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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
| Hanyang University | OTHER |
| Inha University Hospital | OTHER |
| Ajou University |
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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In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral AntiDiabetic Drug | Active Comparator | glimepiride and metformin and/or once daily glargine |
|
| intensive insulin group | Experimental | insulin glargine insulin glulisine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive insulin group | Drug | Once daily long acting insulin and preprandial rapid acting insulin injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term glycemic control | up to 2 years | |
| Change of pancreatic beta cell function | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory marker and insulin sensitivity | up to 2 years | |
| Time to reach target goal of blood glucose level | up to 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong-taek Woo, MD, PhD | Kyunghee University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Medical Center | Guri-si | Gyeonggi-do | 471-020 | South Korea | ||
| The Catholic University of Korea Bucheon St.Mary's Hospital |
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| OTHER |
| Sanofi | INDUSTRY |
| East West Neo Medical Center | OTHER |
| The Catholic University of Korea | OTHER |
| Jeju National University Hospital | OTHER |
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| Oral AntiDiabetic Drug (glimepiride and metformin) | Drug | glimepiride and metformin combined therapy |
|
|
| Bucheon-si |
| South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Jeju National University Hospital | Jeju-do | South Korea |
| Kyunghee University Medical Center | Seoul | 130-702 | South Korea |
| Korea University Guro Hospital | Seoul | 152-730 | South Korea |
| Kyung Hee University East Weast Neo Medicalcenter | Seoul | South Korea |
| Ajou University Medical Center | Suwon | 443-721 | South Korea |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007004 | Hypoglycemic Agents |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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