Brain InjuriesPhase 4NCT02058940

Intravenous Exenatide in Patients With Acute Brain Injury

A Phase 4 study testing Exenatide in people with Brain Injuries, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Injuries
What is being tested?: Exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina; UNC Medical Center
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury

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
Being tested: Exenatide
Medical subject headings: Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02058940
Study group	Role	What they receive
Exenatide	Experimental	Not described Receives: Drug: Exenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Over 48 hours from infusion initiation

Secondary outcomes (18)

Median Glucose Concentration During Exenatide Infusion
Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Percentage of Glucose Measurements Within Goal Range
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.
Measured: Over 48 hours from infusion initiation
Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)
Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Glycemic Variability
Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Median Insulin Use
Calculated from number of insulin units administered over 48 hours starting at infusion initiation
Measured: Over 48 hours from infusion initiation
Percentage of Patients Requiring Rescue Insulin Infusion Protocol
Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment
Measured: Over 48 hours from infusion initiation
Percentage of Hypoglycemic Episodes (<80 mg/dL)
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.
Measured: Over 48 hours from infusion initiation
Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)
Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Percentage of Patients Experiencing Metabolic Crisis
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
Measured: Over 48 hours from infusion initiation
Median Daily Intracranial Pressure
Calculated from hourly measurements starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Median Daily Cerebral Perfusion Pressure
Calculated from hourly measurements starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Percentage of Hypotensive Episodes (SBP<100 mmHg)
Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.
Measured: Over 48 hours from infusion initiation
Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)
Calculated from blood pressure measurements starting at infusion initiation over 48 hours
Measured: Over 48 hours from infusion initiation
Correlation of Exenatide Concentrations With Creatinine Clearance
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.
Measured: Over 48 hours from infusion initiation
Exenatide Elimination Rate Constant After Discontinuation of Infusion
Measured: 24 hours
Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion
Measured: 24 hours
Median Intensive Care Unit Length of Stay
Defined as the number of days admitted to the Intensive Care Unit
Measured: From enrollment to 30 days post study drug discontinuation
Median Hospital Length of Stay
Defined as the number of days admitted to the hospital
Measured: From enrollment to 30 days post study drug discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Aug 2017

First posted10 Feb 2014 (estimated)
Study startAug 2015
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brain InjuriesStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02058940
Sponsor's protocol ID: 13-1391
Other IDs: Astra Zeneca Pharmaceuticals, Medtronic MiniMed, Inc
Status last verified: Sep 2017
First submitted: 6 Feb 2014
Last updated: 12 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury
ClinicalTrials.gov ID: NCT02058940
Acronym / sponsor ID: 13-1391
Conditions: Brain Injuries
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: AstraZeneca, Medtronic
Study start: Aug 2015
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 10 Feb 2014 (estimated)
Results: Posted 12 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Exenatide	Experimental	Drug: Exenatide

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exenatide50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours	Drug	Exenatide

Primary outcome

Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria
Time frame: Over 48 hours from infusion initiation
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.

18 secondary outcomes

Median Glucose Concentration During Exenatide Infusion
Time frame: Over 48 hours from infusion initiation
Percentage of Glucose Measurements Within Goal Range
Time frame: Over 48 hours from infusion initiation
Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)
Time frame: Over 48 hours from infusion initiation
Glycemic Variability
Time frame: Over 48 hours from infusion initiation
Median Insulin Use
Time frame: Over 48 hours from infusion initiation
Percentage of Patients Requiring Rescue Insulin Infusion Protocol
Time frame: Over 48 hours from infusion initiation
Percentage of Hypoglycemic Episodes (<80 mg/dL)
Time frame: Over 48 hours from infusion initiation
Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)
Time frame: Over 48 hours from infusion initiation
Percentage of Patients Experiencing Metabolic Crisis
Time frame: Over 48 hours from infusion initiation
Median Daily Intracranial Pressure
Time frame: Over 48 hours from infusion initiation
Median Daily Cerebral Perfusion Pressure
Time frame: Over 48 hours from infusion initiation
Percentage of Hypotensive Episodes (SBP<100 mmHg)
Time frame: Over 48 hours from infusion initiation
Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)
Time frame: Over 48 hours from infusion initiation
Correlation of Exenatide Concentrations With Creatinine Clearance
Time frame: Over 48 hours from infusion initiation
Exenatide Elimination Rate Constant After Discontinuation of Infusion
Time frame: 24 hours
Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion
Time frame: 24 hours
Median Intensive Care Unit Length of Stay
Time frame: From enrollment to 30 days post study drug discontinuation
Median Hospital Length of Stay
Time frame: From enrollment to 30 days post study drug discontinuation

Results and safety

Results posted to the registry on 12 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide	8	7

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

Time frame: Over 48 hours from infusion initiation. Number. Unit: percentage of patients

Measure	Exenatide n = 8
Percentage Experiencing Severe Hypoglycemia	0
Percentage Achieving Glucose within Goal	87.5
Percentage with Nausea Requiring Discontinuation	0

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study enrollment to 30 days post discontinuation of Exenatide, up to 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide	3 of 8 (37.5%)	0 of 8 (0%)	3 of 8

Limitations and caveats (from the sponsor): Trial ended early and did not achieve targeted recruitment goals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicole R. Pinelli, PharmD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exenatide in people with Brain Injuries, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria (time frame: Over 48 hours from infusion initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02058940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.