Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
研究概览
简要总结
The Multi-center, randomized, controlled clinical trial investigate the efficacy and safety of Henagliflozin combined with continuous subcutaneous insulin infusion in newly diagnosed type 2 diabetes
详细描述
The therapeutic mechanisms of Sglt2i and continuous subcutaneous insulin infusion (CSII) are complementary. We hypothesized that for newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia, combination treatment with Henagliflozin and CSII could achieve glycaemic control in a shorter time, shorten the duration of hospitalization and reduce the total insulin dosage. We also hope to investigate the safety of sglt2i in combination with CSII in T2DM based on 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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years
- •Age between 20 and 70 years
- •Continuous use of any hypoglycemic drug ≤ 7 days within 6 months
- •9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L
- •Body mass index (BMI) of between 20 and 32 kg/m2
- •Be able to understand the contents and methods of this study and sign the informed consent form voluntarily
排除标准
- •Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications
- •Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history
- •Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control
- •People with negligent compensatory heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, serious arrhythmia, cardiac surgery or vascular reconstruction within 6 months
- •Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)
- •Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery)
- •Uncontrolled hyperthyroidism
- •Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate
- •Pregnant or lactating women
- •ALT>3.0x ULN and/or AST>3.0x ULN and/or Tbil>2.0x ULN Blood ketone body>ULN eGFR<30ml/min/1.73 m2 Blood creatine kinase>3.0x ULN
研究组 & 干预措施
Henagliflozin+ Continuous Subcutaneous Insulin Infusion
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
干预措施: Henagliflozin (Drug)
Henagliflozin+ Continuous Subcutaneous Insulin Infusion
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
干预措施: Continuous Subcutaneous Insulin Infusion (Device)
Continuous Subcutaneous Insulin Infusion
Continuous Subcutaneous Insulin Infusion therapy alone
干预措施: Continuous Subcutaneous Insulin Infusion (Device)
结局指标
主要结局
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
时间窗: Monitoring 5-14 days
Compare the TIR of the two treatment groups
次要结局
- Mean Amplitude of Glycemic Excursions (MAGE)(5-14 days after treatment)
- Time taken for TIR >70%(5-14 days after treatment)
- time below range (TBR)(5-14 days after treatment)
- total insulin dosage(5-14 days after treatment)
- time above range (TAR)(5-14 days after treatment)