Intravenous Exenatide in Patients With Acute Brain Injury

NCT02058940 | Completed Phase 4 Results

• 3 other identifiers: 13-1391Astra Zeneca PharmaceuticalsMedtronic MiniMed, Inc
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria

  Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (\<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy. The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (\<40 mg/dL) or nausea requiring exenatide discontinuation.

  Over 48 hours from infusion initiation

Secondary Outcomes (18)

• Median Glucose Concentration During Exenatide Infusion

  Over 48 hours from infusion initiation

• Percentage of Glucose Measurements Within Goal Range

  Over 48 hours from infusion initiation

• Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)

  Over 48 hours from infusion initiation

• Glycemic Variability

  Over 48 hours from infusion initiation

• Median Insulin Use

  Over 48 hours from infusion initiation

Study Arms (1)

Exenatide

EXPERIMENTAL

Drug: Exenatide

Interventions

Exenatide DRUG

50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours

Exenatide

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• AstraZeneca: collaborator
• Medtronic: collaborator

Study Sites (1)

University of North Carolina; UNC Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Limitations and Caveats

Trial ended early and did not achieve targeted recruitment goals.

Results Point of Contact

• Title: Nicole R. Pinelli
• Organization: The University of North Carolina at Chapel Hill

nickipinelli@unc.edu

919-962-1641

Study Officials

• Nicole R. Pinelli, PharmD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2017-09

Locations

US (1)