Intravenous Exenatide in Patients With Acute Brain Injury

University of North Carolina (UNC)

Status and phase

Completed

Phase 4

Conditions

Brain Injuries

Treatments

Drug: Exenatide

Study type

Interventional

Funder types

Other

Industry

Identifiers

Medtronic MiniMed, Inc (Other Grant/Funding Number)

13-1391

Astra Zeneca Pharmaceuticals (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults ≥18 years
Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay >48 hours
Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL
Informed consent obtained via proxy

Exclusion criteria

Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females
Type 1 diabetes mellitus
History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)
Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min
Known history of gastroparesis
History of surgery on stomach, esophagus or duodenum
Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome
Concurrent steroid use or planned post-operative steroid use
History of organ transplantation
Brain death or suspected imminent brain death within the next 72 hours
Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg for greater than 15 minutes and refractory to medical intervention
Currently enrolled in another investigational drug or device protocol
Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration
Known allergy to exenatide