CompletedPhase 1, PHASE2Results posted

Intravenous Exenatide (Byetta) During Surgery

Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial

Lead sponsor

Thomas Jefferson University

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

104

Study population

Perioperative / gastric aspiration risk

Eligibility highlights

Primary endpoint

•Primary Objective is to Determine the Ability of Intravenous Exenatide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00882050

Org study ID808104

Timeline

Milestones

Study first posted2009-04-16estimated

Last update posted2022-01-21actual

Results first posted2022-01-21actual

Study start2009-03 (month precision)

Primary completion2016-04actual (month precision)

Study completion2016-04actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Perioperative / gastric aspiration risk

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age (>18 years)

•Weight of > 50 kg and < 150 kg

•Ability to provide informed consent

•Elective surgery including:

•Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery)

•Abdominal aortic aneurysm repair

•Carotid endarterectomy

•Esophagectomy

•Cystectomy

•Nephrectomy

•If female, subject must be non-lactating, and, if of childbearing potential, must have a negative urine pregnancy test within 24 hours prior to receiving study drug

Exclusion criteria

•Age (<18 years)

•Inability to provide informed consent

•History or risk of pancreatitis (e.g. ethanol abuse, gall stones)

•Receipt of an investigational drug or device with 30 days prior to surgery

•Use of any concomitant medication listed above on the day of surgery

•Known allergy to Exenatide, fentanyl, midazolam, isoflurane, propofol, heparin or neuromuscular blockers

•Known substance abuse

•Surgical procedure other than:

Cardiac surgery to include elective CABG with or without single or multivalve repair or replacement and/or single or multivalve repair/ replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery)

•Abdominal aortic aneurysm repair

•Carotid endarterectomy

•Esophagectomy

•Cystectomy

•Nephrectomy

-Insulin dependent diabetes mellitis

-Anticipated administration of intraoperative steroids

-Major end organ dysfunction, defined as:

•Current intravenous inotropic agents

•Preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO)

•Renal

•Preoperative serum Creatinine > 2.0 mg/dL

•Hepatic

•History of abnormal hepatic function in the past

•Hematologic

•Preoperative hematocrit (HCT) < 30%

•Platelet count < 100,000/mm3

•History of bleeding or clotting disorder

Endpoints (1)

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.

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

The Primary Objective is to Determine the Ability of Intravenous Exenatide to: Maintain Intraoperative Euglycemia in Subjects With Initial Blood Glucose < 126 mg/dL in Surgical Subjects as Compared to Placebo,

Time frame:Baseline and 90 minutes after starting infusion;

categorical status, improvement

Posted result

Group	Mean · mlg/dL	95% CI
Exentatide 0.27 ng/kg/MinPre glucose levels	112.3	-
at 90 minutes post infusion glucose levels	120.3	-
Exenatide 0.41ng/kg/MinPre glucose levels	108.1	-
at 90 minutes post infusion glucose levels	125.0	-
Placebo IV NSSPre glucose levels	110.4	-
at 90 minutes post infusion glucose levels	120.8	-

p0.05Regression, Logistic

logistic regression

p0.05Regression, Logistic

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.