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    Clinical Trial Results:
    The effects of SGLT2-inhibition in patients with type 2 diabetes and preserved kidney function on renal hemodynamics, kidney function and vasoactive hormones

    Summary
    EudraCT number
    		 2019-004303-12
    Trial protocol
    		 DK  
    Global end of trial date
    08 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2025
    First version publication date
    22 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SFN-1-2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro
    Sponsor organisation address
    Lægårdvej 12, Holstebro, Denmark,
    Public contact
    Steffen Flindt Nielsen, University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro, 0045 78436588, steffen.nielsen@midt.rm.dk
    Scientific contact
    Steffen Flindt Nielsen, University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro, 0045 78436588, steffen.nielsen@midt.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
    08 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine the effects of SGLT2-inhibition versus placebo on renal hemodynamics in patients with typ2 diabetes and preserved kidney function. The trial was a double blind, randomized controlled cross over trial where each participant was randomized to 4 weeks of treatment with empagliflozin 10 mg per day and matching placebo in random order.
    Protection of trial subjects
    All participants signed informed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 May 2021
    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: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion and exclusion criterias have been specified at the beginning of the trial. 22 patients were screened, 4 were screen failures. 2 patients did not complete the study. 16 completed

    Period 1
    Period 1 title
    Treament period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Empagliflozin
    Arm description
    		 Crossed over design
    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
    10 mg x day

    Number of subjects in period 1
    		Empagliflozin
    Started
    18
    Completed
    16
    Not completed
    2
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
    Period 2
    Period 2 title
    Placebo period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Placebo
    Arm description
    		 -
    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
    1 tablet each day, identical to Empagliflozin except active treatment

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: This is a crossed over trial
    Number of subjects in period 2 [2]
    		Placebo
    Started
    16
    Completed
    16
    Notes
    [2] - 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: This is a crossover trial

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo period
    Reporting group description
    		 -

    Reporting group values
    		 Placebo period Total
    Number of subjects
    		 16 16
    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 (standard deviation)
    		 68.0 ( 8.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Empagliflozin
    Reporting group description
    		 Crossed over design
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Renal Blood Flow

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    End point title
    		 Renal Blood Flow
    End point description
    End point type
    Primary
    End point timeframe
    meassured at the end of each treatment period
    End point values
    		 Empagliflozin Placebo
    Number of subjects analysed
    15
    15
    Units: ml/min/ccm
        geometric mean (inter-quartile range (Q1-Q3))
    1.52 (1.27 to 1.85)
    1.57 (1.33 to 1.90)
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: GFR

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    End point title
    		 GFR
    End point description
    End point type
    Secondary
    End point timeframe
    at the end of each treatment period
    End point values
    		 Empagliflozin Placebo
    Number of subjects analysed
    16
    16
    Units: ml/min/1.73m2
        geometric mean (inter-quartile range (Q1-Q3))
    75.6 (66.7 to 94.3)
    97.6 (78.9 to 102.7)
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: systolic blood pressure

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    End point title
    		 systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    meassured at the end of each period
    End point values
    		 Empagliflozin Placebo
    Number of subjects analysed
    15
    15
    Units: mmHg
        arithmetic mean (standard deviation)
    131 ( 12 )
    135 ( 9 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: diastolic blood pressure

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    End point title
    		 diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    meassured at the end of each period
    End point values
    		 Empagliflozin Placebo
    Number of subjects analysed
    15
    15
    Units: mmHg
        arithmetic mean (standard deviation)
    77 ( 10 )
    79 ( 8 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0029
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: TVR

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    End point title
    		 TVR
    End point description
    End point type
    Secondary
    End point timeframe
    meassured at the end of each period
    End point values
    		 Empagliflozin Placebo
    Number of subjects analysed
    15
    15
    Units: dyn/s*m5
        arithmetic mean (standard deviation)
    1781 ( 130 )
    1829 ( 131 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the beginning of the trial to LPLV + 1 week
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    total trial
    Reporting group description
    		 -

    Serious adverse events
    		 total trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 total trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 18 (50.00%)
    Vascular disorders
    Aneurysm
    Additional description: Abdominal aortic aneurism detected during a CT scan
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    General disorders and administration site conditions
    Dizziness
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Immune system disorders
    Myasthenia gravis
    Additional description: Worsening of known myastenia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Muscle contusion
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Haematoma
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Balanitis candida
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1

    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/39810756
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