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
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In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly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
- 否
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
glimepiride and metformin and/or once daily glargine
干预措施: Oral AntiDiabetic Drug (glimepiride and metformin) (Drug)
intensive insulin group
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
Jeong-taek Woo
Professor
Kyunghee University Medical Center
