JPRN-jRCTs031180434已完成未知
Multicenter explorative study of the beneficial effect of Luseogliflozin on cardiovascular function in Japanese T2DM patients (LUSCAR Study)
Kario Kazuomi0 个研究点目标入组 48 人开始时间: 2019年3月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
This study investigated the effects of the SGLT2 inhibitor, luseogliflozin, on arterial properties and home blood pressure (BP) in patients with T2DM. This was a multicenter, single-arm study. Luseogliflozin 2.5 mg/day was given for 12 weeks. In conclusion, there was no change in arterial stiffness based on CAVI in the study period; however, changes in BP and metabolic parameters were consistent with the documented beneficial effects of SGLT2 inhibitors in T2DM.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •(1) Type 2 diabetes mellitus (no medication or using a diabetic medicine)
- •(2) HbA1c 6.5-9.0% within 4 weeks before registration
- •(3) Patients who are planned or considered to take or add a diabetes medication by the physicians
- •(4) Possible to take Luseogliflozin
- •(5) 20-74 years old
- •(6) Written informed consent
排除标准
- •(1) T1 diabetes mellitus
- •(2)Using SGLT2 inhibitors
- •(3) Using insulin
- •(4) Using GLP-1 receptor agonist
- •(5) Patients who have been changed medications for hypertension or hyperglycemia for recent 12 weeks
- •(6)History of serious sensitivity of SGLT2 inhibitors
- •(7) History of cerebral infraction
- •(8)Severe renal dysfunction (eGFR<30ml/min/1.73m2) or under going dialysis
- •(9) Severe liver dysfunction
- •(10)Pituitary dysfunction or adrenal insufficiency
- •(11)Pregnant, possibly pregnant or breast feeding
- •(12) Participants of other clinical studies except observational studies
- •(13) The physicians consider that the patients are inappropriate for this study
研究者
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