Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function in Newly-diagnosed Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- the percentage of the patients who maintain glucose control 1 year after short intensive therapy
研究概览
简要总结
The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.
详细描述
The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.liraglutide combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed type 2 diabetes
- •fasting blood glucose (FBG) level ranging from 7.0-16.7mmol/L
- •body mass index (BMI) ranging from 21-35kg/m2
- •antihypercaemic and antihyperlipidemic medication-naive patients
排除标准
- •having any severe acute or chronic diabetic complications
- •renal dysfunction, blood creatinine>150umol/L
- •blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
- •any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
- •chronic or acute pancreatic disease
- •severe systemic diseases or malignant tumor
- •female patients incline to be pregnant
- •being treated with corticosteriod, immunosuppressing drugs or cytotoxic drugs
- •poor compliance
研究组 & 干预措施
CSII
continuous subcutaneous insulin infusion for 2-4 weeks
干预措施: CSII (Drug)
Liraglutide
continuous subcutaneous insulin infusion for 2-4 weeks combined with combined with Liraglutide 0.6mg/d for 2-4 weeks and 1.2mg/d for next 9 weeks
干预措施: CSII (Drug)
Liraglutide
continuous subcutaneous insulin infusion for 2-4 weeks combined with combined with Liraglutide 0.6mg/d for 2-4 weeks and 1.2mg/d for next 9 weeks
干预措施: Liraglutide (Drug)
结局指标
主要结局
the percentage of the patients who maintain glucose control 1 year after short intensive therapy
时间窗: 1 year
次要结局
- the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients(1 year)
- the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients(1 year)
研究者
Yanbing Li
director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University