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

NCT00596687 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00005062e5062
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes; Inpatient Hyperglycemia

Keywords

diabetes; post-op complications; inpatient hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Mean Blood Glucose Concentration

  blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment

  hospital stay days 2-10

Secondary Outcomes (1)

• # Participants With Hypoglycemic Events

  hospital stay days 2-10

Study Arms (2)

1

EXPERIMENTAL

Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG \> 140

Drug: Insulin glargine; Drug: Insulin glulisine

2

ACTIVE COMPARATOR

Sliding scale regular insulin four-times daily achs.

Drug: Regular insulin

Interventions

Insulin glargine DRUG

Insulin glargine once daily SQ

Also known as: Lantus

1

Regular insulin DRUG

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

Also known as: Novolin R

2

Insulin glulisine DRUG

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

Also known as: Apidra

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30324, United States

Location

Related Publications (2)

• Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.

  PMID: 21228246 RESULT

• Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron 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. doi: 10.2337/dc09-0169. Epub 2009 Apr 14.

  PMID: 19366972 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Glargine; Insulin; insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Results Point of Contact

• Title: Guillermo Umpierrez
• Organization: Emory Univ SOM

geumpie@emory.edu

4047781665

Study Officials

• Guillermo Umpierrez, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2013
• Last Updated: March 12, 2014
• Results First Posted: March 12, 2014

Record last verified: 2014-02

Locations

US (2)