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Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery

NCT00596687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2014-03-12

Study results available
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Summary

High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. In patients who have undergone surgery, high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital complications than treatment with regular insulin per sliding scale (SSRI). The present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment of patients with diabetes by the FDA.

Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta, Georgia. A total of \~94 patients will be recruited at each institution.

A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial will be completed in order to determine differences in hospitalization cost between basal bolus insulin and SSI regimen.

Conditions

Interventions

DRUG

Insulin glargine

Insulin glargine once daily SQ

DRUG

Regular insulin

Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO

DRUG

Insulin glulisine

scheduled glulisine given SQ at mealtime TID; none given if patient NPO

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Guillermo Umpierrez, MD · Emory University SOM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-12-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596687 on ClinicalTrials.gov