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    Clinical Trial Results:
    Randomized, placebo controlled, crossover clinical study to analyse the effect of dapagliflozin on microvascular and macrovascular circulation and total body sodium content

    Summary
    EudraCT number
    		 2013-004169-14
    Trial protocol
    		 DE  
    Global end of trial date
    20 Feb 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    BMS-MB102-210
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Ulmenweg 4, Erlangen, Germany, 91054
    Public contact
    Clinical Research Centre, Medizinische Klinik 4, 0049 091318536245, roland.schmieder@uk-erlangen.de
    Scientific contact
    Clinical Research Centre, Medizinische Klinik 4, 0049 091318536245, roland.schmieder@uk-erlangen.de
    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
    20 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of dapagliflozin on endothelial and microvascular function of the retinal circulation using Scanning-laser-Doppler-Flowmetry by assessing retinal capillary flow.
    Protection of trial subjects
    All visits were performed including physical examination and measurement of glucose Levels (fasting blood glucose), safety laboratory markers - including biochemistry, haematology and urinalysis - and vital signs (i.e. casual blood pressure and heart rate) as well as checking concomitant medication and assessment of adverse Events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2014
    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
    Germany: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    45
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from the University Outpatient Clinic, referring physicians, and advertisements in local newspapers. After a first contact by phone eligible patients were invited to an interview and selected using a standardized questionnaire.

    Pre-assignment
    Screening details
    		 Female and male patients aged between 18 and 70 years with type 2 diabetes. All eligible patients received respective advice and started to washout blood glucose lowering medication (if applicable) during the 4 weeks wash-out phase, and had an additional Visit after 2 weeks (Visit -2).

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Dapagliflozin
    Arm description
    		 The study followed randomized cross-over-design, i.e. subjects underwent both treatment arms in randomized order for 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily

    Arm title
    		 Placebo
    Arm description
    		 The study followed randomized cross-over-design, i.e. subjects underwent both treatment arms in randomized order for 6 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Number of subjects in period 1
    		Dapagliflozin Placebo
    Started
    62
    62
    Completed
    59
    59
    Not completed
    3
    3
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period 1 Total
    Number of subjects
    		 62 62
    Age categorical
    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)
    		 45 45
        From 65-84 years
    		 17 17
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 39 39

    End points

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    End points reporting groups
    Reporting group title
    Dapagliflozin
    Reporting group description
    		 The study followed randomized cross-over-design, i.e. subjects underwent both treatment arms in randomized order for 6 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 The study followed randomized cross-over-design, i.e. subjects underwent both treatment arms in randomized order for 6 weeks

    Primary: the effect of dapagliflozin on endothelial and microvascular function of the retinal circulation

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    End point title
    		 the effect of dapagliflozin on endothelial and microvascular function of the retinal circulation
    End point description
    using scanning-laser-doppler-Flowmetry by assessing retinal capillary flow (RCF)
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: AU
        arithmetic mean (standard deviation)
    308 ± 78
    318 ± 87
    Statistical analysis title
    		 effect of Dapagliflozin on retinal circulation
    Comparison groups
    Dapagliflozin v Placebo
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 2.5

    Secondary: effect of Dapagliflozin on central SBP

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    End point title
    		 effect of Dapagliflozin on central SBP
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: mmHg
        arithmetic mean (standard deviation)
    118 ± 12
    121 ± 13
    No statistical analyses for this end point

    Secondary: effect of Dapagliflozin on central pulse pressure

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    End point title
    		 effect of Dapagliflozin on central pulse pressure
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: mmHg
        arithmetic mean (standard deviation)
    40.9 ± 11
    43.9 ± 12
    No statistical analyses for this end point

    Secondary: effect of Dapagliflozin on central augmentation pressure

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    End point title
    		 effect of Dapagliflozin on central augmentation pressure
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: mmHg
        arithmetic mean (standard deviation)
    12.9 ± 6.0
    13.5 ± 6.5
    No statistical analyses for this end point

    Secondary: effect of dapagliflozin of RCF after flicker light exposure

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    End point title
    		 effect of dapagliflozin of RCF after flicker light exposure
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: AU
        arithmetic mean (standard deviation)
    344 ± 115
    352 ± 101
    No statistical analyses for this end point

    Secondary: effect of dapagliflozin on sodium conc Musc. triceps surae

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    End point title
    		 effect of dapagliflozin on sodium conc Musc. triceps surae
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: AU
        arithmetic mean (standard deviation)
    20.4 ± 3.7
    20.3 ± 3.6
    No statistical analyses for this end point

    Secondary: effect of Dapagliflozin on office SBP

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    End point title
    		 effect of Dapagliflozin on office SBP
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: mmHg
        arithmetic mean (standard deviation)
    126 ± 12
    129 ± 13
    No statistical analyses for this end point

    Secondary: effect of Dapagliflozin on fasting plasma glucose

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    End point title
    		 effect of Dapagliflozin on fasting plasma glucose
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: mg/dl
        arithmetic mean (standard deviation)
    114 ± 19
    134 ± 32
    No statistical analyses for this end point

    Secondary: effect of Dapagliflozin on postprandial plasma glucose

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    End point title
    		 effect of Dapagliflozin on postprandial plasma glucose
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: mg/dl
        arithmetic mean (standard deviation)
    135 ± 32
    154 ± 46
    No statistical analyses for this end point

    Secondary: effect of dapagliflozin on sodium conc skin

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    End point title
    		 effect of dapagliflozin on sodium conc skin
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Dapagliflozin Placebo
    Number of subjects analysed
    59
    59
    Units: AU
        arithmetic mean (standard deviation)
    22.7 ± 6.4
    23.3 ± 7.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In the course of the intire study , each adverse event had to be reported on an Adverse Event Case Report Form as soon as known, in general at the subsequent study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    all patients treated with IMP
    Reporting group description
    		 -

    Serious adverse events
    		 all patients treated with IMP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 all patients treated with IMP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 62 (100.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    8 / 62 (12.90%)
         occurrences all number
    8
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    6
    Flatulence
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Toothache
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Cough
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Cystitis
         subjects affected / exposed
    7 / 62 (11.29%)
         occurrences all number
    7
    Influenza
         subjects affected / exposed
    3 / 62 (4.84%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    16 / 62 (25.81%)
         occurrences all number
    16

    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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