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    Clinical Trial Results:
    GLP-1 for bridging of hyperglycaemia during cardiac surgery: a randomized controlled trial

    Summary
    EudraCT number
    		 2017-000043-40
    Trial protocol
    		 NL  
    Global end of trial date
    30 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2021
    First version publication date
    17 Dec 2021
    Other versions
    Summary report(s)
    		 GLOBE trail results

    Trial information

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    Trial identification
    Sponsor protocol code
    GLOBE2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1183-2689
    Other trial identifiers
    		 UTN register: U1111-1183-2689, CCMO number: NL60461.018.17, Nederlands Trial Register: NTR6323
    Sponsors
    Sponsor organisation name
    AMC
    Sponsor organisation address
    Meibergdreef 9, Amsterdam, Netherlands, 1105 AZ
    Public contact
    Dr. J. Hermanides, Academic Medical Center, 0031 0205669111,
    Scientific contact
    Dr. J. Hermanides, Academic Medical Center, 0031 0205669111,
    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
    01 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    the primary objective of this study is to investigate the potential of liraglutide to lower the proportion of patients needing insulin therapy during cardiac surgery when aiming for a perioperative plasma glucose of <8 mmol l-1.
    Protection of trial subjects
    Ondansetron given to all subjects to prevent nausea and vomiting
    Background therapy
    		 Insulin for management of hyperglycaemia
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 278
    Worldwide total number of subjects
    278
    EEA total number of subjects
    278
    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)
    145
    From 65 to 84 years
    133
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1014 screened

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.6-1.2

    Arm title
    		 Liraglutide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,6 - 1,2 mg

    Number of subjects in period 1
    		Placebo Liraglutide
    Started
    139
    139
    Received 1 dose of study drug
    132
    129
    Completed
    132
    129
    Not completed
    7
    10
         Lost to follow-up
    7
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Liraglutide Total
    Number of subjects
    		 139 139 278
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 73 72 145
        From 65-84 years
    		 66 67 133
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65 ( 11 ) 65 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 26 54
        Male
    		 111 113 224
    Subject analysis sets

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat

    Subject analysis sets values
    		 Final analysis
    Number of subjects
    261
    Age categorical
    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)
    128
        From 65-84 years
    133
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65 ( 11 )
    Gender categorical
    Units: Subjects
        Female
    50
        Male
    211

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat

    Primary: Insulin therapy

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    End point title
    		 Insulin therapy
    End point description
    End point type
    Primary
    End point timeframe
    Perioperative
    End point values
    		 Placebo Liraglutide
    Number of subjects analysed
    132
    129
    Units: patients
        Yes
    80
    55
        No
    52
    74
    Statistical analysis title
    		 Chi square
    Comparison groups
    Placebo v Liraglutide
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 30
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In hospital
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    69 / 132 (52.27%)
    65 / 129 (50.39%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    1
    2
    Cardiac disorders
    Composite cardiac outcome
    Additional description: MI, cardiac death, stroke
         subjects affected / exposed
    58 / 132 (43.94%)
    53 / 129 (41.09%)
         occurrences causally related to treatment / all
    0 / 58
    0 / 53
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Infections and infestations
    Composite infectious complications
    Additional description: Wound infections, pneumonia, UTI or blood infection
         subjects affected / exposed
    11 / 132 (8.33%)
    12 / 129 (9.30%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Product issues
    Nausea and vomiting
         subjects affected / exposed
    29 / 132 (21.97%)
    37 / 129 (28.68%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 37
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 132 (57.58%)
    93 / 129 (72.09%)
    Cardiac disorders
    Arythmia
         subjects affected / exposed
    47 / 132 (35.61%)
    56 / 129 (43.41%)
         occurrences all number
    47
    56
    Product issues
    Nausea and vomiting
         subjects affected / exposed
    29 / 132 (21.97%)
    37 / 129 (28.68%)
         occurrences all number
    29
    37

    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/31749275
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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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