Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control

Type 2 Diabetes Clinical Trial

Official title:

Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control Is Associated With Improvement of ß-Cell Function in Newly Diagnosed Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506194
• Other study ID #: VGH 94-09-09
• Status: Completed
• Phase: N/A
• First received: July 24, 2007
• Last updated: September 30, 2013
• Start date: October 2005
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We designed this prospective, randomized control study to compare the benefits between the insulin therapy and OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.

Description:

OBJECTIVE—Type 2 diabetes is associated with defects in insulin secretion and insulin action. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify any characteristics of patients with newly diagnosed type 2 diabetes (fasting glucose >300mg/dL) who would have a long-term benefit, in terms of glycemic control, from a brief course of insulin therapy.

RESEARCH DESIGN AND METHODS—Newly diagnosed type 2 diabetic patients with severe hyperglycemia (fasting blood glucose >300 mg/dL or random blood glucose >400 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. Oral glucose tolerance will be performed after one week of intensive insulin treatment. After discharge, patients will be randomized to receive insulin injection or oral anti-diabetic drug for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. Oral glucose tolerance test will be repeated 6 months later, whereas the insulin sensitivity and beta-cell function will be evaluated again.

EXPECTED RESULTS—We will respect that short-term intensive insulin therapy can induce lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Newly diagnosed type 2 diabetic patients.

2. Hospitalization due to hyperglycemia hyperosmolality syndrome.

3. Those who age between 30 and 80 years old and can inject insulin by themselves.

Exclusion Criteria:

1. Pregnant women.

2. Impaired liver function (ALT > 120 U/L)

3. Impaired renal function (Serum creatinine >3.0 mg/dL)

4. Recently suffered from MI or CVA.

5. Patients are acute intercurrent illness.

6. 2-hour C-peptide level < 1.8 ng/mL.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin

• OAD
Gliclazide-MR, Metformin, Glimepiride

Locations

Country	Name	City	State
Taiwan	Division of Endocrinology and Metabolism, Department of Medicine	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term intensive insulin therapy can decrease the insulin resistance and improve the Beta-cell function in newly diagnosed type 2 diabetes with severe hyperglycemia.		6 months
Secondary	Improve long term glycemic control		5 years

External Links

•   Taipei Veterans General Hospital