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

    Summary
    EudraCT number
    		 2019-004447-80
    Trial protocol
    		 DK  
    Global end of trial date
    03 Jan 2023

    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-2-2019
    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
    Hospitalparken 15 , Herning, Denmark, 7400
    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
    03 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2023
    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 type 2 diabetes and chronic kidney disease
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 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: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    5
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 19
    Number of subjects completed
    		 19

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

    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 x 1 day

    Number of subjects in period 1
    		Placebo
    Started
    19
    Completed
    17
    Not completed
    2
         Consent withdrawn by subject
    1
         Non-compliance
    1
    Period 2
    Period 2 title
    Empaglilfozin
    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
    		 -
    Arm type
    		 Active comparator

    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 1 daily

    Number of subjects in period 2
    		Empagliflozin
    Started
    17
    Completed
    17

    Baseline characteristics

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

    Reporting group values
    		 Placebo Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.2 ( 5.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 18 18

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Empagliflozin
    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
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    16
    16
    Units: ml/min/ccm
        geometric mean (inter-quartile range (Q1-Q3))
    1.04 (0.89 to 1.15)
    0.98 (0.82 to 1.17)
    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: GFR

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    End point title
    		 GFR
    End point description
    End point type
    Secondary
    End point timeframe
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    17
    17
    Units: ml/min/1.73m2
        geometric mean (inter-quartile range (Q1-Q3))
    41.3 (38.4 to 49.0)
    37.7 (32.9 to 46.8)
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Empagliflozin v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: RVR

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    End point title
    		 RVR
    End point description
    End point type
    Secondary
    End point timeframe
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    17
    17
    Units: mmHg/ml/min
        geometric mean (inter-quartile range (Q1-Q3))
    0.37 (0.27 to 0.45)
    0.38 (0.30 to 0.44)
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    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
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    17
    17
    Units: mmHg
        arithmetic mean (standard deviation)
    140 ( 15 )
    132 ( 12 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0097
    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
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    17
    17
    Units: mmHg
        arithmetic mean (standard deviation)
    80 ( 9 )
    76 ( 7 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.043
    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
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    17
    17
    Units: dyn/s/m5
        arithmetic mean (standard deviation)
    1909 ( 280 )
    1827 ( 246 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Empagliflozin v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: heart rate

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    End point title
    		 heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    at the end of each period
    End point values
    		 Placebo Empagliflozin
    Number of subjects analysed
    17
    17
    Units: min-1
        median (standard deviation)
    64 ( 10 )
    63 ( 10 )
    Statistical analysis title
    		 paired t-test
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the begining 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
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    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
    10 / 19 (52.63%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Intertrigo
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Urogenital disorder
    Additional description: Increased urinary urge
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eye disorders
    blurred vision
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Contusion
    Additional description: contusion of knee
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Amputation
    Additional description: amputation of toe due to preexisting chronic ulcer
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Muscle discomfort
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    1 / 19 (5.26%)
         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
    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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