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    Clinical Trial Results:
    Empagliflozin in Post-Transplantation Diabetes Mellitus

    Summary
    EudraCT number
    		 2016-001580-37
    Trial protocol
    		 AT  
    Global end of trial date
    07 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EMPTRA-PTDM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03113110
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090
    Public contact
    Clinical Trials Information, Medical University of Vienna, +43 0140400 55930, manfred.hecking@meduniwien.ac.at
    Scientific contact
    Clinical Trials Information, Medical University of Vienna, +43 0140400 55930, manfred.hecking@meduniwien.ac.at
    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
    05 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether monotherapy with empagliflozin has the same efficacy in controlling hyperglycaemia as standard basal insulin therapy (not succeeding 40 IE/day) in kidney transplanted patients with PTDM, as judged by 2-hour glucose levels during an oral glucose tolerance test (OGTT).
    Protection of trial subjects
    glycemic profiles, regularly monitoring of adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 2017
    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
    Austria: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    12
    From 65 to 84 years
    2
    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
    		 14
    Number of subjects completed
    		 14

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Patients have been switched from stable insulin therapy to SGLT-2 inhbititor
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Empagliflozin
    Investigational medicinal product code
    EMEA/H/C/002677
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg once daily in the morning

    Number of subjects in period 1
    		Treatment
    Started
    14
    Completed
    8
    Not completed
    6
         Adverse event, non-fatal
    6

    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
    		 14 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    We chose the intra‐individual difference in the 2‐hour glucose level between the first OGTT (baseline) and the second OGTT as the primary study end point. We judged an average change of 30 mg/dL to be clinically meaningful, thereby suggesting noninfe‐ riority of the empagliflozin treatment if the 2‐hour blood glucose during the second OGTT did not show an increase of >30 mg/ dL.

    Subject analysis set title
    COntrol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    We chose the intra‐individual difference in the 2‐hour glucose level between the first OGTT (baseline) and the second OGTT as the primary study end point. We judged an average change of 30 mg/dL to be clinically meaningful, thereby suggesting noninfe‐ riority of the empagliflozin treatment if the 2‐hour blood glucose during the second OGTT did not show an increase of >30 mg/ dL.

    Subject analysis sets values
    		 Treatment COntrol
    Number of subjects
    14
    14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    12
    12
        From 65-84 years
    2
    2
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    7
    7
        Male
    7
    7

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Patients have been switched from stable insulin therapy to SGLT-2 inhbititor

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    We chose the intra‐individual difference in the 2‐hour glucose level between the first OGTT (baseline) and the second OGTT as the primary study end point. We judged an average change of 30 mg/dL to be clinically meaningful, thereby suggesting noninfe‐ riority of the empagliflozin treatment if the 2‐hour blood glucose during the second OGTT did not show an increase of >30 mg/ dL.

    Subject analysis set title
    COntrol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    We chose the intra‐individual difference in the 2‐hour glucose level between the first OGTT (baseline) and the second OGTT as the primary study end point. We judged an average change of 30 mg/dL to be clinically meaningful, thereby suggesting noninfe‐ riority of the empagliflozin treatment if the 2‐hour blood glucose during the second OGTT did not show an increase of >30 mg/ dL.

    Primary: 2-hour glucose difference between the first and the second Oral glucose tolerance test

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    End point title
    		 2-hour glucose difference between the first and the second Oral glucose tolerance test
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 Treatment COntrol
    Number of subjects analysed
    14
    14
    Units: mg/dL
        arithmetic mean (standard deviation)
    232 ( 82 )
    273 ( 116 )
    Statistical analysis title
    		 Mean Difference and Standarddeviation
    Statistical analysis description
    We summarized numerical data as means ± standard deviation or me‐ dians with interquartile ranges (IQRs), depending on their distribution. For value comparisons of ordinal and numerical data (primary and sec‐ ondary outcomes), we used the Wilcoxon signed rank test for depend‐ ent samples or the paired Student t test, if data were approximately normally distributed. For nominal parameters, we used the McNemar test for paired samples. A P < .05 was considered statisti‐ cally significant. For calc
    Comparison groups
    Treatment v COntrol
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    17.03.2017-10.05.2017
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    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: There were no serious adverse events
    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 14 (35.71%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Renal and urinary disorders
    Rejection and Drop in GFR
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Respiratory Infection
    Additional description: Respiratory infection required antibiotic treatment and hospitalization
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tuberculosis lymph node
    Additional description: Requirement of 3x tuberculostatic therapy
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jan 2017
    Changes to the protocol with a new Version 6.1. 27.12.2016 - Change in Titel - Change in CRF, including now blood glucose protocol and urinary analysis protocol - Including the collection of a blood sample for Renin Angiotensin System Analysis - Including Body composite measurements (BCM) - Patients will be included until a eGFR of 30ml/min./1.73 m2), study medication will be stopped if GFR droppes below 15 ml/min

    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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