NCT01610154已完成4 期
Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
Guangwei Li1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
- The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.
- There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight (BMI>25) Chinese type 2 diabetics.
- The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25~60 years
- •Duration of disease < 3 years,no drug treatment for diabetes
- •Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)
- •Fasting plasma glucose < 10 mmol/L
排除标准
- •Type 1 diabetes
- •DKA, infection and other stress status
- •Autoimmune disease
- •Hepatic and renal diseases
研究组 & 干预措施
Sitagliptin treatment
Experimental
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline to 12 weeks
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline to 12 weeks)
- Change From Baseline in Postprandial Plasma Glucose (PPG)(Baseline to 12 weeks)
- Change From Baseline in Insulin Sensitivity(Baseline to 12 weeks)
- Change From Baseline in Insulin Sensitivity in Patients With Different BMI(Baseline to 12 weeks)
- Change From Baseline in Pancreatic β Cell Function(Baseline to 12 weeks)
- Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI(Baseline to 12 weeks)
- Change From Baseline in Pancreatic α Cell Function(Baseline to 12 weeks)
- Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI(Baseline to 12 weeks)
研究者
Guangwei Li
director of endocrinology and cardiovascular disease center of Fuwai hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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