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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes, Inpatient Hyperglycemia

Intervention / Treatment
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* Drug: Insulin glargine
* Drug: Regular insulin
* Drug: Insulin glulisine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females between the ages of 18 and 80 years admitted to a general surgery service. Patients admitted for non-cardiac elective or emergency surgery or trauma. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones). Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones). Exclusion Criteria: Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria. Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU). Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Female subjects are pregnant or breast feeding at time of enrollment into the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG > 140 | Drug: Insulin glargine<br>* Insulin glargine once daily SQ<br>* Other names: Lantus;Drug: Insulin glulisine<br>* scheduled glulisine given SQ at mealtime TID; none given if patient NPO<br>* Other names: Apidra;|
| Active Comparator: 2<br>Sliding scale regular insulin four-times daily achs. | Drug: Regular insulin<br>* Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO<br>* Other names: Novolin R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Glucose Concentration | blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment | hospital stay days 2-10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # Participants With Hypoglycemic Events | number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl) | hospital stay days 2-10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, post-op complications, inpatient hyperglycemia