JPRN-jRCTs071180041已完成4 期
Prevention of atherosclerosis by SGLT2inhibitor: a multicenter, randomized controlled study - PROTECT
ode Koichi0 个研究点目标入组 482 人开始时间: 2019年3月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 482
研究概览
简要总结
A total of 482 subjects were equally randomized to the ipragliflozin and control groups. Changes of the mean CCA-IMT for 24 months, which was the primary endpoint, was 0.0013 mm in the ipragliflozin group, and 0.0015 mm in the control group, and the estimated between-group difference(ipragliflozin group-control group) was -0.0001mm (P=0.989). These results suggest that 24-month treatment of ipragliflozin, compared to conventional therapy, in patients with type 2 diabetes had no impact on the CCA-IMT.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and less than10.0% despite diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for over three months
- •2)over 20 years of age at the time of informed consent acquisition and hospitalization or outpatient
- •3) The patient provided with information about the study,submitted written informed consent to it
排除标准
- •1) Type 1 diabetes
- •2) Has history of severe ketosis, diabetic coma, or precoma within 6 months
- •3) Has severe infection, serious trauma, or pre or post surgery (including carotid endarterectomy and stent implantation)
- •4) With severe renal dysfunction (eGRF <45 mL/min/1.73m2 or patient undergoing artificial dialysis)
- •5) Has history of myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage and transient ischemic attacks within 3 months before initiation of the study
- •6) Heart failure patient whose NYHA functional classification is III or IV
- •7) Has history of administration of SGLT-2 within 1 month before initiation of the study
- •8) Pregnant, possibly pregnant, planned to become pregnant or nursing women
- •9) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
- •10) Are considered not eligible for the study by the attending doctor due to other reasons
研究者
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Prevention of atherosclerosis by SGLT2 inhibitor; multicenter, randomized controlled studyType 2 diabetesJPRN-UMIN000018440Department of Cardiovascular Medicine, Saga University479
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