Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- the effect of dapagliflozin combined with CSII on glucose profile
研究概览
简要总结
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
详细描述
To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •volunteer to participate and be able to sign informed consent prior to the trial.
- •patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
- •No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- •Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
排除标准
- •Patients with insulin allergy.
- •Impaired liver and kidney function with 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.
- •Drug abuse and alcohol dependence in the past 5 years.
- •Systemic hormone therapy was used in the last three months.
- •Patients with poor compliance and irregular diet and exercise.
- •Patients with pregnancy, lactation or pregnancy intention.
- •Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
研究组 & 干预措施
Dapagliflozin combined with CSII
Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.
干预措施: Dapagliflozin 10 MG (Drug)
CSII alone
Aspart infused by CSII alone as glucose lowering therapy.
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
the effect of dapagliflozin combined with CSII on glucose profile
时间窗: 5 weeks
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile(the mean amplitude of glycemic excursions(MAGE),The 24-hrs mean glucose(MG) ) in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system
次要结局
- the effects of dapagliflozin combined with CSII on blood pressure(5 weeks)
- the effects of dapagliflozin combined with CSII on weight(5 weeks)
- the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)(5 weeks)