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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00506194
Enrollment
60
Registered
2007-07-25
Start date
2005-10-31
Completion date
2011-12-31
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, oral glucose tolerance test, insulin, oral anti-diabetic drug, ß-cell function

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.

Interventions

DRUGInsulin
DRUGOAD

Gliclazide-MR, Metformin, Glimepiride

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Improve long term glycemic control5 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026