NCT03631121Unknown4 期
Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of glycemic variation
研究概览
简要总结
The study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with Basalin and one week after changing the insulin into Lantus.
详细描述
The participants will take continuous glucose monitoring system for 3 days when they change the insulin into Lantus after reach euglycemia control with Basalin treatment for one week.
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 Basalin with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 3 month would be recruited into this study;
- •Patients had relatively constant diet and exercise in 2 month before the study.
- •Fasting blood glucose<6.1mmol/L, and postprandial (or random) blood glucose <14mmol/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;
- •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
Basalin to Lantus
Experimental
the patients who are using Basalin treatment will use isodose of Lantus instead
干预措施: Basalin to Lantus (Drug)
结局指标
主要结局
Change of glycemic variation
时间窗: Day 1-13
The changes of glycemic variation before and after drug change
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other TreatmentDiabetes MellitusNCT00046462Sanofi240
已完成
不适用
Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 DiabetesType 2 DiabetesNCT04374578Shanghai Zhongshan Hospital100
Unknown
不适用
Relationship Between Blood Glucose Variability and Prognosis in Critically Ill PatientsDiabetesNCT03629704Nanjing First Hospital, Nanjing Medical University200
已完成
4 期
Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)Type 2 Diabetes MellitusNCT00562172Sanofi75
已完成
不适用
Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic SubjectsDiabetesNCT02673203Yale University31