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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

NCTNCT00736229 (opens ClinicalTrials.gov in a new tab)Other id08-206
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Saint Luke's Health System · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2008
Primary completion
Jun 2011
Completion
Aug 2012
First posted
15 Aug 2008 (estimated)
Last update posted
20 Nov 2014 (estimated)
Conditions
Hyperglycemia · Acute Coronary Syndromes · Myocardial Infarction

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 4

    Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

    NCT00736229

    Aug 2008 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ExenatideDrug

Arms1

  • Experimental

    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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Median Glucose Values From Steady State Through 48 Hours or Until Discharge.

    Time frame · 1-48 hours

    Registry description

    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.

  2. Time to Steady State

    Time frame · Start of infusion through 48 hours or until discharge

    Registry description

    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.

Secondary outcomes(2)

  1. Rates of Hypoglycemia and Severe Hypoglycemia

    Time frame · 1-48 hours

    Registry description

    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)

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

    Time frame · 30 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 1-48 hours

Median Glucose Values From Steady State Through 48 Hours or Until Discharge.

GroupValue (mg/dL)
Exenatide132
Moderate127
Intensive105
Primary outcomeMedian· Start of infusion through 48 hours or until discharge

Time to Steady State

GroupValue (hours)
Exenatide2.0
Moderate12.0
Intensive3.0
Secondary and other outcome results(2)
Secondary outcomeNumber· 1-48 hours

Rates of Hypoglycemia and Severe Hypoglycemia

GroupValue (participants)
Exenatide4
Moderate14
Intensive22
Secondary outcomeNumber· 30 days

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

GroupValue (participants)
Exenatide4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ExenatidePatients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.–4 / 406 / 40

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2013

8 results

Management of hyperglycemia with the administration of intravenous exenatide to patients in the cardiac intensive care unit.

Abuannadi et al. 2013Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 38

PMID 23186969DOI 10.4158/ep12196.orPUB-23186969

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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