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NCT Number: NCT00596687

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inpatient Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Insulin glargine once daily SQ

Other names: Lantus

Regular insulin

Drug

Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO

Other names: Novolin R

insulin glulisine

Drug

scheduled glulisine given SQ at mealtime TID; none given if patient NPO

Other names: Apidra

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: RABBIT 2-SX

Important dates

Study start
2007
Primary completion
2009
Study completion
2013
First posted
Jan 17, 2008
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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