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    Clinical Trial Results:
    The effect of empagliflozin versus metformin on hormonal, metabolic and cardiovascular risk factors in patients with polycystic ovary syndrome (PCOS) – a randomised open-label parallel study.

    Summary
    EudraCT number
    		 2016-004435-20
    Trial protocol
    		 GB  
    Global end of trial date
    16 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2019
    First version publication date
    15 May 2019
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    Version 3, 23.05.17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hull and East Yorkshire Hospitals NHS Trust
    Sponsor organisation address
    Anlaby Road, Hull, United Kingdom, HU3 2JZ
    Public contact
    Professor Thozhukat Sathyapalan, University of Hull, 01482 675312, thozhukat.sathyapalan@hyms.ac.uk
    Scientific contact
    Professor Thozhukat Sathyapalan, University of Hull, 01482 675312, thozhukat.sathyapalan@hyms.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
    31 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does empagliflozin at a dose of 25mg improve enothelial function (cardiovascular risk marker) in women with PCOS?
    Protection of trial subjects
    All women will be instructed to maintain their usual dietary habits and physical activity during the study. No vulnerable subjects or non-English speakers will be recruited. All subjects will be Caucasian as PCOS may differ among ethnic groups. Adverse events will be reported in accordance with HEY R&D department’s Safety Reporting standard operating procedure (R&D GCP SOP 07) to ensure compliance with UK Clinical Trial Regulations; ICH GCP and the Research Governance Framework 2005. The AE reporting period for this trial begins as soon as patients have consented to the trial and ends 30 days after the patients final study medication visit. Black triangle scheme for empagliflozin: All suspected ADRs for empagliflozin will be reported using the Yellow Card scheme These can be reported through the Yellow Card website, https://yellowcard.mhra.gov.uk/ Or, by emailing yellowcard@mhra.gsi.gov.uk Or, by using a yellow card found in the back of the BNF. Development safety update report (DSUR): The PI will provide (in addition to the expedited reporting above) DSURs once a year throughout the clinical trial, or on request, to the Competent Authority (MHRA in the UK), Ethics Committee, Host NHS Trust and Sponsor. The report will be submitted within 60 days of the Developmental International Birth Date (DIBD) or the MHRA clinical trial authorisation of the trial each year until the trial is declared ended. Due to the seriousness of the disease in this study, the following expected SAEs will not require reporting within 24hrs to R&D on the initial and follow-up SAE forms, but will still need to be recorded on R&D’s AE report form.
    Background therapy
    		 -
    Evidence for comparator
    		 The comparator to empagliflozin will be metformin that is used widely to improve insulin sensitivity, reduce androgen levels, may reduce diastolic blood pressure, dyslipidaemia and body mass index (BMI) in patients with PCOS.
    Actual start date of recruitment
    03 Apr 2017
    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: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    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)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with PCOS will be identified from endocrine clinics and will be contacted by a clinician responsible for the patient. Participants, who have agreed to be contacted for potential research opportunities, will also be recruited from a departmental PCOS biobank.

    Pre-assignment
    Screening details
    		 Patients with PCOS will be identified from endocrine clinics and will be contacted by a clinician responsible for the patient.

    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
    		 Empaglifozin
    Arm description
    		 Experimental medicine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Jardiance
    Investigational medicinal product code
    SUB35915
    Other name
    Empaglifozin
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    12 weeks; 25mg per day; oral use

    Arm title
    		 Metformin
    Arm description
    		 Comparator
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glucophage
    Investigational medicinal product code
    SUB03200MIG
    Other name
    Metformin
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Buccal use
    Dosage and administration details
    1500mg per day for 12 weeks.

    Number of subjects in period 1
    		Empaglifozin Metformin
    Started
    19
    20
    Completed
    19
    20

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 39 39
    Age categorical
    Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 39 39
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 0 0
    Ethnic group
    Caucasion only accepted due to nature of study.
    Units: Subjects
        Caucasian
    		 39 39
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The trial will be reported according to CONSORT guidelines [20]. Between-group comparisons will be summarized as a series of ‘effect sizes’ for primary and secondary outcomes, from which numbers needed to plan for a larger trial can be estimated. No subgroup analysis are planned. The Stata statistical computer package will be used to analyse the data.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    39
    Age categorical
    Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria.
    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)
    39
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    39
        Male
    0
    Ethnic group
    Caucasion only accepted due to nature of study.
    Units: Subjects
        Caucasian

    End points

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    End points reporting groups
    Reporting group title
    Empaglifozin
    Reporting group description
    		 Experimental medicine

    Reporting group title
    Metformin
    Reporting group description
    		 Comparator

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The trial will be reported according to CONSORT guidelines [20]. Between-group comparisons will be summarized as a series of ‘effect sizes’ for primary and secondary outcomes, from which numbers needed to plan for a larger trial can be estimated. No subgroup analysis are planned. The Stata statistical computer package will be used to analyse the data.

    Primary: RHI

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    End point title
    		 RHI
    End point description
    Measured by reactive hyperamia index
    End point type
    Primary
    End point timeframe
    12 weeks (recruitment to end of trial visit for patient)
    End point values
    		 Empaglifozin Metformin Full analysis
    Number of subjects analysed
    19
    20
    39
    Units: percent
    19
    20
    39
    Statistical analysis title
    		 Statistical analysis plane
    Statistical analysis description
    The trial will be reported according to CONSORT guidelines [20]. Between-group comparisons will be summarized as a series of ‘effect sizes’ for primary and secondary outcomes, from which numbers needed to plan for a larger trial can be estimated. No subgroup analysis are planned. The Stata statistical computer package will be used to analyse the data
    Comparison groups
    Empaglifozin v Metformin v Full analysis
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≥ 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from consent to 30 days after final visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    non serious AE
    Reporting group description
    		 Headache seen in one patient

    Serious adverse events
    		 non serious AE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 non serious AE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    General disorders and administration site conditions
    Headache
    Additional description: Headache
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    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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