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| Name | Class |
|---|---|
| Amylin Pharmaceuticals, LLC. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | 0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | 0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven P Marso, MD | Mid America Heart Institute Saint Luke's Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid America Heart Institute Saint Luke's Health System | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23186969 | Result | Abuannadi M, Kosiborod M, Riggs L, House JA, Hamburg MS, Kennedy KF, Marso SP. Management of hyperglycemia with the administration of intravenous exenatide to patients in the cardiac intensive care unit. Endocr Pract. 2013 Jan-Feb;19(1):81-90. doi: 10.4158/EP12196.OR. |
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All glucose lowering medications were discontinued prior to infusion of exenatide to study the relation between exenatide and blood glucose.
Recruitment start: October 2008 Enrollment complete: June 2010 Recruitment location: Coronary Intensive Care Unit at Saint Luke's Hospital of Kansas City All eligible patients providing informed consent were assigned to a single group: exenatide infusion
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide | Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion. |
| FG001 | Moderate | In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. |
| FG002 | Intensive | In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide | Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion. |
| BG001 | Moderate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat | Posted | Median | Inter-Quartile Range | mg/dL | 1-48 hours |
|
Until hospital discharge or a maximum of 48 hrs, whichever was shorter.
Patients were continually monitored from study drug start until discharge to collect serious and other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide | Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
Modest number of patients enrolled, not powered to examine the effects of exenatide on hard clinical outcomes, no randomization, differences in baseline glucose levels and duration of therapy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven P. Marso, MD | Saint Luke's Health System | 816-932-5773 | smarso@saint-lukes.org |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| 30 days |
In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. |
| BG002 | Intensive | In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Moderate |
In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board. |
| OG002 | Intensive | In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | hours | Start of infusion through 48 hours or until discharge |
|
|
|
|
| Secondary | 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) | Posted | Number | participants | 1-48 hours |
|
|
|
| Secondary | Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days) | Posted | Number | participants | 30 days |
|
|
|
| 4 |
| 40 |
| 6 |
| 40 |
| Stroke | Vascular disorders | Systematic Assessment |
|
| Drug failure | Metabolism and nutrition disorders | Systematic Assessment | If at anytime after 6 hours of study drug administration there are four consecutive fingerstick glucose levels greater than 200 mg/dL the nurse caring for participant will classify drug failure. |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| Wilcoxon (Mann-Whitney) |
| 0.80 |
| No |
| Superiority or Other |
| Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests. | Wilcoxon (Mann-Whitney) | <0.001 | No | Superiority or Other |
|