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Completed

NCT Number: NCT00736229

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.

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Key information

Conditions

Hyperglycemia Acute Coronary Syndrome Acute Coronary Syndromes Cardiovascular Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mid America Heart Institute Saint Luke's Health System

Kansas City, Missouri, 64111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Byetta

Primary outcomes

  1. Median Glucose Values From Steady State Through 48 Hours or Until Discharge.

    Time frame: 1-48 hours

    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.

  2. Time to Steady State

    Time frame: Start of infusion through 48 hours or until discharge

    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 outcomes

  1. Rates of Hypoglycemia and Severe Hypoglycemia

    Time frame: 1-48 hours

    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)

  2. Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Aug 15, 2008
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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