Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Phase 4

Completed

• Conditions: Hyperglycemia; Acute Coronary Syndromes; Myocardial Infarction
• Interventions: Drug: Exenatide

• Registration Number: NCT00736229
• Lead Sponsor: Saint Luke's Health System

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2011-06
• Study Completion: 2012-08
• Results First Submitted: 2013-06-04
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Results First Posted: 2014-11-20
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exenatide	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

Primary Outcome Measures

Name	Time	Method
Median Glucose Values From Steady State Through 48 Hours or Until Discharge.	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.
Time to Steady State	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 Outcome Measures

Name	Time	Method
Rates of Hypoglycemia and Severe Hypoglycemia	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)
Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)	30 days

Trial Locations

Locations (1)

Mid America Heart Institute Saint Luke's Health System; 🇺🇸 Kansas City, Missouri, United States