Clinical trial NCT00506194: Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
oral glucose tolerance test
insulin
oral anti-diabetic drug
ß-cell function
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2007-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Improve long term glycemic control
timeFrame: 5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Medicine
Study officials:
affiliation: Division of endocrinology and metabolism, Department of medicien, Taipei Veterans General Hospital
name: Harn-Shen Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen HS, Wu TE, Jap TS, Hsiao LC, Lee SH, Lin HD. Beneficial effects of insulin on glycemic control and beta-cell function in newly diagnosed type 2 diabetes with severe hyperglycemia after short-term intensive insulin therapy. Diabetes Care. 2008 Oct;31(10):1927-32. doi: 10.2337/dc08-0075. Epub 2008 Jun 12.