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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00596687
First received: January 8, 2008
Last updated: October 4, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
Inpatient Hyperglycemia
 Drug: Insulin glargine and insulin glulisine
Drug: Regular insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 234
Study Start Date: December 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Glargine plus supplemental glulisine
 Drug: Insulin glargine and insulin glulisine
Insulin glargine once daily plus supplemental insulin glulisine before meals
Other Name: Lantus and Apidra
Active Comparator: 2
Sliding scale regular insulin four-times daily.
 Drug: Regular insulin
Sliding scale regular insulin four-times daily before meals or every 6 hours if patient NPO

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596687

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital
Atlanta, Georgia, United States, 30324
Sponsors and Collaborators
Emory University
Sanofi
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University SOM
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00596687     History of Changes
Other Study ID Numbers: e5062, e5062
Study First Received: January 8, 2008
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
diabetes
post-op complications
inpatient hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013