JPRN-jRCTs011180019已完成4 期
Study for the effect on blood pressure and heart rate fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor Luseogliflozin in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study - - Luseo-ABPM study
Cho Kyuyong0 个研究点目标入组 68 人开始时间: 2019年3月19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
- 68
研究概览
简要总结
In type 2 diabetic patients with hypertension, switching from the DPP-4 inhibitor to the SGLT2 inhibitor luseogliflozin resulted in a decrease in systolic blood pressure and pulse rate in nighttime and the improvement in blood pressure circarian rhythm. It was suggested that these improvements may be involved in reducing cardiovascular events caused by SGLT2 inhibitors.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1) HbA1c 6.0-9.0%.
- •2) Patients with type 2 diabetes who have been taking DPP-4 inhibitors (except weekly agents) for 4 weeks.
- •3) Patients with hypertension (>130/80 mmHg).
- •4) Written informed consent.
排除标准
- •1) Patients with taking SGLT2 inhibitors.
- •2) Hypersensitivity to Luseogliflozin.
- •3) Uncontrolled diabetic retinopathy
- •4) Severe liver dysfunction, renal dysfunction, or heart failure
- •5) Pregnancy, nursing woman or possibly pregnant woman
- •6) Severe diabetic ketosis, diabetic coma
- •7) Severe infection, pre and post operation
- •, severe trauma
- •8) Deficiency of insulin secretion
- •9) BMI < 22kg/m2
- •10) eGFR < 30 ml/min
- •11) Patients with uncontrolled diet therapy.
- •12) Patients with irregular circadian rhythm.
- •13) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
研究者
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