Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery - Full Text View

Sponsors and Collaborators:	Emory University Sanofi-Aventis
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00596687

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.

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes Surgery

Drug Information available for: Insulin Insulin glargine Insulin glulisine

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 ]

Estimated Enrollment:	282
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Glargine plus supplemental glulisine	Drug: Insulin glargine and insulin glulisine Insulin glargine once daily plus supplemental insulin glulisine before meals
2: Active Comparator 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:

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.

Contacts and Locations

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

Contacts

Contact: Guillermo Umpierrez, MD	4047781665	geumpie@emory.edu
Contact: Dawn Smiley, MD	4047781664	dsmiley@emory.edu

Locations

United States, Georgia
Grady Memorial Hospital	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Guillermo Umpierrez, MD 404-778-1665 geumpie@emory.edu
Contact: Dawn Smiley, MD 404-778-1664 dsmiley@emory.edu
Sub-Investigator: Dawn Smiley, MD
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30324
Contact: Sol Jacobs, MD
Sub-Investigator: Sol Jacobs, MD

Sponsors and Collaborators

Emory University

Sanofi-Aventis

Investigators

Principal Investigator:

Guillermo Umpierrez, MD

Emory University SOM

More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. Epub 2009 Apr 14.

Responsible Party:	Emory University School of Medicine ( Guillermo Umpierrez, MD )
Study ID Numbers:	e5062, e5062
Study First Received:	January 8, 2008
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00596687 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

diabetes
post-op complications
inpatient hyperglycemia

Study placed in the following topic categories:

Metabolic Diseases
Insulin glulisine
Diabetes Mellitus
Endocrine System Diseases
Serotonin Uptake Inhibitors
Insulin
Hypoglycemic Agents

Hyperglycemia
Postoperative Complications
Diabetes Mellitus, Type 2
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Hyperglycemia
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Glargine
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 11, 2009