Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients - Full Text View

Sponsors and Collaborators:	Saint Luke's Health System Amylin Pharmaceuticals, Inc.
Information provided by:	Saint Luke's Health System
ClinicalTrials.gov Identifier:	NCT00736229

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
Acute Coronary Syndromes Hyperglycemia Myocardial Infarction	Drug: Exenatide	Phase IV

MedlinePlus related topics: Heart Attack

Drug Information available for: Exenatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Efficacy Study, Non-Randomized, Open Label, Single Group Assignment, Treatment
Official Title:	Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit

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

Primary Outcome Measures:

Average glucose value during coronary ICU stay [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of hypoglycemic episodes / total number of glucose measurements [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ]
Number of subjects with >1 hypoglycemic episode / total number of subjects [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ]
Serious adverse events (death, life-threatening event, prolonged hospitalization, disability or incapacity, congenital anomaly or birth defect, non-life threatening event) after discontinuation of study drug [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Exenatide: Experimental	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

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 CICU 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

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

Contacts

Contact: Cheryl Rutherford, RN	816-932-2000 ext 6275	cjrutherford@saint-lukes.org
Contact: Kathryn Safley, RN	816-932-2000 ext 9885	ksafley@saint-lukes.org

Locations

United States, Missouri
Mid America Heart Institute Saint Luke's Health System	Recruiting
Kansas City, Missouri, United States, 64111
Contact: Cheryl Rutherford, RN 816-932-2000 ext 6275 cjrutherford@saint-lukes.org
Principal Investigator: Steve Marso, MD

Sponsors and Collaborators

Saint Luke's Health System

Amylin Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Mid America Heart Institute Saint Lukes' Health System ( Steven P. Marso, MD )
Study ID Numbers:	08-206
Study First Received:	August 14, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00736229 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Saint Luke's Health System:

acute coronary syndromes
hyperglycemia
myocardial infarction

Study placed in the following topic categories:

Metabolic Diseases
Heart Diseases
Exenatide
Myocardial Ischemia
Vascular Diseases
Ischemia
Necrosis

Hypoglycemic Agents
Hyperglycemia
Acute Coronary Syndrome
Infarction
Glucose Metabolism Disorders
Myocardial Infarction
Metabolic Disorder

Additional relevant MeSH terms:

Disease
Metabolic Diseases
Heart Diseases
Exenatide
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Ischemia
Pharmacologic Actions
Necrosis

Hypoglycemic Agents
Hyperglycemia
Pathologic Processes
Syndrome
Acute Coronary Syndrome
Cardiovascular Diseases
Infarction
Glucose Metabolism Disorders
Myocardial Infarction

ClinicalTrials.gov processed this record on March 16, 2009