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Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

NCT ID: NCT00736229

Last Updated: 2014-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Hyperglycemia Acute Coronary Syndromes Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

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

Interventions

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Exenatide

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

Intervention Type DRUG

Other Intervention Names

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Byetta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role collaborator

Saint Luke's Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven P Marso, MD

Role: PRINCIPAL_INVESTIGATOR

Mid America Heart Institute Saint Luke's Health System

Locations

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Mid America Heart Institute Saint Luke's Health System

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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: 10.4158/EP12196.OR.

Reference Type RESULT
PMID: 23186969 (View on PubMed)

Other Identifiers

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08-206

Identifier Type: -

Identifier Source: org_study_id