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

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)”

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.

A total of 282 subjects with type 2 diabetes 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.

Intervention(s) in this Clinical Trial

• Drug: Insulin glargine and insulin glulisine
  • Insulin glargine once daily plus supplemental insulin glulisine before meals
• Drug: Regular insulin
  • Sliding scale regular insulin four-times daily before meals or every 6 hours if patient NPO

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Glargine plus supplemental glulisine
• Active Comparator: 2
  • Sliding scale regular insulin four-times daily.

Primary Measures

• To determine differences in glycemic control as measured by mean daily blood glucose concentration between insulin glargine once daily plus supplemental glulisine insulin versus sliding scale regular insulin in surgical patients with type 2 diabetes.
  • Time Frame: at the end of patient hospitalization and again once all subjects have been recruited
    Safety Issue?: Yes

Secondary Measures

• To determine differences between treatment arms in: # of hypoglycemic events, # of episodes of severe hyperglycemia, LOS,rate of post-op complications, and/or need for ICU admission
  • Time Frame: at the end of patient hospitalization and again once all subjects have been recruited
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Males or females between the ages of 18 and 80 years admitted to a general surgery service.
• 2. Patients admitted for non-cardiac elective or emergency surgery or trauma.
• 3. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
• 4. 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:

• 1. Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
• 2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
• 3. Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU).
• 4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
• 5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• 6. Female subjects are pregnant or breast feeding at time of enrollment into the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Emory University Other

Overall Clinical Trial Officials and Contacts

Guillermo Umpierrez, MD Principal Investigator Emory University SOM  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00596687

Study ID Number: e5062

ClinicalTrials.gov Identifier: NCT00596687

Health Authority: United States: Institutional Review Board