Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
NCT ID: NCT00474838
Last Updated: 2013-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
112 participants
INTERVENTIONAL
2007-04-30
2012-12-31
Brief Summary
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Detailed Description
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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In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral AntiDiabetic Drug
glimepiride and metformin and/or once daily glargine
Oral AntiDiabetic Drug (glimepiride and metformin)
glimepiride and metformin combined therapy
intensive insulin group
insulin glargine insulin glulisine
intensive insulin group
Once daily long acting insulin and preprandial rapid acting insulin injection
Interventions
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intensive insulin group
Once daily long acting insulin and preprandial rapid acting insulin injection
Oral AntiDiabetic Drug (glimepiride and metformin)
glimepiride and metformin combined therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initial HbA1c : 8.0 % ≤ HbA1c \< 12.0%
Exclusion Criteria
* 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
25 Years
70 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Hanyang University
OTHER
Inha University Hospital
OTHER
Ajou University
OTHER
Sanofi
INDUSTRY
East West Neo Medical Center
OTHER
The Catholic University of Korea
OTHER
Jeju National University Hospital
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
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Jeong-taek Woo
Professor
Principal Investigators
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Jeong-taek Woo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Locations
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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
Kyunghee University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University East Weast Neo Medicalcenter
Seoul, , South Korea
Ajou University Medical Center
Suwon, , South Korea
Countries
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Other Identifiers
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KIIT-KMC-0701
Identifier Type: -
Identifier Source: org_study_id