Exploring Effective and Safety Therapies Which Protect Islet β Cell on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Fasting blood glucose,glycosylated hemoglobin(GHbA1c)
研究概览
简要总结
Prevalence of diabetes is increasing rapidly both in China and all over the world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."High glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further even β-cell function failure.It is urgent to explore more effective and safety treatments which can also protect islet cells function.How to release high glucose toxicity , reverse the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose toxicity and protecting islet β cell function compared with traditional treatments on newly diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic β-cell function.
详细描述
Patients were divided into 3 groups:
- DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose;
- insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin;
- Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly onset
- •type 2 diabetes
- •BMI 18-30kg/m2
- •FBS≧11.1mmol/L，GHbA1c≧9%
- •urine ket ≦(1+)
- •Normal liver and kidney function
排除标准
- •type 1 diabetes
- •renal or hepatic insufficiency
- •Severe ketoacidosis
- •Treatment with corticosteroids, immunosuppressive agents or cytotoxic drugs
- •Severe systemic disease
- •History of pancreatitis or pancreatic surgery
- •Pregnant and lactating women
研究组 & 干预措施
DPP4 group
DPP4 inhibitor,1 pill qd
干预措施: DPP4 (Drug)
insulin group
insulin,glargine or detemir，0.2U/Kg,qd
干预措施: Insulin (Drug)
SU group
SU,Glimepiride，1-2mg qd
干预措施: SU (Drug)
结局指标
主要结局
Fasting blood glucose,glycosylated hemoglobin(GHbA1c)
时间窗: From date of randomization until the date of first documented progression, assessed up to 3 months
mmol/L,%
次要结局
- Lipid changes(From date of randomization until the date of first documented progression, assessed up to 3 months)
- weight loss(From date of randomization until the date of first documented progression, assessed up to 3 months)
- Incidence of hypoglycemia(From date of randomization until the date of first documented progression, assessed up to 3 months)