NCT03631134Unknown4 期
Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Changes of glycemic variation
研究概览
简要总结
The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
- •Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
- •Patients had relatively constant diet and exercise in 2 month before the study.
- •Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L
排除标准
- •Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
- •Patients with severe infectious diseases;
- •Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
- •Patients with history of psychiatric disorders and were unsuitable to use CGMS;
- •Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months
- •Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
研究组 & 干预措施
SGLT2i treatment
Experimental
The patients who are using basal insulin therapy with or without oral hypoglycemic drugs will be added SGLT2 inhibitor treatment
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Changes of glycemic variation
时间窗: Week 1-5
Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding
次要结局
- Change of insulin dose(Week 1-5)
研究者
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