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    Clinical Trial Results:
    Prevention of metabolic complications of glucocorticoid excess

    Summary
    EudraCT number
    		 2008-005708-18
    Trial protocol
    		 GB  
    Global end of trial date
    24 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions
    Summary report(s)
    		 Adverse event deatils

    Trial information

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    Trial identification
    Sponsor protocol code
    14081962
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01319994
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Queen Mary University
    Sponsor organisation address
    5 Walden St, London, United Kingdom, E1 2EF
    Public contact
    Marie-Claire Rickard, Queen Mary University, m.rickard@qmul.ac.uk
    Scientific contact
    Marie-Claire Rickard, Queen Mary University, m.rickard@qmul.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
    24 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This proposal aims to prevent or treat the deleterious metabolic consequences of glucocorticoids in patients with glucocorticoid excess
    Protection of trial subjects
    Adverse events reporting and monitoring as per the agreed protocol, our sponsor, and the trial steering committee.
    Background therapy
    		 Patients received glucocorticoid treatment as per the treating physicians.
    Evidence for comparator
    		 Comparing the effect of Metformin 850mg TDS to placebo.
    Actual start date of recruitment
    12 Jul 2012
    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
    United Kingdom: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    52
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects initiated on glucocorticoid treatment at the same time as the trial treatment were recruited into the "Prevention algorithm". Subjects already on established glucocorticoids were recruited into the "Treatment algorithm". The recruitment into the "Prevention algorithm" ended up not feasible and not analysed.

    Pre-assignment
    Screening details
    		 patients on glucocorticoid treatment

    Pre-assignment period milestones
    Number of subjects started
    		 53 [1]
    Number of subjects completed
    		 53

    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: this inconsistency is due to withdraws prior to commencing treatment
    Period 1
    Period 1 title
    Overall trial ("Treatment algorithm") (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention ("Treatment algorithm")
    Arm description
    		 Metformin 850mg TDS
    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
    Period of titration aiming for 850mg TDS

    Arm title
    		 Placebo ("Treatment algorithm")
    Arm description
    		 Patients on established glucocorticoids who received placebo during the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets 850mg TDS (titrated as per protocol)

    Number of subjects in period 1 [2]
    		Intervention ("Treatment algorithm") Placebo ("Treatment algorithm")
    Started
    26
    27
    Completed
    19
    21
    Not completed
    7
    6
         Protocol deviation
    7
    6
    Notes
    [2] - 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: this inconsistency is due to withdraws prior to commencing treatment

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention ("Treatment algorithm")
    Reporting group description
    		 Metformin 850mg TDS

    Reporting group title
    Placebo ("Treatment algorithm")
    Reporting group description
    		 Patients on established glucocorticoids who received placebo during the study.

    Reporting group values
    		 Intervention ("Treatment algorithm") Placebo ("Treatment algorithm") Total
    Number of subjects
    		 26 27 53
    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)
    		 47 ( 15 ) 45 ( 15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 15 29
        Male
    		 12 12 24

    End points

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    End points reporting groups
    Reporting group title
    Intervention ("Treatment algorithm")
    Reporting group description
    		 Metformin 850mg TDS

    Reporting group title
    Placebo ("Treatment algorithm")
    Reporting group description
    		 Patients on established glucocorticoids who received placebo during the study.

    Subject analysis set title
    change in the visceral to subcutaneous fat area ratio
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Comparing the change in the interventional vs placebo treatment arms.

    Primary: Change in the visceral to subcutaneous fat area ratio

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    End point title
    		 Change in the visceral to subcutaneous fat area ratio [1]
    End point description
    Assessed by a computer tomography, the primary outcome was the difference between the treatment groups in the body composition change over 12 weeks.
    End point type
    Primary
    End point timeframe
    12 weeks
    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: No analysis supplied by CI
    End point values
    		 change in the visceral to subcutaneous fat area ratio
    Number of subjects analysed
    40
    Units: ratio
        arithmetic mean (confidence interval 95%)
    0.11 (-0.02 to 0.24)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During a subject's participation in the trial and 30 days following the end of his/her participation.
    Adverse event reporting additional description
    Please see attached document for full AE and SAE listing - due to System error in accepting data.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Intervention ("Treatment algorithm")
    Reporting group description
    		 Metformin 850mg TDS

    Reporting group title
    Placebo ("Treatment algorithm")
    Reporting group description
    		 Patients on established glucocorticoids who received placebo during the study.

    Serious adverse events
    		 Intervention ("Treatment algorithm") Placebo ("Treatment algorithm")
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention ("Treatment algorithm") Placebo ("Treatment algorithm")
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 27 (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: Please see attached document for full AE and SAE list - system unable to accept entered data.

    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
    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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