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    Clinical Trial Results:
    A 24 week monocentric prospective randomized, placebo-controlled trial to evaluate Efficacy of combination of Exenatide and Dapagliflozin compared to Dapagliflozin and Placebo and its effects on hepatic, myocardial and pancreatic fat distribution in patients with uncontrolled type 2 diabetes mellitus.

    Summary
    EudraCT number
    		 2016-000574-38
    Trial protocol
    		 AT  
    Global end of trial date
    27 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2021
    First version publication date
    03 Mar 2021
    Other versions
    Summary report(s)
    		 Diabetes_Obesity_ and_Metabolism_2021

    Trial information

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    Trial identification
    Sponsor protocol code
    ESR-15-10882
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03007329
    WHO universal trial number (UTN)
    		 U1111-1179-3250
    Sponsors
    Sponsor organisation name
    Medical University Vienna
    Sponsor organisation address
    Spitalgasse 23, Wien, Austria, 1090
    Public contact
    Medical University Vienna, Medical University Vienna, +43 140400 21260, juergen.harreiter@meduniwien.ac.at
    Scientific contact
    Medical University Vienna, Medical University Vienna, +43 140400 21260, juergen.harreiter@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
    01 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to investigate the effects on hepatic lipid content reduction of combination therapy with dapagliflozin (10mg daily) and exenatide (2mg weekly) compared to dapagliflozin (10mg daily) and placebo given for 24 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control.
    Protection of trial subjects
    not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 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
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment was conducted between June 2017 to May 2019. In total 7 study visits were conducted during the study, which was a screening visit (week -4 to 0) followed by the randomization visit at baseline (week 0), study visits at 4,8,16,24 weeks and a follow-up visit at week 28.

    Pre-assignment
    Screening details
    		 Screening woindow was 4 weeks, in these 4 weeks all necessary examinations were performed. In total 563 were screened/prescreened of whom 533 were excluded. • Not meeting inclusion criteria (n=481) • Declined to participate (n=52)

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo
    Arm description
    		 placebo + dapagliflozin 10mg once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg once daily

    Arm title
    		 combined treatment
    Arm description
    		 exenatide 2mg + dapagliflozin 10mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg once daily

    Investigational medicinal product name
    exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2mg once weekly

    Number of subjects in period 1
    		placebo combined treatment
    Started
    14
    16
    Completed
    13
    16
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo + dapagliflozin 10mg once daily

    Reporting group title
    combined treatment
    Reporting group description
    		 exenatide 2mg + dapagliflozin 10mg

    Reporting group values
    		 placebo combined treatment Total
    Number of subjects
    		 14 16 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 7 11 18
        From 65-84 years
    		 7 5 12
        85 years and over
    		 0 0 0
        18
    		 0 0 0
        12
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.9 ( 7.4 ) 59.4 ( 8.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 10
        Male
    		 10 10 20
    liver fat content
    Units: 12.85 %
        arithmetic mean (standard deviation)
    		 13.17 ( 8.91 ) 12.85 ( 9.26 ) -

    End points

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    End points reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo + dapagliflozin 10mg once daily

    Reporting group title
    combined treatment
    Reporting group description
    		 exenatide 2mg + dapagliflozin 10mg

    Primary: liver fat content

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    End point title
    		 liver fat content
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 placebo combined treatment
    Number of subjects analysed
    14
    16
    Units: percentage
        arithmetic mean (standard deviation)
    9.30 ( 8.43 )
    8.43 ( 8.00 )
    Statistical analysis title
    		 statistical analysis
    Comparison groups
    placebo v combined treatment
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    screening - to follow up visit after 28 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    placebo
    Reporting group description
    		 placebo + dapagliflozin 10mg once daily

    Reporting group title
    combined treatment
    Reporting group description
    		 exenatide 2mg + dapagliflozin 10mg

    Serious adverse events
    		 placebo combined treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Otitis media acute
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 placebo combined treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 14 (85.71%)
    12 / 16 (75.00%)
    Gastrointestinal disorders
    Gastroinestinal Side Effects
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 16 (25.00%)
         occurrences all number
    1
    4
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    8 / 14 (57.14%)
    2 / 16 (12.50%)
         occurrences all number
    8
    2
    Infections and infestations
    Mycosis
         subjects affected / exposed
    2 / 14 (14.29%)
    5 / 16 (31.25%)
         occurrences all number
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2018
    Inclusion criteria were adapted: inclusion criteria was changed from HbA1c 7.0-11.0% to 6.5-11.0%.

    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/33464703
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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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