Phase 4
N=195
Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
Hyperglycemia · Acute Coronary Syndromes · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00736229 ↗Enrolled (actual)
195
Serious AEs
10.0%
Results posted
Nov 2014
Primary outcome: Primary: Median Glucose Values From Steady State Through 48 Hours or Until Discharge. — 132; 127; 105 mg/dL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exenatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Saint Luke's Health System
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Glucose Values From Steady State Through 48 Hours or Until Discharge. |
132; 127; 105 | <0.001 sig |
| PRIMARY Time to Steady State |
2.0; 12.0; 3.0 | <0.001 sig |
| SECONDARY Rates of Hypoglycemia and Severe Hypoglycemia |
4; 14; 22; 0; 2; 1 | — |
| SECONDARY Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days) |
4 | — |
Summary
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00736229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.