跳至主要内容
临床试验/NCT02129985
NCT02129985Unknown4 期

Effect of Short-term Intensive Insulin Sequential Exenatide Therapy on Beta Cell Function and Glycaemic Control in Patients With Newly Diagnosed Type 2 Diabetes :a Multicenter Prospective Randomized Control Study

xiaolong zhao1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
time to glycaemic remission

研究概览

简要总结

Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

详细描述

The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus,irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.Short-term intensive insulin therapy of newly diagnosed type 2 diabetes has been proved improving beta-cell function and usually leading to a temporary remission time,but the remission rate in a year is only about 50%. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is an GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. Our hypotheses is whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed type 2 diabetes without drug treatment
  • 25-70 years old age
  • Fasting glucose between 7.0-16.7mmol / L
  • BMI at 20 ~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
  • females who have no plan of pregnancy during the study

排除标准

  • acute or chronic complications of diabetes
  • myocardial infarction or cerebrovascular events within three months
  • serious gastrointestinal diseases
  • other serious concomitant diseases
  • liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
  • GAD antibodies positive
  • history of pancreatitis or pancreatic cancer;
  • pregnant or breastfeeding women.
  • severe hypertension (blood pressure> 180/110mmhg)
  • using corticosteroids, immunosuppressants and cytotoxic therapy.

研究组 & 干预措施

Exenatide

Experimental

patients were all received a short-term intensive insulin therapy,then randomised to Exenatide group(10 ug two times a day for three months)

干预措施: Exenatide (Drug)

Metformin

Active Comparator

patients were all received a short-term intensive insulin therapy,then randomised to metformin group(850mg two times a day for three months)

干预措施: Metformin (Drug)

结局指标

主要结局

time to glycaemic remission

时间窗: up to 1 year

time of glycaemic remission at 1 year after exenatide sequential therapy followed by a short-term insulin intensive treatment

remission rate of type 2 diabetes at a year.

时间窗: up to 1 year

remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy

次要结局

  • the beta cell function change(1 year)

研究者

发起方
xiaolong zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

xiaolong zhao

Endocrinology department

Huashan Hospital

研究点 (1)

Loading locations...

相似试验