NCT00736229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 20, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

August 14, 2008

Results QC Date

June 4, 2013

Last Update Submit

November 19, 2014

Conditions

HyperglycemiaAcute Coronary SyndromesMyocardial Infarction

Keywords

hyperglycemiaacute coronary syndromesmyocardial infarction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Rates of Hypoglycemia and Severe Hypoglycemia

    1-48 hours

  • Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)

    30 days

Study Arms (1)

Exenatide

EXPERIMENTAL

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

Drug: Exenatide

Interventions

ExenatideDRUG

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

Also known as: Byetta
Exenatide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid America Heart Institute Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Location

Related 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: 10.4158/EP12196.OR.

    PMID: 23186969RESULT

MeSH Terms

Conditions

HyperglycemiaAcute Coronary SyndromeMyocardial Infarction

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Limitations and Caveats

Modest number of patients enrolled, not powered to examine the effects of exenatide on hard clinical outcomes, no randomization, differences in baseline glucose levels and duration of therapy.

Results Point of Contact

Title
Steven P. Marso, MD
Organization
Saint Luke's Health System
smarso@saint-lukes.org
816-932-5773

Study Officials

  • Steven P Marso, MD

    Mid America Heart Institute Saint Luke's Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

August 1, 2012

Last Updated

November 20, 2014

Results First Posted

November 20, 2014

Record last verified: 2014-11

Locations

US(1)