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    Clinical Trial Results:
    A Feasibility study looking at the use of Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS

    Summary
    EudraCT number
    2013-004706-25
    Trial protocol
    GB  
    Global end of trial date
    01 Nov 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jul 2020
    First version publication date
    04 Jul 2020
    Other versions
    Summary report(s)
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    V1290413
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02080377
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    ETHICS: 13/SS/0223 , CSO Funder: CZH/4/10
    Sponsors
    Sponsor organisation name
    University of Edinburgh
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Marise Bucukoglu Head of Research Governance, University of Edinburgh, +44 131 242 6623, marise.bucukoglu@ed.ac.uk
    Scientific contact
    Marise Bucukoglu Head of Research Governance, University of Edinburgh, +44 131 242 6623, marise.bucukoglu@ed.ac.uk
    Sponsor organisation name
    NHS Lothian
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Dr. Heather Charles Head of Research Governance, Professor Jane Norman University of Edinburgh, +44 1312423325, ACCORD@nhslothian.scot.nhs.uk
    Scientific contact
    Dr. Heather Charles Head of Research Governance, Professor Jane Norman University of Edinburgh, +44 1312423325, ACCORD@nhslothian.scot.nhs.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
    30 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of gestational diabetes. Additionally, we will compare glycaemic control in the two groups, and evaluate acceptability. Finally, we will collect information on a range of clinical and biochemical outcomes to inform the design of a large definitive randomised trial. Primary outcome: The number of women who agree to be randomised.
    Protection of trial subjects
    The trial steering committee will monitor participants’ glucose readings, paying particular attention to number and frequency of episodes of hypoglycaemia. If it is deemed that there are too many incidences of hypoglycaemia in the intervention arm then the intervention could be withdrawn and the trial stopped prematurely.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Aug 2014
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were given verbal and written information about the study at the time of diagnosis of GDM. Prior to recruitment, treatment with metformin was commenced if women were failing to achieve adequate glycaemic control with lifestyle measures alone, according to standard practice.

    Pre-assignment
    Screening details
    All women with GDM attending the selected sites who fail monotherapy and do not meet any of the exclusion criteria will be considered to be eligible

    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
    Glibenclamide
    Arm description
    The primary aim of this feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of gestational diabetes mellitus. Secondary aims will be to compare glycaemic control in the two groups, evaluate acceptability and to collect information on a range of clinical outcomes to inform the design of a large definitive randomised trial.
    Arm type
    Active comparator

    Investigational medicinal product name
    Glibenclamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    glibenclamide in either a 2.5 mg or 5 mg tablet. The usual dosage of glyburide is 2.5–20 mg daily in divided doses, although pharmacokinetic studies during pregnancy indicate daily doses up to 30 mg may be necessary to achieve adequate control” [15,16]. Of note, none of the six referees of the grant application related to this protocol have commented adversely on the dose of glibenclamide (reports available on request). The dose will alter according to the clinician’s recommendations, following a strict dosing algorithm drawn up prior to the study commencing

    Arm title
    Insulin
    Arm description
    -
    Arm type
    Standard Care

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    AS required

    Number of subjects in period 1
    Glibenclamide Insulin
    Started
    13
    10
    Completed
    13
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Glibenclamide
    Reporting group description
    The primary aim of this feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of gestational diabetes mellitus. Secondary aims will be to compare glycaemic control in the two groups, evaluate acceptability and to collect information on a range of clinical outcomes to inform the design of a large definitive randomised trial.

    Reporting group title
    Insulin
    Reporting group description
    -

    Reporting group values
    Glibenclamide Insulin Total
    Number of subjects
    13 10 23
    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)
    33.0 ± 5.1 34.5 ± 4.9 -
    Gender categorical
    Units: Subjects
        Female
    13 10 23
        Male
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Glibenclamide
    Reporting group description
    The primary aim of this feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of gestational diabetes mellitus. Secondary aims will be to compare glycaemic control in the two groups, evaluate acceptability and to collect information on a range of clinical outcomes to inform the design of a large definitive randomised trial.

    Reporting group title
    Insulin
    Reporting group description
    -

    Primary: Number of women Randomised

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    End point title
    Number of women Randomised
    End point description
    The primary endpoint is the number (and corresponding throughput) of women who agree to be randomised
    End point type
    Primary
    End point timeframe
    Randomisation
    End point values
    Glibenclamide Insulin
    Number of subjects analysed
    13
    10
    Units: not applicable
    13
    10
    Statistical analysis title
    Number of women agreed to randomisation
    Comparison groups
    Glibenclamide v Insulin
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.05 [2]
    Method
    Poisson distribution
    Confidence interval
    Notes
    [1] - Feasability
    [2] - As this was a feasibility study a formal power calculation was not considered appropriate

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AEs and SAEs will be recorded from the time a participant signs the consent form to take part in the study until stopping the IMP or discharge following delivery of the baby, whichever is later
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: All adverse medical events reported by the participant were noted in the participant’s hospital notes, together with a note of the date of starting, the duration, and any medical treatment received. The clinician will assess ALL reported AEs.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2014
    Increased detail, changes to flow chart, change in secondary outcomes, NIMP and Imp supply, clarification on rand process, stats analysis and TSC/DMC details
    17 Dec 2014
    Lower limit of gestation (weeks) from 20+0 weeks gestation to 16+0 weeks gestation. It also includes some minor clarifications in the protocol, consent form and PIL, as well as the opening of recruitment in another hospital

    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.
    The limitations of the study include the small sample size, which could have contributed to a chance imbalance on prognostic factors including weight and time of diagnosis.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28938877
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