Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

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

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

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Myocardial Infarction; Acute Coronary Syndromes
• Intervention / Treatment: Drug: Exenatide

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid America Heart Institute Saint Luke's Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exenatide; 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; 0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours; Other Names: Byetta

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Luke's Health System
• Collaborators: Amylin Pharmaceuticals, LLC.
• Investigators: Principal Investigator: Steven P Marso, MD, Mid America Heart Institute Saint Luke's Health System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 14, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: myocardial infarction; hyperglycemia; acute coronary syndromes
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Myocardial Infarction; Hyperglycemia; Infarction; Acute Coronary Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: 08-206