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CompletedPhase 4Results posted

Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

40

actual

Study population

Cardiovascular disease, Prediabetes / glucose intolerance

Key I/E criterion

Primary endpoints

Median Glucose Values From Steady StateSteady State

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 IDNCT00736229
Org study ID08-206

Timeline

Milestones

Study first posted2008-08-15estimated
Last update posted2014-11-20estimated
Results first posted2014-11-20estimated
Study start2008-08 (month precision)
Primary completion2011-06actual (month precision)
Study completion2012-08actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseasePrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Admission to coronary ICU
Admission blood glucose 140-299 mg/dL
Primary cardiovascular diagnosis by attending physician
Under primary care of cardiology service
Age > 18 years old
Ventilator independent
Able to provide informed consent

Exclusion criteria

Admission blood glucose < 140 or > 300 mg/dL
Ventilator dependent
Unconscious sedation
Type 1 diabetes
Known pregnancy
Admitted to coronary ICU for right heart cath to measure hemodynamics prior to transplant
Post transplant procedure
Currently enrolled in another clinical trial
Unable to provide informed consent
Creatinine clearance < 30 mL/min
On insulin treatment except for monotherapy with long-acting basal insulin (e.g., insulin glargine [Lantus®] or detemir [Levemir®])
Gastroparesis

Endpoints (4)

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
2
Safety / tolerability / PK
2

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Median Glucose Values From Steady State Through 48 Hours or Until Discharge.

Time frame:1-48 hours

descriptive, improvement

Posted result

GroupValue (median), mg/dL95% CI
Exenatide132110 – 157
Moderate127105 – 161
Intensive10592 – 128
p<0.001Kruskal-Wallis

Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.

p<0.001Wilcoxon (Mann-Whitney)

Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.

p0.15Wilcoxon (Mann-Whitney)

Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.

Primary/protocol endpoint

Time to Steady State

Time frame:Start of infusion through 48 hours or until discharge

time to event, improvement

Posted result

GroupValue (median), hours95% CI
Exenatide2.01.5 – 5.0
Moderate12.07.0 – 15.0
Intensive3.01.0 – 5.0
p<0.001Kruskal-Wallis

Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.

p0.80Wilcoxon (Mann-Whitney)

Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.

p<0.001Wilcoxon (Mann-Whitney)

Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Rates of Hypoglycemia and Severe Hypoglycemia

Time frame:1-48 hours

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

GroupValue (number), participants95% CI
ExenatidePatients with at least one hypoglycemic episode4
Patients with at least one severe episode0
ModeratePatients with at least one hypoglycemic episode14
Patients with at least one severe episode2
IntensivePatients with at least one hypoglycemic episode22
Patients with at least one severe episode1
Secondary/protocol endpoint

Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)

Time frame:30 days

Serious AEs (any)

composite event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke

Posted result

GroupValue (number), participants95% CI
Exenatide4

Publications (1)

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

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.