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    Clinical Trial Results:
    Randomised controlled trial of Gestational treatment with Ursodeoxycholic Acid compared to Metformin to Reduce effects of Diabetes mellitus

    Summary
    EudraCT number
    		 2019-002880-82
    Trial protocol
    		 GB  
    Global end of trial date
    12 Aug 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Aug 2026
    First version publication date
    20 Aug 2026
    Other versions
    Summary report(s)
    		 GUARD CSR 24Jul26

    Trial information

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    Trial identification
    Sponsor protocol code
    GUARD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King’s College London
    Sponsor organisation address
    KHPCTO F16, Guys Hospital, London, United Kingdom, SE1 9RT
    Public contact
    Professor Catherine Williamson, King’s College London, +44 020 7848 6350, catherine.williamson@kcl.ac.uk
    Scientific contact
    Professor Catherine Williamson, King’s College London, +44 020 7848 6350 , catherine.williamson@kcl.ac.uk
    Sponsor organisation name
    Guy’s and St Thomas NHS Foundation Trust
    Sponsor organisation address
    KHPCTO F16, Guys Hospital, London, United Kingdom, SE1 9RT
    Public contact
    Professor Catherine Williamson, Guy’s and St Thomas NHS Foundation Trust, +44 020 7848 6350, amy.holton@kcl.ac.uk
    Scientific contact
    Professor Catherine Williamson, Guy’s and St Thomas NHS Foundation Trust, +44 020 7848 6350, amy.holton@kcl.ac.uk
    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
    29 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We would like to assess how well ursodeoxycholic acid works at controlling glucose levels in overweight or obese women with gestational diabetes mellitus, compared to metformin, which is the most commonly used treatment.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. Trial committees (IDMC and TSC) will be appointed to oversee the conduct of the study. Monitoring to ensure compliance with Good Clinical Practice and scientific integrity will be managed and oversight retained by the KHP-CTO Quality Team.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2020
    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
    United Kingdom: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    3
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    55
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 58
    Number of subjects completed
    		 51

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Intolerance to study medication: 1
    Reason: Number of subjects
    		 Declined further blood sampling: 1
    Reason: Number of subjects
    		 Cannulation unsuccessful: 2
    Reason: Number of subjects
    		 Vasovagal episode following initial blood sampling: 1
    Reason: Number of subjects
    		 Gave birth abroad; did not return for follow-up: 1
    Reason: Number of subjects
    		 Did not attend study visit: 1
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GDM taking metformin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin dose escalation scheme as per their standard of care

    Arm title
    		 GDM managed with lifestyle only
    Arm description
    		 -
    Arm type
    		 No active

    Investigational medicinal product name
    Ursodeoxycholic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500mg BD

    Arm title
    		 No GDM (control)
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		GDM taking metformin GDM managed with lifestyle only No GDM (control)
    Started
    10
    22
    19
    Completed
    8
    21
    16
    Not completed
    2
    1
    3
         Lost to follow-up
    -
    1
    -
         Withdrew before first sample
    -
    -
    2
         Withdrew after fasting sample
    2
    -
    -
         Did not attend study day
    -
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: we do not count screening participants as enrolled

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GDM taking metformin
    Reporting group description
    		 -

    Reporting group title
    GDM managed with lifestyle only
    Reporting group description
    		 -

    Reporting group title
    No GDM (control)
    Reporting group description
    		 -

    Reporting group values
    		 GDM taking metformin GDM managed with lifestyle only No GDM (control) Total
    Number of subjects
    		 10 22 19 51
    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
        median (inter-quartile range (Q1-Q3))
    		 37 (33 to 39) 33 (32 to 37) 35 (31 to 37) -
    Gender categorical
    Units: Subjects
        Female
    		 10 22 19 51
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    GDM taking metformin
    Reporting group description
    		 -

    Reporting group title
    GDM managed with lifestyle only
    Reporting group description
    		 -

    Reporting group title
    No GDM (control)
    Reporting group description
    		 -

    Primary: Hba1c

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    End point title
    		 Hba1c [1]
    End point description
    The study was ceased before sufficient participants were recruited for meaningful analysis, the decision was made not to analyse data from GUARD IMP-receiving participants from the main study. Therefore, no primary outcome data were compared.
    End point type
    Primary
    End point timeframe
    Baseline
    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: Please see uploaded report
    End point values
    		 GDM taking metformin GDM managed with lifestyle only No GDM (control)
    Number of subjects analysed
    10
    22
    16
    Units: mmol/mol
        median (inter-quartile range (Q1-Q3))
    36.5 (33.0 to 43.3)
    35.0 (29.0 to 36.0)
    32.0 (30 to 33.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    baseline to 32 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    GDM taking metformin
    Reporting group description
    		 -

    Reporting group title
    GDM managed with lifestyle only
    Reporting group description
    		 -

    Serious adverse events
    		 GDM taking metformin GDM managed with lifestyle only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Pre-eclampsia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GDM taking metformin GDM managed with lifestyle only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 21 (4.76%)
    Pregnancy, puerperium and perinatal conditions
    Pre-eclampsia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2020
    SA01 - PIS-ICF v2.0 29JUL20, Summary PIS v2.0 30OCT20, Stool collection instructions v2.0 26OCT20 and Payment of Compensation form
    24 May 2021
    SA02 - Informing the competent authority of the outcome of the CI’s assessment and decision that COVID-19 vaccine given to a trial participant is considered as a simple concomitant medication with no interaction that requires advice on timing of the vaccine or other aspects.
    29 Mar 2022
    SA03 - Protocol V4.0 21Oct21, PIS ICF V2.2 21Oct21, GUARD MECV 2.0 21Oct21, Summary PIS V3.0 21Oct21, Patient poster V1.0 21Oct21, GUARD website contents V1.0 21Oct21
    07 Jun 2022
    SA04 - Protocol V5.0 22Mar22, PIS ICF V2.3 22Mar22, GUARD MEC V2.1 22Mar22, Summary PIS V3.1 22Mar22
    19 Apr 2023
    SA05 - Notification to the REC of halting recruitment to the CTIMP arms of the GUARD trial.
    06 Oct 2023
    SA06 - Protocol V5.1 11Oct23, Caroline Ovadia Research CV, Caroline Ovadia GCP certificate
    14 Aug 2024
    SA07 - Protocol V6.0 08July2024, PIS ICF V2.2 13Mar24

    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
    For support, Contact us.
    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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