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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Intravenous Exenatide in Patients With Acute Brain Injury

NCTNCT02058940 (opens ClinicalTrials.gov in a new tab)Other id13-1391Other idAstra Zeneca PharmaceuticalsOther idMedtronic MiniMed, Inc
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
8 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2015
Primary completion
Aug 2017
Completion
Aug 2017
First posted
10 Feb 2014 (estimated)
Last update posted
12 Jul 2018
Conditions
Brain Injuries

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    Intravenous Exenatide in Patients With Acute Brain Injury

    NCT02058940

    Aug 2015 to Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ExenatideDrug

Arms1

  • Experimental

    Exenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Over 48 hours from infusion initiation

    Registry description

    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.

Secondary outcomes(18)

  1. Median Glucose Concentration During Exenatide Infusion

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours

  2. Percentage of Glucose Measurements Within Goal Range

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Percentage of glucose measurements within goal range is calculated as the number of glucose measurements within goal range (110-180 mg/dL) for all patients/total number of glucose measurements collected for all patients.

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

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours

  4. Glycemic Variability

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours

  5. Median Insulin Use

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from number of insulin units administered over 48 hours starting at infusion initiation

  6. Percentage of Patients Requiring Rescue Insulin Infusion Protocol

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment

  7. Percentage of Hypoglycemic Episodes (<80 mg/dL)

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Percentage of hypoglycemic episodes is calculated as the total number of glucose measurements \<80 mg/dL for all patients/total number of glucose measurements collected for all patients.

  8. Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours

  9. Percentage of Patients Experiencing Metabolic Crisis

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Metabolic crisis is defined as cerebral microdialysate glucose concentration \<0.7 mmol/L in combination with lactate pyruvate ratio \>40. Calculated from hourly microdialysis samples starting at infusion initiation over 48 hours

  10. Median Daily Intracranial Pressure

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from hourly measurements starting at infusion initiation over 48 hours

  11. Median Daily Cerebral Perfusion Pressure

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from hourly measurements starting at infusion initiation over 48 hours

  12. Percentage of Hypotensive Episodes (SBP<100 mmHg)

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Defined as the number of hypotensive episodes (SBP\<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.

  13. Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Calculated from blood pressure measurements starting at infusion initiation over 48 hours

  14. Correlation of Exenatide Concentrations With Creatinine Clearance

    Time frame · Over 48 hours from infusion initiation

    Registry description

    Spearman's correlation coefficient calculated from exenatide concentrations and urine creatinine measurements collected for all patients during the study period. A correlation coefficient is a numerical measure of some type of correlation, meaning a statistical relationship between two variables. Spearman's correlation coefficient assumes values in the range from -1 to +1, where +1 indicates the strongest possible agreement and -1 the strongest possible disagreement.

  15. Exenatide Elimination Rate Constant After Discontinuation of Infusion

    Time frame · 24 hours

  16. Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion

    Time frame · 24 hours

  17. Median Intensive Care Unit Length of Stay

    Time frame · From enrollment to 30 days post study drug discontinuation

    Registry description

    Defined as the number of days admitted to the Intensive Care Unit

  18. Median Hospital Length of Stay

    Time frame · From enrollment to 30 days post study drug discontinuation

    Registry description

    Defined as the number of days admitted to the hospital

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Over 48 hours from infusion initiation

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

GroupValue (percentage of patients)
Exenatide0
Secondary and other outcome results(7)
Secondary outcomeMedian· Over 48 hours from infusion initiation

Median Glucose Concentration During Exenatide Infusion

GroupValue (mg/dL)
Exenatide137.0
Secondary outcomeNumber· Over 48 hours from infusion initiation

Percentage of Glucose Measurements Within Goal Range

GroupValue (percentage of measurements)
Exenatide69.6
Secondary outcomeMedian· Over 48 hours from infusion initiation

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

GroupValue (minutes)
Exenatide200.0
Secondary outcomeMedian· Over 48 hours from infusion initiation

Glycemic Variability

GroupValue (mg/dL)
Exenatide22.2
Secondary outcomeMedian· Over 48 hours from infusion initiation

Median Insulin Use

GroupValue (units/kg)
Exenatide0.03
Secondary outcomeNumber· Over 48 hours from infusion initiation

Percentage of Patients Requiring Rescue Insulin Infusion Protocol

GroupValue (percentage of patients)
Exenatide0
Secondary outcomeNumber· Over 48 hours from infusion initiation

Percentage of Hypoglycemic Episodes (<80 mg/dL)

GroupValue (percentage of measurements)
Exenatide1.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatideExenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours3 / 83 / 80 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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