Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Saint Luke's Health System

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia; Acute Coronary Syndromes; Myocardial Infarction

Treatments: Drug: Exenatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00736229

08-206

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Exenatide

Experimental group

Description:

0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours

Treatment:

Drug: Exenatide