Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy - Full Text View

Sponsor:	Kyunghee University Medical Center
Collaborators:	Korea University Guro Hospital Hanyang University Inha University Hospital Ajou University Sanofi-Aventis 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

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Glimepiride Metformin Metformin hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	132
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2012
Estimated 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

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-Aventis

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:	January 26, 2012
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 February 09, 2012