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Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery (RABBIT 2-SX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596687
Recruitment Status : Completed
First Posted : January 17, 2008
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Inpatient Hyperglycemia Drug: Insulin glargine Drug: Regular insulin Drug: Insulin glulisine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG > 140
Drug: Insulin glargine
Insulin glargine once daily SQ
Other Name: Lantus

Drug: 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. # 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596687

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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital
Atlanta, Georgia, United States, 30324
Sponsors and Collaborators
Emory University
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Principal Investigator: Guillermo Umpierrez, MD Emory University SOM
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University Identifier: NCT00596687    
Other Study ID Numbers: IRB00005062
First Posted: January 17, 2008    Key Record Dates
Results First Posted: March 12, 2014
Last Update Posted: March 12, 2014
Last Verified: February 2014
Keywords provided by Guillermo Umpierrez, Emory University:
post-op complications
inpatient hyperglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs