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| Sponsors and Collaborators: |
Kyunghee University Medical Center Korea University Guro Hospital Hanyang University Inha University Hospital Ajou University Sanofi-Aventis |
|---|---|
| Information provided by: | Kyunghee University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00474838 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus Pancreatic Beta Cell Function Glucotoxicity |
Drug: Intensive Insulin Therapy - Multiple Daily Injection Drug: Combined Oral Antidiabetic Drug |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 132 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| COAD: Active Comparator |
Drug: Combined Oral Antidiabetic Drug
Glimepiride and Metformin administration
|
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IIT: Experimental
Intensive insulin therapy : insulin glargine once daily and insulin glulisine twice daily before meal.
|
Drug: Intensive Insulin Therapy - Multiple Daily Injection
Once daily long acting insulin and preprandial rapid acting insulin injection
|
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 our unpublished previous pilot study, we 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, we will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.
Eligibility| Ages Eligible for Study: | 25 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jeong-taek Woo, MD, PhD | +82-2-958-8128 | jtwoomd@khmc.or.kr |
| Contact: Suk Chon, MD, PhD | 0+82-2-958-8843 | imdrjs@freechal.com |
| Korea, Republic of | |
| Kyunghee University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 130-702 | |
| Contact: Suk Chon, MD,PhD +82-2-958-8843 imdrjs@khu.ac.kr | |
| Contact: Jeong-taek Woo, MD, PhD +82-2-958-8128 jtwoomd@khmc.or.kr | |
| Principal Investigator: Jeong-taek Woo, MD,PhD | |
| Sub-Investigator: Young-Seol Kim, MD, PhD | |
| Sub-Investigator: Jin-Woo Kim, MD,PhD | |
| Sub-Investigator: Sung-Woon Kim, MD, PhD | |
| Sub-Investigator: Seungjoon Oh, MD, PhD | |
| Sub-Investigator: Suk Chon, MD, PhD | |
| Sub-Investigator: Sang Youl Rhee, MD | |
| Korea University Guro Hospital | Recruiting |
| Seoul, Korea, Republic of, 152-730 | |
| Contact: Sei Hyun Baik, Md, PhD +82-2-818-6645 103hyun@korea.ac.kr | |
| Principal Investigator: Sei Hyun Baik, MD, PhD | |
| Inha University Hospital | Recruiting |
| In Cheon, Korea, Republic of, 400-711 | |
| Contact: Moon-Suk Nam, MD,PhD +82-32-890-3495 namms@inha.ac.kr | |
| Principal Investigator: Moon-Suk Nam, MD,PhD | |
| Ajou University Medical Center | Recruiting |
| Suwon, Korea, Republic of, 443-721 | |
| Contact: Kwan-Woo Lee, MD,PhD +82-31-219-4526 LKW65@ajou.ac.kr | |
| Principal Investigator: Kwan-Woo Lee, MD,PhD | |
| Korea, Republic of, Kyunggi-do | |
| Hanyang University Medical Center | Recruiting |
| Kuri, Kyunggi-do, Korea, Republic of, 471-020 | |
| Contact: Yongsoo Park, MD, PhD +82-31-553-7369 parkys@hanyang.ac.kr | |
| Principal Investigator: Yongsoo Park, MD,PhD | |
| Principal Investigator: | Jeong-taek Woo, MD, PhD | Kyunghee University Medical Center |
More Information
| Responsible Party: | Kyung Hee University ( Jeong taek Woo/ Chief of Department of Endocrinology and Metabolism ) |
| Study ID Numbers: | KIIT-KMC-0701 |
| Study First Received: | May 16, 2007 |
| Last Updated: | December 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00474838 |
| Health Authority: | Korea: Food and Drug Administration |
|
type 2 diabetes mellitus intensive insulin therapy |
|
Insulin, Long-Acting Glimepiride Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
|
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
