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.
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 In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Once daily long acting insulin and preprandial rapid acting insulin injection
glimepiride and metformin combined therapy
Hanyang University Medical Center
Guri-si, Gyeonggi-do, South Korea
The Catholic University of Korea Bucheon St.Mary's Hospital
Bucheon-si, South Korea
Inha University Hospital
Incheon, South Korea
Jeju National University Hospital
Jeju-do, South Korea
Long-term glycemic control
Time frame: up to 2 years
Change of pancreatic beta cell function
Time frame: up to 2 years
Inflammatory marker and insulin sensitivity
Time frame: up to 2 years
Time to reach target goal of blood glucose level
Time frame: up to 2 year
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Kyunghee University Medical Center
Seoul, South Korea
Korea University Guro Hospital
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Kyung Hee University East Weast Neo Medicalcenter
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Ajou University Medical Center
Suwon, South Korea