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    Clinical Trial Results:
    Pilot Study with Treatment of Short Bowel Syndrome Patients with end-jejunostomi with the Glucagon-Like Peptide-1 analogue, Liraglutide (Victoza®)

    Summary
    EudraCT number
    		 2013-005499-16
    Trial protocol
    		 DK  
    Global end of trial date
    20 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions
    Summary report(s)
    		 manuscript
    supplementary material

    Trial information

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    Trial identification
    Sponsor protocol code
    2013-624
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Inge Lehmanns Vej 7, Copenhagen, Denmark, 2100
    Public contact
    Palle Bekker Jeppesen, Department of Intestinal Failure and LIver Diseases, clinic 2101, +45 20481323, bekker@dadlnet.dk
    Scientific contact
    Palle Bekker Jeppesen, Department of Intestinal Failure and LIver Diseases, clinic 2101, +45 20481323, bekker@dadlnet.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
    02 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial is to assessthe therapeutic effect of the glucagon-like peptide-1 analogue, liraglutide (Victoza®) for SBS patients with an end-jejunostomi. The efficacy is assessed through the ability of liraglutide (Victoza®) to increase intestinal absorption, reduce diarrhea and the need for hyperphagia, and determine if liraglutide (Victoza®) can reduce the need for parenteral support.
    Protection of trial subjects
    Several safety parameters were done during the trial period, including a physical examination, electrocardiography, vital signs, local tolerability and blood samples.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2014
    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
    Denmark: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    3
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Dates of recruitment: from 3rd February 2014 to 17th March 2014. Recruitment was done through the out-patient clinic database at Department of Intestinal Failure and Liver Diseases, clinic 2101, Inge Lehmanns Vej 7, DK-2100 Copenhagen, Denmark

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 8
    Number of subjects completed
    		 8

    Period 1
    Period 1 title
    Change after 8 weeks treatment
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 8 weeks on liraglutide treatment
    Arm description
    		 All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Uptitration to 1.8 mg/day, subcutanous injections

    Number of subjects in period 1
    		8 weeks on liraglutide treatment
    Started
    8
    Completed
    8
    Period 2
    Period 2 title
    Baseline
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 8 weeks on liraglutide treatment
    Arm description
    		 All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Uptitration to 1.8 mg/day, subcutanous injections

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the baseline period
    Number of subjects in period 2
    		8 weeks on liraglutide treatment
    Started
    8
    Completed
    8

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 5 5
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 63 ± 11 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 5 5
    Wet weight dietary intake
    Measured by 72-hour metabolic balance study
    Units: kg/day
        arithmetic mean (standard deviation)
    		 2.7 ± 0.8 -
    Wet Weight Ostomy Output
    Measured from 72-hour metabolic balance study
    Units: kg/day
        arithmetic mean (standard deviation)
    		 3.2 ± 1.4 -
    Parenteral support volume
    Measured from 72-hour metabolic balance study
    Units: L/day
        arithmetic mean (standard deviation)
    		 3.3 ± 2.2 -
    Energy dietary intake
    Measured from 72-hour metabolic balance study
    Units: kJ/day
        arithmetic mean (standard deviation)
    		 10147 ± 2584 -
    Energy ostomy output
    Measured from 72-hour metabolic balance study
    Units: kJ/day
        arithmetic mean (standard deviation)
    		 6904 ± 3390 -
    Energy parenteral intake
    Units: kJ/day
        arithmetic mean (standard deviation)
    		 4375 ± 2936 -
    Urine output
    Measured from 72-hour metabolic balance study
    Units: L/day
        arithmetic mean (standard deviation)
    		 1543 ± 532 -

    End points

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    End points reporting groups
    Reporting group title
    8 weeks on liraglutide treatment
    Reporting group description
    		 All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values.
    Reporting group title
    8 weeks on liraglutide treatment
    Reporting group description
    		 All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values.

    Primary: Change in wet weight ostomy output

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    End point title
    		 Change in wet weight ostomy output [1]
    End point description
    End point type
    Primary
    End point timeframe
    After 8 weeks of treament
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: system wont allow posting
    End point values
    		 8 weeks on liraglutide treatment
    Number of subjects analysed
    8
    Units: g/day
        arithmetic mean (standard deviation)
    -474 ± 563
    No statistical analyses for this end point

    Secondary: Change in wet weight dietary intake

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    End point title
    		 Change in wet weight dietary intake
    End point description
    End point type
    Secondary
    End point timeframe
    After 8 weeks of treatment
    End point values
    		 8 weeks on liraglutide treatment
    Number of subjects analysed
    8
    Units: g/day
        arithmetic mean (standard deviation)
    9 ± 57
    No statistical analyses for this end point

    Secondary: Urine volume

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    End point title
    		 Urine volume
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline after 8 weeks of treament
    End point values
    		 8 weeks on liraglutide treatment
    Number of subjects analysed
    8
    Units: g/day
        arithmetic mean (standard deviation)
    765 ± 759
    No statistical analyses for this end point

    Secondary: Wet weight absorption

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    End point title
    		 Wet weight absorption
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline after 8 weeks of treatment
    End point values
    		 8 weeks on liraglutide treatment
    Number of subjects analysed
    8
    Units: g/day
        arithmetic mean (standard deviation)
    464 ± 557
    No statistical analyses for this end point

    Secondary: Instestinal energy absorption

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    End point title
    		 Instestinal energy absorption
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline after 8 weeks of treatment
    End point values
    		 8 weeks on liraglutide treatment
    Number of subjects analysed
    8
    Units: kJ/day
        arithmetic mean (standard deviation)
    902 ± 882
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    8 weeks treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    After 8 weeks of treatment
    Reporting group description
    		 -

    Serious adverse events
    		 After 8 weeks of treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 After 8 weeks of treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    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: system wont allow posting

    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
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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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