Skip to main content
Delfa

← All trials/NCT03743025

TerminatedPhase 4Results posted

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Lead sponsor

Emory University

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

-

Actual enrollment

28

Study population

Cardiovascular disease, Obesity / overweight, Perioperative / gastric aspiration risk

Eligibility highlights

•BMI ≥25

Primary endpoint

•Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

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 IDNCT03743025
Org study IDIRB00097963
Secondary ID1K23GM128221-01A1

Timeline

Milestones

Study first posted2018-11-15actual
Study start2019-03-08actual
Primary completion2023-05-02actual
Study completion2023-05-02actual
Last update posted2024-05-30actual
Results first posted2024-05-30actual

Assets

Investigational agents

Dulaglutide

Who this study enrolls

Cardiovascular diseaseObesity / overweightPerioperative / gastric aspiration risk

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Males or females between the ages of 40 and 80 years
•Body mass index (BMI) ≥25
•Undergoing elective CABG surgery
•No previous history of diabetes or hyperglycemia

Exclusion criteria

•Hyperglycemia (BG>125 mg/dl or HbA1c > 6.5%) or previous treatment with antidiabetic agents
•Impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
•Gastrointestinal obstruction expected to require gastrointestinal suction
•Patients with clinically relevant pancreatic or gallbladder disease
•Treatment with oral or injectable corticosteroid
•Mental condition rendering the subject unable to understand the possible consequences of the study
•Pregnancy or breastfeeding at time of enrollment

Endpoints (38)

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
19
Safety / tolerability / PK
8
Other clinical outcomes
8
Cardiovascular outcomes
3

Cardiovascular outcomes

3 endpoints
Secondary/registry result

Number of Cerebrovascular Events

Time frame:During the hospital stay (up to 12 days postoperatively)

CV events (total recurrent)

event count, event

Posted result

GroupNumber · cerebrovascular events95% CI
Dulaglutide0-
Placebo0-
Secondary/registry result

Participant Mortality

Time frame:During the hospital stay (up to 12 days postoperatively)

All-cause death

event count, event

SNOMED 419620001

Posted result

GroupParticipants95% CI
DulaglutideICU deaths0-
Non-ICU hospital deaths0-
PlaceboICU deaths0-
Non-ICU hospital deaths0-
Secondary/protocol endpoint

Number of Cerebrovascular Events

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

Glycemic / diabetes

19 endpoints
Primary/registry result

Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

Time frame:During the hospital stay (up to 12 days postoperatively)

threshold achievement, improvement

Posted result

GroupParticipants95% CI
Dulaglutide11-
Placebo13-
Primary/protocol endpoint

Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

Time frame:During the hospital stay (up to 12 days postoperatively)

threshold achievement, event

Secondary/registry result

Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Posted result

GroupMean · mg/dL95% CI
Dulaglutide134.11-
Placebo129.79-
Secondary/registry result

Number of Participants Needing CII Treatment in the ICU

Time frame:During the ICU stay (up to 7 days postoperatively)

threshold achievement, improvement

Posted result

GroupParticipants95% CI
Dulaglutide11-
Placebo12-
Secondary/registry result

Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

Posted result

GroupParticipants95% CI
Dulaglutide6-
Placebo4-
Secondary/registry result

Mean Blood Glucose Levels During the Hospital Stay

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive, improvement

Posted result

GroupMean · mg/dL95% CI
Dulaglutide119.69-
Placebo117.69-
Secondary/registry result/low confidence

Mean Units Per Hour of Insulin While in the ICU

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Posted result

GroupMean · insulin units/hour95% CI
Dulaglutide2.89-
Placebo2.01-
Secondary/registry result/low confidence

Mean Insulin Dose Per Day While in the ICU

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Posted result

GroupMean · insulin units/day95% CI
Dulaglutide61.15-
Placebo33.01-
Secondary/registry result/low confidence

Duration of Continuous Insulin Infusion (CII)

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Posted result

GroupMean · hours95% CI
Dulaglutide18.90-
Placebo16.69-
Secondary/registry result

Days of Subcutaneous (SC) Insulin After Discontinuation of CII

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Posted result

GroupMean · days95% CI
Dulaglutide2.00-
Placebo3.50-
Secondary/registry result

Amount of SC Insulin Administered

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Posted result

GroupMean · units of insulin95% CI
Dulaglutide8.25-
Placebo10.92-
Secondary/protocol endpoint

Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive, improvement

Secondary/protocol endpoint

Number of Participants Needing CII Treatment in the ICU

Time frame:During the ICU stay (up to 7 days postoperatively)

threshold achievement, improvement

Secondary/protocol endpoint

Mean Blood Glucose Levels During the Hospital Stay

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive, improvement

Secondary/protocol endpoint/low confidence

Mean Units Per Hour of Insulin While in the ICU

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Secondary/protocol endpoint

Mean Insulin Dose Per Day While in the ICU

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Secondary/protocol endpoint/low confidence

Duration of Continuous Insulin Infusion (CII)

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Secondary/protocol endpoint/low confidence

Days of Subcutaneous (SC) Insulin After Discontinuation of CII

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Secondary/protocol endpoint/low confidence

Amount of SC Insulin Administered

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Safety / tolerability / PK

8 endpoints
Secondary/registry result

Number of Participants Experiencing Hyperglycemic Events

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

Posted result

GroupParticipants95% CI
Dulaglutide1-
Placebo2-
Secondary/registry result

Number of Participants Experiencing Hypoglycemic Events

Time frame:During the hospital stay (up to 12 days postoperatively)

Documented hypoglycemia

event count, event

Posted result

GroupParticipants95% CI
DulaglutideBG <70 mg/dL0-
BG <54 mg/dL0-
BG <40 mg/dL0-
PlaceboBG <70 mg/dL0-
BG <54 mg/dL0-
BG <40 mg/dL0-
Secondary/registry result

Number of Participants Experiencing Gastrointestinal Adverse Events

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

componentsNausea, Vomiting, Pancreatitis

Posted result

GroupParticipants95% CI
Dulaglutide3-
Placebo1-
Secondary/protocol endpoint

Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII

Time frame:During the hospital stay (up to 12 days postoperatively)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants Experiencing Hyperglycemic Events

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Hypoglycemic Events

Time frame:During the hospital stay (up to 12 days postoperatively)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Gastrointestinal Adverse Events

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

componentsNausea, Vomiting, Pancreatitis

Secondary/protocol endpoint

Participant Mortality

Time frame:During the hospital stay (up to 12 days postoperatively)

Death (safety endpoint)

event count, event

SNOMED 419620001

Other clinical outcomes

8 endpoints
Secondary/registry result/low confidence

Number of Participants Experiencing Mortality and Complications

Time frame:During the hospital stay (up to 12 days postoperatively)

composite event, event

componentsAll-cause death, Myocardial infarction (any)

Posted result

GroupParticipants95% CI
Dulaglutide2-
Placebo1-
Secondary/registry result

ICU Length of Stay

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Posted result

GroupMean · days95% CI
Dulaglutide2.19-
Placebo2.76-
Secondary/registry result

Hospital Length of Stay

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Posted result

GroupMean · days95% CI
Dulaglutide7.25-
Placebo8.92-
Secondary/registry result

Number of ICU Readmissions

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

Posted result

GroupNumber · ICU readmissions95% CI
Dulaglutide0-
Placebo0-
Secondary/protocol endpoint/low confidence

Number of Participants Experiencing Mortality and Complications

Time frame:During the hospital stay (up to 12 days postoperatively)

composite event, event

componentsAll-cause death, Myocardial infarction (any)

Secondary/protocol endpoint

ICU Length of Stay

Time frame:During the ICU stay (up to 7 days postoperatively)

descriptive

Secondary/protocol endpoint

Hospital Length of Stay

Time frame:During the hospital stay (up to 12 days postoperatively)

descriptive

Secondary/protocol endpoint

Number of ICU Readmissions

Time frame:During the hospital stay (up to 12 days postoperatively)

event count, event

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.