Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy (KIIT)
Primary Purpose
Type 2 Diabetes Mellitus, Pancreatic Beta Cell Function, Glucotoxicity
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intensive insulin group
Oral AntiDiabetic Drug (glimepiride and metformin)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, intensive insulin therapy
Eligibility 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
Sites / Locations
- Hanyang University Medical Center
- The Catholic University of Korea Bucheon St.Mary's Hospital
- Inha University Hospital
- Jeju National University Hospital
- Kyunghee University Medical Center
- Korea University Guro Hospital
- Kyung Hee University East Weast Neo Medicalcenter
- Ajou University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oral AntiDiabetic Drug
intensive insulin group
Arm Description
glimepiride and metformin and/or once daily glargine
insulin glargine insulin glulisine
Outcomes
Primary Outcome Measures
Long-term glycemic control
Change of pancreatic beta cell function
Secondary Outcome Measures
Inflammatory marker and insulin sensitivity
Time to reach target goal of blood glucose level
Full Information
NCT ID
NCT00474838
First Posted
May 16, 2007
Last Updated
September 25, 2013
Sponsor
Kyunghee University Medical Center
Collaborators
Korea University Guro Hospital, Hanyang University, Inha University Hospital, Ajou University, Sanofi, East West Neo Medical Center, The Catholic University of Korea, Jeju National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00474838
Brief Title
Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
Acronym
KIIT
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Korea University Guro Hospital, Hanyang University, Inha University Hospital, Ajou University, Sanofi, East West Neo Medical Center, The Catholic University of Korea, Jeju National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Pancreatic Beta Cell Function, Glucotoxicity
Keywords
type 2 diabetes mellitus, intensive insulin therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral AntiDiabetic Drug
Arm Type
Active Comparator
Arm Description
glimepiride and metformin and/or once daily glargine
Arm Title
intensive insulin group
Arm Type
Experimental
Arm Description
insulin glargine insulin glulisine
Intervention Type
Drug
Intervention Name(s)
intensive insulin group
Intervention Description
Once daily long acting insulin and preprandial rapid acting insulin injection
Intervention Type
Drug
Intervention Name(s)
Oral AntiDiabetic Drug (glimepiride and metformin)
Other Intervention Name(s)
glimepiride(amaryl), metformin(diabex)
Intervention Description
glimepiride and metformin combined therapy
Primary Outcome Measure Information:
Title
Long-term glycemic control
Time Frame
up to 2 years
Title
Change of pancreatic beta cell function
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Inflammatory marker and insulin sensitivity
Time Frame
up to 2 years
Title
Time to reach target goal of blood glucose level
Time Frame
up to 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-taek Woo, MD, PhD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Medical Center
City
Kuri
State/Province
Kyunggi-do
ZIP/Postal Code
471-020
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Bucheon St.Mary's Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
In Cheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju-do
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-730
Country
Korea, Republic of
Facility Name
Kyung Hee University East Weast Neo Medicalcenter
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
We'll reach out to this number within 24 hrs