Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin levels
研究概览
简要总结
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage < 30IU);
- •The anti-diabetic therapy is stable within 3 months before study screening;
- •Age: 25-65years, both gender, BMI: 20-35kg/m2;
- •Good compliance with the follow-up
- •Signed informed consent
- •HbA1c ≥ 8.0 % and ≤ 12%
排除标准
- •Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
- •For once daily insulin therapy: daily dose insulin therapy dosage > 30IU
- •Having the history of using GLP-1 for therapy within 3 months before screening
- •Women in pregnancy or under breast feeding
- •Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
- •Allergic to study drugs
- •Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
- •Other severe conditions which will put the patients in high risk during the study
- •Recently drug or alcohol abuse
研究组 & 干预措施
Continuous Subcutaneous Insulin Infusion
CSII
干预措施: Transient Continuous Subcutaneous Insulin Infusion (Drug)
Multiple Daily Insulin Injections
MDI
干预措施: Transient Multiple Daily Insulin Injections (Drug)
结局指标
主要结局
Glycated hemoglobin levels
时间窗: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Glycated albumin levels
时间窗: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
次要结局
- Biochemical parameters and inflammatory factors(During 2 weeks intensive treatment and 1 year after treatment)
- Body weight(During 2 weeks intensive treatment and 1 year after treatment)
- C peptide levels(During 2 weeks intensive treatment and 1 year after treatment)
- Number of participants with adverse events(During 2 weeks intensive treatment and 1 year after treatment)
- The glucose levels(During 2 weeks intensive treatment and 1 year after treatment)
- Episode of hypoglycemia(During 2 weeks of intensive treatment and 1 year after treatment)
研究者
Guang Ning
Professor
Shanghai Jiao Tong University School of Medicine