We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00474838
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : September 26, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Pancreatic Beta Cell Function Glucotoxicity Drug: intensive insulin group Drug: Oral AntiDiabetic Drug (glimepiride and metformin) Phase 4

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In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2007
Primary Completion Date : August 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Long-term glycemic control [ Time Frame: up to 2 years ]
  2. Change of pancreatic beta cell function [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Inflammatory marker and insulin sensitivity [ Time Frame: up to 2 years ]
  2. Time to reach target goal of blood glucose level [ Time Frame: up to 2 year ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474838

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
East West Neo Medical Center
The Catholic University of Korea
Jeju National University Hospital
Principal Investigator: Jeong-taek Woo, MD, PhD Kyunghee University Medical Center
More Information

Responsible Party: Jeong-taek Woo, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT00474838     History of Changes
Other Study ID Numbers: KIIT-KMC-0701
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Keywords provided by Jeong-taek Woo, 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
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors