Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.

Detailed Description
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Diabetic patients with acute myocardial infarction (MI) have particularly poor outcomes. Clinical practice guidelines from the American College of Cardiology/American Heart Association for the treatment of patients with acute coronary syndromes call for treatment to achieve preprandial glucose <110 mg/dL, a maximum daily target <180 mg/dL, and a post-discharge hemoglobin A1c <7%. Initiation of aggressive insulin therapy is also warranted to achieve blood glucose <150 mg/dL during days 0-3 and 80-110 mg/dL when possible thereafter. To date, no studies have been conducted assessing the efficacy of intravenous exenatide administration on achieving glucose lowering in hyperglycemic coronary ICU patients.

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

Conditions
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Hyperglycemia, Acute Coronary Syndromes, Myocardial Infarction

Intervention / Treatment
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* Drug: Exenatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br>0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours | Drug: Exenatide<br>* 0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours<br>* Other names: Byetta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Glucose Values From Steady State Through 48 Hours or Until Discharge. | Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge. | 1-48 hours | 
| Time to Steady State | Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl. | Start of infusion through 48 hours or until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Hypoglycemia and Severe Hypoglycemia | Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl) | 1-48 hours | 
| Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperglycemia, acute coronary syndromes, myocardial infarction