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

NCT00506194 | Completed DMC

• 1 other identifier: VGH 94-09-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

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

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Improve long term glycemic control

  5 years

Study Arms (2)

Insulin

EXPERIMENTAL

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

OAD

ACTIVE COMPARATOR

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

Interventions

Insulin DRUG

Also known as: Insulatard, Actrapid, Lantus, monotard

Insulin

OAD DRUG

Gliclazide-MR, Metformin, Glimepiride

Also known as: Diamicron-MR, Glucophage, Amaryl

OAD

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• hour C-peptide level \< 1.8 ng/mL.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Division of Endocrinology and Metabolism, Department of Medicine

Taipei, 112, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 18556343 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin; Isophane Insulin, Human; Insulin Glargine; Metformin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Harn-Shen Chen, MD, PhD

  Division of endocrinology and metabolism, Department of medicien, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: October 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2011
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

TW (1)