Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy (KIIT)

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Jeong-taek Woo, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT00474838
First received: May 16, 2007
Last updated: September 25, 2013
Last verified: September 2013
  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 group
Drug: Oral AntiDiabetic Drug (glimepiride and metformin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Long-term glycemic control [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Change of pancreatic beta cell function [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory marker and insulin sensitivity [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Time to reach target goal of blood glucose level [ Time Frame: up to 2 year ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: April 2007
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral AntiDiabetic Drug
glimepiride and metformin and/or once daily glargine
Drug: Oral AntiDiabetic Drug (glimepiride and metformin)
glimepiride and metformin combined therapy
Other Names:
  • glimepiride(amaryl)
  • metformin(diabex)
Experimental: intensive insulin group
insulin glargine insulin glulisine
Drug: intensive insulin group
Once daily long acting insulin and preprandial rapid acting insulin injection

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474838

Locations
Korea, Republic of
Hanyang University Medical Center
Kuri, Kyunggi-do, Korea, Republic of, 471-020
The Catholic University of Korea Bucheon St.Mary's Hospital
Bucheon, Korea, Republic of
Inha University Hospital
In Cheon, Korea, Republic of, 400-711
Jeju National University Hospital
Jeju-do, Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of, 130-702
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-730
Kyung Hee University East Weast Neo Medicalcenter
Seoul, Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Kyunghee University Medical Center
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
Investigators
Principal Investigator: Jeong-taek Woo, MD, PhD Kyunghee University Medical Center
  More Information

No publications provided

Responsible Party: Jeong-taek Woo, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT00474838     History of Changes
Other Study ID Numbers: KIIT-KMC-0701
Study First Received: May 16, 2007
Last Updated: September 25, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
type 2 diabetes mellitus
intensive insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014