跳至主要内容
临床试验/NCT00474838
NCT00474838已完成4 期

The Effect of Intensive and Short-term Insulin Treatment on Long-term Pancreatic β-cell Function in Newly Diagnosed People With Type 2 Diabetes in Korea

Kyunghee University Medical Center8 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2007年4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
入组人数
112
试验地点
8
主要终点
Long-term glycemic control

研究概览

简要总结

This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.

详细描述

Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of diabetes. Although the relative importance of these two alterations is controversial, growing evidence is swinging to the concept that there is no hyperglycemia without β-cell dysfunction. Also there is agreement that deterioration of glucose tolerance over time is associated with a progressive decrease of beta cell function.

Beside the role of genetic factor, the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid. A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell. Recently, many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes.

Some studies have shown that early intensive insulin therapy(IIT) to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin. It is suggested that long term glycemic control is associated with improvement of β-cell function.

In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control. To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function, the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.

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 drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
  • Initial HbA1c : 8.0 % ≤ HbA1c < 12.0%

排除标准

  • Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
  • Patients with proliferative diabetic retinopathy
  • Severe liver disease or AST, ALT ≥ 2.5 x ULN
  • History of lactic acidosis
  • Unstable or severe angina
  • Congestive heart failure
  • Chronic disease treated with continuous corticosteroid therapy
  • Diagnosis of cancer
  • Positive urine pregnancy test or plan to become pregnant during the clinical trial

研究组 & 干预措施

Oral AntiDiabetic Drug

Active Comparator

glimepiride and metformin and/or once daily glargine

干预措施: Oral AntiDiabetic Drug (glimepiride and metformin) (Drug)

intensive insulin group

Experimental

insulin glargine insulin glulisine

干预措施: intensive insulin group (Drug)

结局指标

主要结局

Long-term glycemic control

时间窗: up to 2 years

Change of pancreatic beta cell function

时间窗: up to 2 years

次要结局

  • Inflammatory marker and insulin sensitivity(up to 2 years)
  • Time to reach target goal of blood glucose level(up to 2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong-taek Woo

Professor

Kyunghee University Medical Center

研究点 (8)

Loading locations...

相似试验