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NCT00596687 · ClinicalTrials.gov registry record · Phase 4
Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 234
- Enrollment target
NCT00596687 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 234 participants.
The verdict
NCT00596687, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 234 participants
- Enrollment target
Study 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.
Interventions
- DRUG Insulin glargine
- DRUG Insulin glulisine
- DRUG Regular insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2007-12 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00596687
The ClinicalTrials.gov registry entry for NCT00596687 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 234 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine is the first listed.
NCT00596687 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00596687 about?
NCT00596687 is a clinical study titled "Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery". 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, hi...
What is the current status of trial NCT00596687?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 234 participants. The study started on 2007-12. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00596687?
The interventions under investigation include: Insulin glargine (DRUG), Insulin glulisine (DRUG), Regular insulin (DRUG).
Who is sponsoring clinical trial NCT00596687?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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