The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Insulin autoimmune antibody
研究概览
简要总结
Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes;
- •Treated with premix insulin, two or three injections a day, single drug or combination of oral hypoglycemic drugs;
- •The treatment regimen was stable for more than 2 months;
- •With positive insulin antibody
排除标准
- •Patients treated with GLP-1 agonist in the last 3 months;
- •Allergic to insulin;
- •Impaired liver and renal function (ALT 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal);
- •A history of drug abuse and alcohol dependence;
- •Used systemic glucocorticoids therapy in recent 3 months;
- •Patients with infection or stress within four weeks;
- •Patients who cannot tolerate FGM;
- •Pregnant or preparing to become pregnant;
- •Considered unsuitable to participate by the investigator.
研究组 & 干预措施
Oral hyppoglycemia drug group
Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.
干预措施: Add oral hyppoglycemia drug (Other)
GLP-1RA group
Add GLP-1 receptor agonists to reduce insulin dose.
干预措施: Add GLP-1 receptor agonist (Other)
long-acting insulin group
Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs
干预措施: Change insulin (Other)
Control group
continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control.
结局指标
主要结局
Insulin autoimmune antibody
时间窗: 3 month
The change of insulin autoimmune antibody
次要结局
- Time in range(3 month)
- Time below range(3 month)
- B cell(3 month)
- HbA1c(3 month)
- T cell(3 month)