Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
Information source: Kyunghee University Medical Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Pancreatic Beta Cell Function; Glucotoxicity
Intervention: Intensive Insulin Therapy - Multiple Daily Injection (Drug); Combined Oral Antidiabetic Drug (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Kyunghee University Medical Center Official(s) and/or principal investigator(s):
Jeong-taek Woo, MD, PhD, Principal Investigator, Affiliation: Kyunghee University Medical Center
Overall contact:
Jeong-taek Woo, MD, PhD, Phone: +82-2-958-8128, Email: jtwoomd@khmc.or.kr
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Primary outcome 1.Long-term glycemic control(HbA1c) 2.Change of pancreatic beta cell function
Secondary outcome: Secondary Outcome
1.Time to reach target goal of blood glucose level
2.Inflammatory marker and insulin sensitivity
Detailed description:
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
Minimum age: 25 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
Locations and Contacts
Jeong-taek Woo, MD, PhD, Phone: +82-2-958-8128, Email: jtwoomd@khmc.or.kr
Kyunghee University Medical Center, Seoul 130-702, Korea, Republic of; Recruiting
Suk Chon, MD,PhD, Phone: +82-2-958-8843, Email: imdrjs@khu.ac.kr
Jeong-taek Woo, MD, PhD, Phone: +82-2-958-8128, Email: jtwoomd@khmc.or.kr
Jeong-taek Woo, MD,PhD, Principal 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, Sub-Investigator
Korea University Guro Hospital, Seoul 152-730, Korea, Republic of; Recruiting
Sei Hyun Baik, Md, PhD, Phone: +82-2-818-6645, Email: 103hyun@korea.ac.kr
Sei Hyun Baik, MD, PhD, Principal Investigator
Inha University Hospital, In Cheon 400-711, Korea, Republic of; Recruiting
Moon-Suk Nam, MD,PhD, Phone: +82-32-890-3495, Email: namms@inha.ac.kr
Moon-Suk Nam, MD,PhD, Principal Investigator
Ajou University Medical Center, Suwon 443-721, Korea, Republic of; Recruiting
Kwan-Woo Lee, MD,PhD, Phone: +82-31-219-4526, Email: LKW65@ajou.ac.kr
Kwan-Woo Lee, MD,PhD, Principal Investigator
Hanyang University Medical Center, Kuri, Kyunggi-do 471-020, Korea, Republic of; Recruiting
Yongsoo Park, MD, PhD, Phone: +82-31-553-7369, Email: parkys@hanyang.ac.kr
Yongsoo Park, MD,PhD, Principal Investigator
Additional Information
Starting date: April 2007
Ending date: June 2011
Last updated: December 29, 2008
|
