Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery (RABBIT 2-SX)
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.
|Type 2 Diabetes Inpatient Hyperglycemia||Drug: Insulin glargine Drug: Regular insulin Drug: Insulin glulisine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)|
- Mean Blood Glucose Concentration [ Time Frame: hospital stay days 2-10 ]blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment
- # Participants With Hypoglycemic Events [ Time Frame: hospital stay days 2-10 ]number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl)
|Study Start Date:||December 2007|
|Study Completion Date:||July 2013|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG > 140
Drug: Insulin glargine
Insulin glargine once daily SQ
Other Name: LantusDrug: Insulin glulisine
scheduled glulisine given SQ at mealtime TID; none given if patient NPO
Other Name: Apidra
Active Comparator: 2
Sliding scale regular insulin four-times daily achs.
Drug: Regular insulin
Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO
Other Name: Novolin R
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596687
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30324|
|Principal Investigator:||Guillermo Umpierrez, MD||Emory University SOM|