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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474838
• Other study ID #: KIIT-KMC-0701
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2007
• Last updated: September 25, 2013
• Start date: April 2007
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucotoxicity
• Pancreatic Beta Cell Function
• Type 2 Diabetes Mellitus

Intervention

Drug:
• intensive insulin group
Once daily long acting insulin and preprandial rapid acting insulin injection
• Oral AntiDiabetic Drug (glimepiride and metformin)
glimepiride and metformin combined therapy

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Inha University Hospital	In Cheon
Korea, Republic of	Jeju National University Hospital	Jeju-do
Korea, Republic of	Hanyang University Medical Center	Kuri	Kyunggi-do
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University East Weast Neo Medicalcenter	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (9)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Ajou University, East West Neo Medical Center, Hanyang University, Inha University Hospital, Jeju National University Hospital, Korea University Guro Hospital, Sanofi, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term glycemic control		up to 2 years	No
Primary	Change of pancreatic beta cell function		up to 2 years	No
Secondary	Inflammatory marker and insulin sensitivity		up to 2 years	No
Secondary	Time to reach target goal of blood glucose level		up to 2 year	No