Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- remission rate
研究概览
简要总结
Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week;
- •GHbA1c ≥ 9%
- •Body mass index between 20-35kg/m2
- •Capable to use wearable devices and mobile Apps;
- •willling to follow the study protocol and data collection.
排除标准
- •Type 1 diabetes or specific types of diabetes;
- •Allergic or intolercance to medicine used in the study;
- •Acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
- •Severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy;
- •Glomerular filtration rate less than 50 ml/min
- •ALT >2.5 times of the upper limit of normal (ULN), or bilirubin > 1.5 times of ULN；
- •Significant Macrovascular disease:acute cerebrovascular accident, acute coronary syndrome or peripheral artery disease that required vascular intervention or amputation 12 months before enrollment;
- •Poor blood pressure control (systolic blood pressure≥180mmHg and/or sitting diastolic blood pressure ≥110mmHg) and unable to control under 160/110mmhg within 1 week;
- •Hemoglubin level < 100g/L or required regular blood transfusion;
- •Chronic cardiac dysfunction with NYHA grade III or above;
- •Use of medicines that affect blood glucose for a cumulative time of more than 1 week within the prior 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic replacement of thyroid hormone are allowed;
- •Serious systemic disease or malignant tumor, chronic diarrhea, etc；
- •Uncontrolled abnormalty in endocrine glands (Cushing's syndrome, hyperthyroidism, etc.);
- •Any factors that may affect the participation of the subject in the study or the evaluation of the results；
- •Pregnancy or planned pregnancy, lactation subjects.
研究组 & 干预措施
Simplified regimen group
Short-term continuous subcutaneous insulin infusion will be adminstrated to maintained euglycemia for 1 week，Then subsequent therapy using basal insulin plus metformin will be administrated. After withdrawal of the medicine, wearable devices and smart apps will be used for long-term management.
干预措施: Simplified intensive insulin therapy regimen (Drug)
Routine group
Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely.
干预措施: Traditional Short-term Intensive insulin therapy (Drug)
结局指标
主要结局
remission rate
时间窗: 24 weeks after withdrawal of the medical intervention
Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents
次要结局
未报告次要终点
研究者
Yanbing Li
Professor
Sun Yat-sen University