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临床试验/NCT00348231
NCT00348231Unknown不适用

Jikei Optimal Insulin Therapy in Type 2 Diabetes

Jikei University School of Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
HbA1c

研究概览

简要总结

The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.

详细描述

The current insulin therapy is divided into the conventional insulin therapy (1~2 injections per day) and the intensive insulin therapy (3~4 injections per day). The kinetics of exogenous insulin in the intensive insulin therapy imitate the kinetics of insulin secretion in a healthy person. A previous large clinical study (e.g. DCCT, Kumamoto study, etc.) suggested that intensive insulin therapy prevented microangiopathy and macroangiopathy, and inhibited progression of them, however many patients chose conventional insulin therapy because many hoped that they injected insulin as few as possible. The patients thought that their life styles were disturbed by many times of insulin injection.

The current dual-acting insulin made from insulin as part modified by protamine is able to suppress postprandial hyperglycemia. The new insulin may possibly have the kinetics of insulin in the patient who uses insulin as the intensive insulin therapy. Moreover, the patients will receive the insulin therapy easily if the times of insulin injection are fewer. It may lead to perform the more effective insulin therapy to search for the optimal insulin therapy in induction in type 2 diabetes.

comparison:HbA1c, glycated albumin, IMT, lipid profile,body weight, daily profile of blood glucose,between the conventional insulin therapy and the intensive insulin 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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Type 2 diabetes
  • secondary failure of SU drug
  • whose age is to 80 from 20 years old

排除标准

  • who has the complication
  • who has a allergy of insulin
  • who is pregnant

结局指标

主要结局

HbA1c

daily profile of blood glucose

次要结局

  • IMT
  • QOL

研究者

申办方类型
Other

研究点 (2)

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