GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02058940

CompletedPhase 4Results posted

Intravenous Exenatide in Patients With Acute Brain Injury

Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury

Lead sponsor

University of North Carolina, Chapel Hill

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Brain Injuries

Key I/E criterion

—

Primary endpoint

•Percentage of Critically Ill Patients With Acute Brain Injury Achieving (Documented hypoglycemia, Nausea, Postprandial glucose)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02058940

Org study ID13-1391

Secondary IDAstra Zeneca PharmaceuticalsD5550L00025/ISSEXEN0038

Secondary IDMedtronic MiniMed, IncNERP14-008

Timeline

Milestones

Study first posted2014-02-10estimated

Last update posted2018-07-12actual

Results first posted2018-07-12actual

Study start2015-08 (month precision)

Primary completion2017-08actual (month precision)

Study completion2017-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Brain Injuries

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Other clinical outcomes

Cardiometabolic biomarkers

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Median Glucose Concentration During Exenatide Infusion

Time frame:Over 48 hours from infusion initiation

descriptive

Posted result

Group	Value (median), mg/dL	95% CI
Exenatide	137.0	118.0 – 164.3

Secondary/protocol endpoint

Percentage of Glucose Measurements Within Goal Range

Time frame:Over 48 hours from infusion initiation

CGM time-in-range

threshold achievement, improvement

Posted result

Group	Value (number), percentage of measurements	95% CI
Exenatide	69.6	—

Secondary/protocol endpoint

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

Time frame:Over 48 hours from infusion initiation

time to event, improvement

Posted result

Group	Value (median), minutes	95% CI
Exenatide	200.0	72.5 – 270.5

Secondary/protocol endpoint

Glycemic Variability

Time frame:Over 48 hours from infusion initiation

descriptive

Posted result

Group	Value (median), mg/dL	95% CI
Exenatide	22.2	15.0 – 36.3

Secondary/protocol endpoint/low confidence

Median Insulin Use

Time frame:Over 48 hours from infusion initiation

descriptive

Posted result

Group	Value (median), units/kg	95% CI
Exenatide	0.03	0.0 – 0.3

Secondary/protocol endpoint

Percentage of Patients Requiring Rescue Insulin Infusion Protocol

Time frame:Over 48 hours from infusion initiation

threshold achievement, improvement

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	0	—

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint/low confidence

Median Daily Cerebral Perfusion Pressure

Time frame:Over 48 hours from infusion initiation

descriptive

Secondary/protocol endpoint

Percentage of Hypotensive Episodes (SBP<100 mmHg)

Time frame:Over 48 hours from infusion initiation

threshold achievement, improvement

LOINC 8480-6

Posted result

Group	Value (number), percentage of measurements	95% CI
Exenatide	1.2	—

Secondary/protocol endpoint

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

Time frame:Over 48 hours from infusion initiation

threshold achievement, event

LOINC 8480-6

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	12.5	—

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Over 48 hours from infusion initiation

threshold achievement, event

componentsDocumented hypoglycemia, Nausea, Postprandial glucose

Posted result

Group	Value (number), percentage of patients	95% CI
ExenatidePercentage Experiencing Severe Hypoglycemia	0	—
Percentage Achieving Glucose within Goal	87.5	—
Percentage with Nausea Requiring Discontinuation	0	—

Secondary/protocol endpoint

Percentage of Hypoglycemic Episodes (<80 mg/dL)

Time frame:Over 48 hours from infusion initiation

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of measurements	95% CI
Exenatide	1.2	—

Secondary/protocol endpoint

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

Time frame:Over 48 hours from infusion initiation

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide	12.5	—

Secondary/protocol endpoint

Correlation of Exenatide Concentrations With Creatinine Clearance

Time frame:Over 48 hours from infusion initiation

Plasma concentration (steady state)

descriptive

Posted result

Group	Value (number), correlation coefficient	95% CI
Exenatide	-0.2	—

p0.2Spearman's Correlation Coefficient

Secondary/protocol endpoint

Exenatide Elimination Rate Constant After Discontinuation of Infusion

Time frame:24 hours

descriptive

Secondary/protocol endpoint

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

Time frame:24 hours

AUC₀–∞

concentration, descriptive

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Percentage of Patients Experiencing Metabolic Crisis

Time frame:Over 48 hours from infusion initiation

threshold achievement, event

Secondary/protocol endpoint

Median Daily Intracranial Pressure

Time frame:Over 48 hours from infusion initiation

descriptive

Secondary/protocol endpoint

Median Intensive Care Unit Length of Stay

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

descriptive

Posted result

Group	Value (median), days	95% CI
Exenatide	9.0	7.8 – 14.8

Secondary/protocol endpoint

Median Hospital Length of Stay

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

descriptive

Posted result

Group	Value (median), days	95% CI
Exenatide	12.5	9.0 – 27.3

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.