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    Clinical Trial Results:
    The Effect of Empagliflozin on Cardiac and Kidney Metabolism in Persons with Type 2 Diabetes

    Summary
    EudraCT number
    		 2017-001779-22
    Trial protocol
    		 DK  
    Global end of trial date
    19 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Mar 2021
    First version publication date
    05 Mar 2021
    Other versions
    Summary report(s)
    		 Summary and abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    04.2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AUH
    Sponsor organisation address
    Palle Juul-Jensens blv. , Aarhus N, Denmark, 8200
    Public contact
    Department of Endorcrinology, Aarhus University Hospital, katrine.mj@rm.dk
    Scientific contact
    Department of Endorcrinology, Aarhus University Hospital, katrine.mj@rm.dk
    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
    15 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Empagliflozin is a sodium–glucose cotransporter 2 (SGLT-2) inhibitor, and is used in treatment of diabetes type 2. It is previously shown that SGLT-2 inhibitors have a remarkable protective effect on the heart by reducing death caused by cardiac diseases with 38%. The reasons for these effects are still unknown, but it is known that SGLT-2 treatment increase ketogenesis. We have in a previous study found that ketone body infusion shifts cardiac metabolism towards ketone body oxidation, which possibly increases cardiac efficiency. It is also shown that SGLT-2 inhibitors have reno protective effects. The aim of this study is to examine the effects of SGLT-2 treatment by: - Examination of substrate metabolism in heart and kidney measured by PET. - Examination of perfusion and total energy consumption in the heart and kidney measured by PET. - Indirect calorimetry, bloodsamples, fat- and muscle biopsies, DXA-scan, measurement of arterial stiffness and oral glucose tolerance test.
    Protection of trial subjects
    Interviews about side effects to treatment GCP guidelines has been followed
    Background therapy
    		 Metformin
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 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
    Denmark: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    6
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited through advertisements in local press in the period between September 2017 - August 2019

    Pre-assignment
    Screening details
    		 • Age: 50-70 years • Type 2 diabetes for > 1 år • HbA1c: 48-75 mmol/mol • Metformin treatment as only anti diabetic medicin One-week walkout between study periods 23 volunteers were screened for inclusion. 13 participants were included. 1 withdraw consent due to claustrophobia during scans.

    Period 1
    Period 1 title
    Placebo and intervention in crossover (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Encapsulation of medicine. Randomization and encapsulation of medicine were handled by the hospital pharmacy. Randomization code was given after finalising data analysis

    Arms
    Arm title
    		 Placebo and intervention
    Arm description
    		 13 patients were randomized to receive placebo and Jardiance 25 mg in a crossover design. Both placebo and Jardiance were encapsulated. Comment: I found it necessary to choose the one arm design in this report. If I selected two arms, the number of participants were doubled.
    Arm type
    		 Placebo and intervention

    Investigational medicinal product name
    Jardiance
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg once daily encapsulated

    Number of subjects in period 1
    		Placebo and intervention
    Started
    13
    Completed
    12
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo and intervention in crossover
    Reporting group description
    		 -

    Reporting group values
    		 Placebo and intervention in crossover Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 7 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62 ( 6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 10 10
    Ischemic heart disease
    Units: Subjects
        Yes
    		 1 1
        No
    		 12 12
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 56.7 ( 5.5 ) -
    Diabetes duration
    Units: years
        arithmetic mean (standard deviation)
    		 4.6 ( 3.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo and intervention
    Reporting group description
    		 13 patients were randomized to receive placebo and Jardiance 25 mg in a crossover design. Both placebo and Jardiance were encapsulated. Comment: I found it necessary to choose the one arm design in this report. If I selected two arms, the number of participants were doubled.

    Primary: Cardiac uptake of free fatty acids

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    End point title
    		 Cardiac uptake of free fatty acids [1]
    End point description
    End point type
    Primary
    End point timeframe
    After four weeks of treatment
    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: Statistical analysis are described in the attached article (more information)
    End point values
    		 Placebo and intervention
    Number of subjects analysed
    12
    Units: umol/100g/min
    arithmetic mean (standard deviation)
        Jardiance
    7.7 ( 3.7 )
        Placebo
    8.2 ( 3.6 )
    Attachments
    		 Untitled (Filename: fig2_2_columns.pdf)
    No statistical analyses for this end point

    Primary: Cardiac glucose uptake

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    End point title
    		 Cardiac glucose uptake [2]
    End point description
    End point type
    Primary
    End point timeframe
    After four weeks of treatment
    Notes
    [2] - 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: Statistical analysis are described in the attached article (more information)
    End point values
    		 Placebo and intervention
    Number of subjects analysed
    11
    Units: umol/100g/min
    arithmetic mean (standard deviation)
        Jardiance
    0.6 ( 0.6 )
        Placebo
    1.4 ( 0.6 )
    Attachments
    		 Untitled (Filename: fig2_2_columns.pdf)
    No statistical analyses for this end point

    Primary: Cardiac oxygen consumption

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    End point title
    		 Cardiac oxygen consumption [3]
    End point description
    End point type
    Primary
    End point timeframe
    After four weeks of treatment
    Notes
    [3] - 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: Statistical analysis are described in the attached article (more information)
    End point values
    		 Placebo and intervention
    Number of subjects analysed
    10
    Units: ml/100g/min
    arithmetic mean (standard deviation)
        Jardiance
    8.8 ( 1.0 )
        Placebo
    9.7 ( 1.4 )
    Attachments
    		 Untitled (Filename: fig3_2_columns.pdf)
    No statistical analyses for this end point

    Primary: Myocardial perfusion in rest

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    End point title
    		 Myocardial perfusion in rest [4]
    End point description
    End point type
    Primary
    End point timeframe
    After four weeks of treatment
    Notes
    [4] - 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: Statistical analysis are described in the attached article (more information)
    End point values
    		 Placebo and intervention
    Number of subjects analysed
    10
    Units: ml/g/min
    arithmetic mean (standard deviation)
        Jardiance
    0.74 ( 0.10 )
        Placebo
    0.85 ( 0.10 )
    Attachments
    		 Untitled (Filename: fig3_2_columns.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    09.10.2017 - 19.12.2019
    Adverse event reporting additional description
    Weekly meetings with the participants with questions regarding adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    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: No adverse events have been reported

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33334875
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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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