Clinical trial NCT00736229: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Acute Coronary Syndromes
Myocardial Infarction
Keywords: hyperglycemia
acute coronary syndromes
myocardial infarction
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2008-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median Glucose Values From Steady State Through 48 Hours or Until Discharge.
timeFrame: 1-48 hours
measure: Time to Steady State
timeFrame: Start of infusion through 48 hours or until discharge
Secondary outcomes:
measure: Rates of Hypoglycemia and Severe Hypoglycemia
timeFrame: 1-48 hours
measure: Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)
timeFrame: 30 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Mid America Heart Institute Saint Luke's Health System
state: Missouri
Study officials:
affiliation: Mid America Heart Institute Saint Luke's Health System
name: Steven P Marso, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.