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    Clinical Trial Results:
    A randomized, double-blinded, placebo-controlled trial that evaluates the effect of empagliflozin on oxidative stress in patients with type 2 diabetes

    Summary
    EudraCT number
    		 2016-000370-38
    Trial protocol
    		 DK  
    Global end of trial date
    22 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2021
    First version publication date
    04 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2016-100
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02890745
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital - Rigshospitalet, Q7642
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark,
    Public contact
    Henrik Enghusen Poulsen, Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Denmark, +45 35457695, henrik.enghusen.poulsen.01@regionh.dk
    Scientific contact
    Henrik Enghusen Poulsen, Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Denmark, +45 35457695, henrik.enghusen.poulsen.01@regionh.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
    01 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Urinary excretion rates of 8-oxo-7,8-dihydroguanosine (8-oxoGuo) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG) before and after treatment with empagliflozin compared to placebo treatment in addition to standard care in patients with type 2 diabetes
    Protection of trial subjects
    All data was stored in accordance with the Danish Law of data protection
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2016
    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
    Denmark: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    18
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment were done in relation to patients outpatient consultation at Gentofte Hospital and Bispebjerg Hospital as well as throug advertisements at public availiable material.

    Pre-assignment
    Screening details
    		 A screening visit is performed prior to enrollment in the study to ensure elibility of study criteria with an physical examination and disease and life style history

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Active arm. Empagliflozin 25 mg, once daily for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    empagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg, tablet, oral use

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    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
    Placebo, tablet, oral use

    Number of subjects in period 1 [1]
    		Intervention Placebo
    Started
    16
    15
    Completed
    16
    15
    Notes
    [1] - 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: A total number of 35 participants were enrolled in the study. However, 4 participants chose to withdrew before getting trial medicine, and were thus not included in the baseline information.

    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
    		 31 31
    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
    Mean: 63 SD: 7
    Units: years
        arithmetic mean (standard deviation)
    		 63 ± 7 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 31 31
    Body mass index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 30.9 ± 4.6 -
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 56 ± 7 -

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Active arm. Empagliflozin 25 mg, once daily for 14 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Changes in urinary excretion of 8-oxo-7,8-dihydroguanosine

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    End point title
    		 Changes in urinary excretion of 8-oxo-7,8-dihydroguanosine
    End point description
    End point type
    Primary
    End point timeframe
    Changes from baseline to end of study
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    16
    15
    Units: nmol/24h
        arithmetic mean (standard deviation)
    -0.5 ± 7.8
    -1.8 ± 8.5
    Statistical analysis title
    		 Between group effects 8-oxo-7,8-dihydroguanosine
    Comparison groups
    Placebo v Intervention
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.66
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 4.8

    Primary: Changes in urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine

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    End point title
    		 Changes in urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine
    End point description
    End point type
    Primary
    End point timeframe
    Changes from baseline to end of study
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    16
    15
    Units: nmol/24h
        arithmetic mean (standard deviation)
    -1.1 ± 5.3
    -1.5 ± 6.7
    Statistical analysis title
    		 Between group effects 8-oxo-7,8-dihydro-2'-deoxygu
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.89
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 4.8

    Secondary: Changes in plasma concentration of malondialdehyde

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    End point title
    		 Changes in plasma concentration of malondialdehyde
    End point description
    End point type
    Secondary
    End point timeframe
    Changes from baseline to end of study
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    16
    15
    Units: nmol/mL
        arithmetic mean (standard deviation)
    -0.13 ± 0.67
    0.08 ± 0.54
    Statistical analysis title
    		 Between group effect malondialdehyde
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.33
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.66
         upper limit
    		 0.23

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the study period (14 days) and one week afterwards
    Adverse event reporting additional description
    Daily text messages and at the end of study. If any occured the week following the study, participants contacted the investiagator
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Intervention group
    Reporting group description
    		 Empagliflozin 25 mg, once daily for 14 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for 14 days

    Serious adverse events
    		 Intervention group Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (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: 1%
    Non-serious adverse events
    		 Intervention group Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 16 (62.50%)
    6 / 15 (40.00%)
    Gastrointestinal disorders
    Increased thirst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nausea or changed stool consistence
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Genital fungal infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    9 / 16 (56.25%)
    1 / 15 (6.67%)
         occurrences all number
    9
    1
    Psychiatric disorders
    Tired
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Sprained finger
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2

    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.
    The project did not include 34 participants that succesfully completed the study. 35 partipants were enrolled, however, 4 participants withdrew before starting trial medicine. Thus, 31 participants succesfully completed the study.
    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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