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    Clinical Trial Results:
    Effect of SGLT2 inhibition on coronary microvascular function in type 2 diabetes

    Summary
    EudraCT number
    		 2017-000240-17
    Trial protocol
    		 DK  
    Global end of trial date
    18 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2020
    First version publication date
    18 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ESTIMATE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg University Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, København NV, Denmark, 2400
    Public contact
    Eva Prescott, Bispebjerg University Hospital, 27201195 27201195, hannah.elena.suhrs@regionh.dk
    Scientific contact
    Eva Prescott, Bispebjerg University Hospital, 27201195 27201195, hannah.elena.suhrs@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
    30 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to evaluate the effect of treatment with SGLT2 inhibitors on the coronary microvasculature in patients with type 2 diabetes mellitus
    Protection of trial subjects
    none
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 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
    Denmark: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We included 26 participants between 21-06-2017 and 15-06-2018. Patient were followed for diabetes at the outpatient clinic at Bispebjerg University Hospital, Copenhagen, Denmark.

    Pre-assignment
    Screening details
    		 We screened hospital records of 1196 patients. A letter of invitation was sent to 322 patients who passed the initial pre-screening and 47 passed the second pre-screening after contact was established by phone.

    Period 1
    Period 1 title
    Intervention (overall) (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
    		 Empagliflozine
    Arm description
    		 12 weeks treatment with empagliflozine
    Arm type
    		 Experimental

    Investigational medicinal product name
    empagliflozine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg empagliflozine daily for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 12 weeks treatment with placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    glucosemonohydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet daily for 12 weeks

    Number of subjects in period 1
    		Empagliflozine Placebo
    Started
    26
    26
    Completed
    19
    19
    Not completed
    7
    7
         Physician decision
    2
    2
         reason unrelated to study
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention (overall)
    Reporting group description
    		 As the study was designes as a cross-over study, the same subjects participated in period 1 and period 2, receiving either active treatment or placebo.

    Reporting group values
    		 Intervention (overall) Total
    Number of subjects
    		 26 26
    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
    Units: years
        arithmetic mean (full range (min-max))
    		 60.5 (42 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 17 17
    coronary flow velocity reserve
    Units: ratio
        arithmetic mean (standard deviation)
    		 2.60 ± 0.56 -

    End points

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    End points reporting groups
    Reporting group title
    Empagliflozine
    Reporting group description
    		 12 weeks treatment with empagliflozine

    Reporting group title
    Placebo
    Reporting group description
    		 12 weeks treatment with placebo

    Primary: change in coronary flow velocity reserve

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    End point title
    		 change in coronary flow velocity reserve
    End point description
    Coronary flow velocity reserve is the ratio of the coronary flow velocity at hyperemia to rest. Change in coronary flow velocity reserve was the primary endpoint.
    End point type
    Primary
    End point timeframe
    Coronary flow velocity reserve was measured before and after 12 weeks treatment with empagliflozine and before and after 12 weeks treatment with placebo.Change in coronary flow velocity reserve was the primary endpoint.
    End point values
    		 Empagliflozine Placebo
    Number of subjects analysed
    19
    19
    Units: ratio
        arithmetic mean (standard deviation)
    -0.16 ± 0.58
    0.18 ± 0.60
    Statistical analysis title
    		 two-sample t-test
    Statistical analysis description
    Data was analyzed as two-sample t-test comparing changes within and between the empagliflozin treatment group and the placebo group after ensuring there was no carry over, sequence or period effect. Carry over effects were measured using the pkcross command in Stata 13.1 for cross-over design studies. Paired two-sample t-test was used for within allocation comparisons whereas unpaired two-sample t-test was used for between treatment allocation comparisons.
    Comparison groups
    Empagliflozine v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported at a scheduled clinical visit 1-3 weeks after initiating treatment and thereafter at a scheduled phone call approximately 14 days later. When needed extra phonecalls were planned.
    Adverse event reporting additional description
    Adverse event were registered by regular clinical visits and phone calls. Participants had a direct number to study staff on working days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Empagliflozine
    Reporting group description
    		 12 weeks treatment with empagliflozine

    Reporting group title
    Placebo
    Reporting group description
    		 12 weeks treatment with placebo

    Serious adverse events
    		 Empagliflozine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (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
    		 Empagliflozine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 26 (30.77%)
    5 / 26 (19.23%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Paget's disease of nipple
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Dizziness
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    drop in renal function
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Skin infection
         subjects affected / exposed
    4 / 26 (15.38%)
    2 / 26 (7.69%)
         occurrences all number
    5
    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.
    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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