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    Clinical Trial Results:
    The effect of Exenatide on brown adipose tissue activity and energy expenditure in healthy young men

    Summary
    EudraCT number
    2016-000238-23
    Trial protocol
    NL  
    Global end of trial date
    30 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Feb 2020
    First version publication date
    21 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ExeBAT01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03002675
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Leiden University Medical Center
    Sponsor organisation address
    Albinusdreef 2, Leiden, Netherlands, 2333ZA
    Public contact
    Clinical trial information, Leiden University Medical Center, l.g.m.janssen@lumc.nl
    Scientific contact
    Clinical trial information, Leiden University Medical Center, l.g.m.janssen@lumc.nl
    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
    30 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of Exenatide treatment on BAT activity and energy expenditure in healthy young subjects of South Asain and white Caucasian descent
    Protection of trial subjects
    NA
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Sep 2016
    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: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Inclusion Criteria - Dutch South Asian or white Caucasian male, 20-36 years - BMI ≥ 18 and ≤ 27 kg/m2 - Good general health

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    exenatide
    Arm description
    -
    Arm type
    exenatide

    Investigational medicinal product name
    exenatide (Bydureon)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2mg

    Number of subjects in period 1
    exenatide
    Started
    24
    Completed
    24
    Period 2
    Period 2 title
    after exenatide
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    exenatide
    Arm description
    -
    Arm type
    exenatide

    Investigational medicinal product name
    exenatide (Bydureon)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2mg

    Number of subjects in period 2
    exenatide
    Started
    24
    Completed
    24

    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
    24 24
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.5 ± 0.7 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    24 24

    End points

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

    Primary: energy expenditure

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    End point title
    energy expenditure
    End point description
    End point type
    Primary
    End point timeframe
    after 12 weeks exenatide treatment
    End point values
    exenatide exenatide
    Number of subjects analysed
    24
    24
    Units: kcal/day
        number (not applicable)
    24
    24
    Attachments
    Untitled (Filename: 20200204 eudract_exe_calorimetry.pdf)
    Statistical analysis title
    exenatide_calorimetry
    Comparison groups
    exenatide v exenatide
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    > 0.05
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -102
         upper limit
    15
    Notes
    [1] - Data were analysed by linear mixed models and are presented as mean±SEM.

    Primary: bat fdg uptake

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    End point title
    bat fdg uptake
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks exenatide
    End point values
    exenatide exenatide
    Number of subjects analysed
    24
    24
    Units: NA
    24
    24
    Attachments
    Untitled (Filename: 20200204 eudract_exe_bat_pet.pdf)
    Statistical analysis title
    fdg uptake bat
    Comparison groups
    exenatide v exenatide
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.05
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.84
         upper limit
    42

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks exenatide
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    total study population
    Reporting group description
    -

    Serious adverse events
    total study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    total study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 24 (75.00%)
    Nervous system disorders
    Dizziness
    Additional description: Flu-like symptoms, fatigue, asthenia, headache, dizziness
         subjects affected / exposed
    6 / 24 (25.00%)
         occurrences all number
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 24 (50.00%)
         occurrences all number
    12
    Dyspepsia
    Additional description: obstipation, diarrhea, dyspepsia, abdominal distention, reflux
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    subcutaneous infiltrate
         subjects affected / exposed
    18 / 24 (75.00%)
         occurrences all number
    18
    Erythema
    Additional description: erythema, rash, pruritus, hematoma
         subjects affected / exposed
    6 / 24 (25.00%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2016
    adjust cooling protocol
    26 Jan 2017
    add questionnaires
    24 Aug 2017
    expand bmi and age inclusion criteria

    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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