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Completed

NCT Number: NCT00506194

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

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Endocrinology and Metabolism, Department of Medicine

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed type 2 diabetic patients.
  • Hospitalization due to hyperglycemia hyperosmolality syndrome.
  • Those who age between 30 and 80 years old and can inject insulin by themselves.

Exclusion criteria

  • Pregnant women.
  • Impaired liver function (ALT > 120 U/L)
  • Impaired renal function (Serum creatinine >3.0 mg/dL)
  • Recently suffered from MI or CVA.
  • Patients are acute intercurrent illness.
  • 2-hour C-peptide level < 1.8 ng/mL.

Treatment and study plan

Insulin

Drug

Other names: Insulatard, Actrapid, Lantus, monotard

OAD

Drug

Gliclazide-MR, Metformin, Glimepiride

Other names: Diamicron-MR, Glucophage, Amaryl

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Improve long term glycemic control

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Jul 25, 2007
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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