Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736229
• Other study ID #: 08-206
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2008
• Last updated: November 19, 2014
• Start date: August 2008
• Est. completion date: August 2012

Study information

• Verified date: November 2014
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Hyperglycemia
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	Mid America Heart Institute Saint Luke's Health System	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.415 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)		30 days	Yes