Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.
Acute Coronary Syndromes
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit|
- Median Glucose Values From Steady State Through 48 Hours or Until Discharge. [ Time Frame: 1-48 hours ] [ Designated as safety issue: No ]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.
- Time to Steady State [ Time Frame: Start of infusion through 48 hours or until discharge ] [ Designated as safety issue: No ]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.
- Rates of Hypoglycemia and Severe Hypoglycemia [ Time Frame: 1-48 hours ] [ Designated as safety issue: Yes ]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)
- Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
Other Name: Byetta
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736229
|United States, Missouri|
|Mid America Heart Institute Saint Luke's Health System|
|Kansas City, Missouri, United States, 64111|
|Principal Investigator:||Steven P Marso, MD||Mid America Heart Institute Saint Luke's Health System|