CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 234 enrolled
Drug / intervention
Insulin glargine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00596687
NCT00596687Phase 4Completed

RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)

Emory University·interventional·Posted Jan 17, 2008·Updated Mar 12, 2014

In Brief

A Phase 4 clinical trial evaluating Insulin glargine, Regular insulin, and 1 other intervention for Type 2 Diabetes and Inpatient Hyperglycemia. Completed, enrolled 234 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2008
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2009
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.5 years ago

Interventions

Insulin glarginedrug

Insulin glargine once daily SQ

Regular insulindrug

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

Insulin glulisinedrug

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