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Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT00736229
First received: August 14, 2008
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Hyperglycemia
Acute Coronary Syndromes
Myocardial Infarction
Drug: Exenatide
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Primary Outcome Measures:
  • Median Glucose Values From Steady State Through 48 Hours or Until Discharge. [ Time Frame: 1-48 hours ] [ Designated as safety issue: No ]
    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 Frame: Start of infusion through 48 hours or until discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-48 hours ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: August 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Byetta

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736229

Locations
United States, Missouri
Mid America Heart Institute Saint Luke's Health System
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Saint Luke's Health System
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Steven P Marso, MD Mid America Heart Institute Saint Luke's Health System
  More Information

Publications:
Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT00736229     History of Changes
Other Study ID Numbers: 08-206
Study First Received: August 14, 2008
Results First Received: June 4, 2013
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Luke's Health System:
hyperglycemia
acute coronary syndromes
myocardial infarction

Additional relevant MeSH terms:
Acute Coronary Syndrome
Hyperglycemia
Infarction
Myocardial Infarction
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Glucose Metabolism Disorders
Heart Diseases
Ischemia
Metabolic Diseases
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014