Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 主要终点
- proportions of 1 year remission of type 2 diabetes
研究概览
简要总结
The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin 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
- 25 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 7.0～16.7 mmol/L
- •body mass index (BMI) ranging from21～35kg/m2
- •Antihyperglycaemic and antihyperlipidemic medication-naive patients
排除标准
- •having any severe acute or chronic diabetic complications
- •renal dysfunction, blood creatinine≥150µmol/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 systematic diseases or malignant tumor
- •female patients incline to be pregnant
- •being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- •poor compliance
研究组 & 干预措施
CSII
continuous subcutaneous insulin infusion
干预措施: CSII (Drug)
Metformin & Pioglitazone
CSII combined with metformin and pioglitazone
干预措施: CSII, Metformin, Pioglitazone (Drug)
Sitagliptin
CSII combined with sitagliptin 100mg/d
干预措施: CSII, Sitagliptin (Drug)
结局指标
主要结局
proportions of 1 year remission of type 2 diabetes
时间窗: 1 years
the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients
次要结局
- the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients(1 years)
研究者
Yanbing Li
the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University