Back to resultsIntravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
Primary Purpose
Hyperglycemia, Acute Coronary Syndromes, Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring hyperglycemia, acute coronary syndromes, myocardial infarction
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 < 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
Sites / Locations
- Mid America Heart Institute Saint Luke's Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exenatide
Arm Description
0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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)
Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)
Full Information
NCT ID
NCT00736229
First Posted
August 14, 2008
Last Updated
November 19, 2014
Sponsor
Saint Luke's Health System
Collaborators
Amylin Pharmaceuticals, LLC.
1. Study Identification
Unique Protocol Identification Number
NCT00736229
Brief Title
Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
Official Title
Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System
Collaborators
Amylin Pharmaceuticals, LLC.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Acute Coronary Syndromes, Myocardial Infarction
Keywords
hyperglycemia, acute coronary syndromes, myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide
Arm Type
Experimental
Arm Description
0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
Primary Outcome Measure Information:
Title
Median Glucose Values From Steady State Through 48 Hours or Until Discharge.
Description
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 Frame
1-48 hours
Title
Time to Steady State
Description
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.
Time Frame
Start of infusion through 48 hours or until discharge
Secondary Outcome Measure Information:
Title
Rates of Hypoglycemia and Severe Hypoglycemia
Description
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)
Time Frame
1-48 hours
Title
Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Marso, MD
Organizational Affiliation
Mid America Heart Institute Saint Luke's Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid America Heart Institute Saint Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23186969
Citation
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.
Results Reference
result
Learn more about this trial
Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
We'll reach out to this number within 24 hrs