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

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ClinicalTrials.gov Identifier: NCT00506194
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : October 1, 2013
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: Insulin Drug: OAD

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2005
Primary Completion Date : August 2007
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Insulin
Insulin therapy was initiated at a 75% total daily dose in the last day hospitalization with Insulatard. Two third of daily dose was administered before breakfast and the other was administered at bedtime. Insulin doses were titrated every 3 days to achieve target FPG and pre-supper blood glucose values between 90 and 130 mg/dl. Bedtime insulin doses were titrated based on FPG values and the pre-breakfast dose was titrated base on pre-supper blood glucose.
Drug: Insulin
Other Name: Insulatard, Actrapid, Lantus, monotard
Active Comparator: OAD
Subject in other OAD group was visited every two weeks in the two months and the every four weeks. The subjects will start with Gliclazide-MR 30mg before breakfast, The dosage was titrated based on the fasting blood glucose on the visiting day with the same target. Decreased by 30mg if blood glucose was <70mg /dl, decreased by 15 mg if blood glucose was 70-90mg/dl, no change if blood glucose was 90-130mg/dl, increased by 15 mg if blood glucose was 131-160 mg/dl, increased by 30 mg if blood glucose >160mg/dl. When the Gliclazide-MR dose each to the maximum dose of 60 mg twice daily, Metformin was added. The titration of Metformin was use 250mg for an adjust dosage with the same target.
Drug: OAD
Gliclazide-MR, Metformin, Glimepiride
Other Name: Diamicron-MR, Glucophage, Amaryl


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Improve long term glycemic control [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506194


Locations
Taiwan
Division of Endocrinology and Metabolism, Department of Medicine
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Harn-Shen Chen, MD, PhD Division of endocrinology and metabolism, Department of medicien, Taipei Veterans General Hospital
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00506194     History of Changes
Other Study ID Numbers: VGH 94-09-09
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Taipei Veterans General Hospital, Taiwan:
type 2 diabetes
oral glucose tolerance test
insulin
oral anti-diabetic drug
ß-cell function

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Gliclazide
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs