, 24, 36, 52 weeks from the time of the start of treatment)
- HbA1c achievement rate(After 12, 24, 36, 52 weeks from the time of treatment initiation)
- Body composition and visceral fat change levels(After 24 and 52 weeks from the time of treatment initiation)
研究者
研究点 (1)
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