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    Clinical Trial Results:
    GLP-1 ANALOGS FOR NEUROPROTECTION AFTER OUT-OF-HOSPITAL CARDIAC ARREST, A RANDOMIZED CLINICAL TRIAL

    Summary
    EudraCT number
    		 2013-004311-45
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2021
    First version publication date
    30 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013-PharmaCA-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital Rigshospitalet
    Sponsor organisation address
    9 Blegdamsvej, Copenhagen, Denmark, 2100
    Public contact
    Cardiology Intensive Care Unit B214, Copenhagen University Hospital Rigshospitalet, Department of Cardiology B 2143, 45 35452143, jesper.kjaergaard.01@regionh.dk
    Scientific contact
    Cardiology Intensive Care Unit B214, Copenhagen University Hospital Rigshospitalet, Department of Cardiology B 2143, 45 35452143, jesper.kjaergaard.01@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To reduce to degree of post anoxic brain injury following resuscitation cardiac arrest, defined by a combined endpoint of efficacy (area under the Neuron Specific Enolasis -curve) and a feasibility defined as rapid initiation of study drug infusion
    Protection of trial subjects
    Was applied according to the protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    80
    85 years and over
    20

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment finalaized

    Pre-assignment
    Screening details
    		 Screening patients admitted after resuscitated cardiac arrest

    Pre-assignment period milestones
    Number of subjects started
    		 120
    Number of subjects completed
    		 120

    Period 1
    Period 1 title
    Recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 GLP-1 analoug
    Arm description
    		 Byetta
    Arm type
    		 Experimental

    Investigational medicinal product name
    Byetta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    17.4 mcg of exenatide

    Number of subjects in period 1
    		GLP-1 analoug
    Started
    120
    Completed
    120

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLP-1 analoug
    Reporting group description
    		 Byetta

    Reporting group values
    		 GLP-1 analoug Total
    Number of subjects
    		 120 120
    Age categorical
    Age groups
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 80 80
        85 years and over
    		 20 20
    Age continuous
    Age groups 2
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 11 ) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 22 22
        Male
    		 98 98
    Subject analysis sets

    Subject analysis set title
    final
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Alle subjects

    Subject analysis sets values
    		 final
    Number of subjects
    120
    Age categorical
    Age groups
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    20
        From 65-84 years
    80
        85 years and over
    20
    Age continuous
    Age groups 2
    Units: years
        arithmetic mean (standard deviation)
    60 ( 11 )
    Gender categorical
    Gender
    Units: Subjects
        Female
    22
        Male
    98

    End points

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    End points reporting groups
    Reporting group title
    GLP-1 analoug
    Reporting group description
    		 Byetta

    Subject analysis set title
    final
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Alle subjects

    Primary: Area Under the NSE curve

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    End point title
    		 Area Under the NSE curve
    End point description
    Area under the NSE curve
    End point type
    Primary
    End point timeframe
    48 hours
    End point values
    		 GLP-1 analoug final
    Number of subjects analysed
    118
    118 [1]
    Units: mcg
        number (confidence interval 0%)
    1307 (884 to 2093)
    1307 (884 to 2093)
    Notes
    [1] - Correct
    Statistical analysis title
    		 Primary
    Comparison groups
    GLP-1 analoug v final
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1307
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 804
         upper limit
    		 2093
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CRF
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Done

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27838646
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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