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ExSTRESS

CompletedPhase 2, PHASE3

Exenatide for Stress Hyperglycemia

Intravenous Exenatide (Byetta®) Versus Insulin for Perioperative Glycemic Control in Cardiac Surgery: the Open-labeled Randomized Phase II/III ExStress Study

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

110

actual

Study population

Cardiovascular disease, Perioperative / gastric aspiration risk

Key I/E criterion

—

Primary endpoint

•CGM time-in-range

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 IDNCT01969149

Org study IDAPI/2009/10

Timeline

Milestones

Study first posted2013-10-25estimated

Last update posted2017-10-06actual

Study start2015-01 (month precision)

Primary completion2015-12actual (month precision)

Study completion2016-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Cardiovascular diseasePerioperative / gastric aspiration risk

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age over 18.

•Patient consent.

•Non insulin requiring type 2 diabetic patients.

•Non diabetic patients.

•Planned coronary artery bypass graft (CABG) surgery.

•ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion criteria

•Pregnancy and breast feeding.

•Pancreatectomy.

•Acute pancreatitis.

•Chronic pancreatitis.

•Type 1 diabetic patients.

•Insulin requiring type 2 patients.

•HbA1c>8%

•Ketoacidosis.

•Hyperosmolar coma.

•Preoperative blood glucose level above 300 mg/dl [21].

•Insulin or exenatide contraindication.

•History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.

•Emergency surgery.

•Planned non CABG cardiac surgery.

Endpoints (14)

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

Cardiovascular outcomes

Safety / tolerability / PK

Other clinical outcomes

Cardiovascular outcomes

3 endpoints

Secondary/protocol endpoint

Mortality

Time frame:Day 30

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Perioperative cardiac mortality

Time frame:Day 30

Cardiovascular death

time to event, event

Secondary/protocol endpoint

Perioperative non cardiac mortality

Time frame:Day 30

All-cause death

time to event, event

SNOMED 419620001

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Percentage of patients spending more than 50 % of the time in the glycemic target range (100 to 140 mg/dl)

Time frame:48 hours

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Number of patients needing rescue to insulin therapy protocol

Time frame:48 hours

event count, event

Secondary/protocol endpoint

The mean (GluAve) and standard deviation (GluSD) of blood glucose

Time frame:48 hours

descriptive

Secondary/protocol endpoint/low confidence

The coefficient of variability (GluCV) of blood glucose level

Time frame:48 hours

descriptive

Secondary/protocol endpoint

Mean number of blood glucose measured

Time frame:48 hours

descriptive

Secondary/protocol endpoint

Mean difference between each blood glucose measurement and 120 mg/dl

Time frame:48 hours

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Hypoglycemia

Time frame:48 hours

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Severe hypoglycemia

Time frame:48 hours

Severe hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Number of adverse events occuring in the exenatide group

Time frame:Day 30

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint/low confidence

Postoperative morbidity

Time frame:Day 30

composite event, event

componentsStroke (any), Kidney-replacement therapy, Myocardial infarction (any)

Secondary/protocol endpoint/low confidence

Length of stay in intensive care unit

Time frame:Day 30

descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial.
Cardiovascular diabetology2018 Nov 1PMID30384842doi:10.1186/s12933-018-0784-yvia clinicaltrials gov reference derived + pubmed nct search
The glucoregulatory benefits of glucagon-like peptide-1 (7-36) amide infusion during intensive insulin therapy in critically ill surgical patients: a pilot study.
Critical care medicine2014 Mar (month)PMID24247476doi:10.1097/CCM.0000000000000035via CT.gov background
Efficacy and safety of an insulin infusion protocol during and after cardiac surgery.
Diabetes & metabolism2010 Feb (month)PMID20097589doi:10.1016/j.diabet.2009.05.008via CT.gov background
Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings.
Journal of cardiothoracic and vascular anesthesia2004 Dec (month)PMID15650975doi:10.1053/j.jvca.2004.08.003via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.