Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effect of Empagliflozin and Semaglutide on Cardio-Renal Target Organ Damage in patients with type 2 diabetes – A randomized Trial

    Summary
    EudraCT number
    		 2019-000781-38
    Trial protocol
    		 DK  
    Global end of trial date
    04 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Feb 2023
    First version publication date
    23 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    sempa1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital, Diabetes og Hormonsygdomme
    Sponsor organisation address
    Palle Juul Jensens Boulevard 165, Aarhus, Denmark, 8200
    Public contact
    Esben Laugesen, Aarhus University Hospital, 0045 23886954, auh.doh.sempa@rm.dk
    Scientific contact
    Esben Laugesen, Aarhus University Hospital, 0045 30283068, esben.laugesen@clin.au.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
    10 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study has two co-primary aims: Aim 1: To test the hypothesis that treatment with empagliflozin, semaglutide or the combination vs. placebo improves arterial function in T2DM patients. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin). The main outcome is change in arterial stiffness assessed as carotid-femoral PWV. Aim 2: To test the hypothesis that treatment with empagliflozin, semaglutide or the combination vs. placebo improves renal oxygenation in T2DM patients. Further, we aim to compare the different treatment modalities with each other (empagliflozin vs semaglutide, combination vs semaglutide, combination vs empagliflozin). The main outcome is change in renal oxygenation assesed by magnetic resonance imaging (MRI).
    Protection of trial subjects
    Participants were contacted by phone and/or email every fourth week to ensure well-being. If needed and by the discretion of the investigator, additional contact was facilitated. The addition of supplementary therapy including anti-hyperglycemic drugs and antihypertensive medication was furthermore handled by study investigators.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2019
    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: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    32
    From 65 to 84 years
    88
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were primarily recruited through "e-Boks". If they responded, we sent written information about the trial.

    Pre-assignment
    Screening details
    		 Participants were invited to a screening meeting, at which the potential for in- or exclusion was evaluated through interview, physical examination and medical records.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The emapgliflozin and the tablet placebo was double-blinded. The semaglutide was open-label. The combination was open-label with respect to semaglutide, whereas empagliflozin was double-blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Empagliflozin
    Arm description
    		 Participants receiving Empagliflozin
    Arm type
    		 Active comparator

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

    Arm title
    		 Placebo
    Arm description
    		 Participants receiving tablet placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Glucosemonohydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo; One tablet once-daily

    Arm title
    		 Semaglutide
    Arm description
    		 Participants receiving semaglutide
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ozempic
    Investigational medicinal product code
    Other name
    Semaglutide
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.25 -> 0.5 mg -> 1.0 mg. Uptitration according to regular schedule.

    Arm title
    		 Combination
    Arm description
    		 Participants receiving semaglutide and empagliflozin
    Arm type
    		 Active comparator

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

    Investigational medicinal product name
    Ozempic
    Investigational medicinal product code
    Other name
    Semaglutide
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.25 -> 0.5 mg -> 1.0 mg. Uptitration according to regular schedule.

    Number of subjects in period 1
    		Empagliflozin Placebo Semaglutide Combination
    Started
    30
    30
    30
    30
    Completed
    28
    27
    27
    26
    Not completed
    2
    3
    3
    4
         Did not want to take the treatment
    1
    -
    -
    -
         Adverse event, non-fatal
    1
    2
    1
    4
         Gave no reason
    -
    1
    -
    -
         Side effects
    -
    -
    2
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Empagliflozin
    Reporting group description
    		 Participants receiving Empagliflozin

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receiving tablet placebo

    Reporting group title
    Semaglutide
    Reporting group description
    		 Participants receiving semaglutide

    Reporting group title
    Combination
    Reporting group description
    		 Participants receiving semaglutide and empagliflozin

    Reporting group values
    		 Empagliflozin Placebo Semaglutide Combination Total
    Number of subjects
    		 30 30 30 30 120
    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)
    		 70.4 ± 6.6 66.7 ± 6.8 69.7 ± 6.6 69.5 ± 6.8 -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 4 5 23
        Male
    		 22 24 26 25 97
    History of Cardiovascular Disease
    Units: Subjects
        Yes
    		 22 15 19 24 80
        No
    		 8 15 11 6 40
    Metformin
    Units: Subjects
        Yes
    		 26 26 27 29 108
        No
    		 4 4 3 1 12
    Insulin therapy
    Units: Subjects
        Yes
    		 9 7 7 3 26
        No
    		 21 23 23 27 94
    Renin-Angiotension-Aldosteron-Inhibitor
    Units: Subjects
        Yes
    		 23 25 24 27 99
        No
    		 7 5 6 3 21
    Calciumantagonist
    Units: Subjects
        Yes
    		 12 16 14 13 55
        No
    		 18 14 16 17 65
    Beta blocker
    Units: Subjects
        Yes
    		 10 8 16 13 47
        No
    		 20 22 14 17 73
    Thiazide/Loop diuretics
    Units: Subjects
        Yes
    		 13 9 13 7 42
        No
    		 17 21 17 23 78
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.6 ± 5.1 27.7 ± 4.3 27.9 ± 5.3 26.4 ± 4.0 -
    Duration of diabetes
    Units: year
        median (inter-quartile range (Q1-Q3))
    		 11 (5 to 19) 9.5 (5 to 12) 10.5 (4 to 17) 9.5 (4.5 to 12.5) -
    HbA1c
    Units: mmol/mol
        median (inter-quartile range (Q1-Q3))
    		 57 (52 to 63) 59 (51 to 68) 59 (51 to 63) 57 (51 to 68) -
    Glomerular Filtration Rate
    Units: ml/min/1.73 m2
        arithmetic mean (standard deviation)
    		 84 ± 19 91 ± 22 87 ± 19 79 ± 23 -
    Urine albumin/creatinine ratio
    Units: mg/g
        median (inter-quartile range (Q1-Q3))
    		 13.5 (9 to 31) 13.5 (5 to 91) 16 (8 to 70) 21 (7 to 78) -
    Office systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 142 ± 14 144 ± 25 139 ± 17 138 ± 16 -
    Office diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 78 ± 9 82 ± 11 78 ± 8 76 ± 9 -
    24 h systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 132 ± 11 134 ± 15 126 ± 14 130 ± 12 -
    24 h diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 77 ± 8 82 ± 7 76 ± 8 77 ± 8 -
    Cf-PWV
    Units: m/s
        arithmetic mean (standard deviation)
    		 9.7 ± 1.8 10.1 ± 1.5 9.3 ± 2.0 9.5 ± 1.8 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Empagliflozin
    Reporting group description
    		 Participants receiving Empagliflozin

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receiving tablet placebo

    Reporting group title
    Semaglutide
    Reporting group description
    		 Participants receiving semaglutide

    Reporting group title
    Combination
    Reporting group description
    		 Participants receiving semaglutide and empagliflozin

    Primary: Kidney cortical oxygenation

    		 Close Top of page
    End point title
    		 Kidney cortical oxygenation
    End point description
    End point type
    Primary
    End point timeframe
    Week 32
    End point values
    		 Empagliflozin Placebo Semaglutide Combination
    Number of subjects analysed
    16
    16
    16
    16
    Units: Hz
        number (confidence interval 95%)
    23.3 (22.5 to 24.0)
    23.5 (22.7 to 24.2)
    23.5 (22.8 to 24.2)
    23.5 (22.8 to 24.3)
    Statistical analysis title
    		 Empagliflozin vs placebo
    Comparison groups
    Empagliflozin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.653
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.6
    Statistical analysis title
    		 Semaglutide vs placebo
    Comparison groups
    Semaglutide v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.869
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.8
    Statistical analysis title
    		 Combination vs placebo
    Comparison groups
    Placebo v Combination
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.811
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.8

    Primary: Kidney medullary oxygenation

    		 Close Top of page
    End point title
    		 Kidney medullary oxygenation
    End point description
    End point type
    Primary
    End point timeframe
    Week 32
    End point values
    		 Empagliflozin Placebo Semaglutide Combination
    Number of subjects analysed
    16
    16
    16
    16
    Units: Hz
        number (confidence interval 95%)
    25.4 (24.7 to 26.2)
    24.5 (23.9 to 25.1)
    24.4 (23.7 to 25.0)
    25.4 (24.7 to 26.2)
    Statistical analysis title
    		 Empagliflozin vs placebo
    Comparison groups
    Empagliflozin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.7
    Statistical analysis title
    		 Semaglutide vs placebo
    Comparison groups
    Placebo v Semaglutide
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.734
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.6
    Statistical analysis title
    		 Combination vs placebo
    Comparison groups
    Placebo v Combination
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.6

    Primary: Cf-PWV

    		 Close Top of page
    End point title
    		 Cf-PWV
    End point description
    End point type
    Primary
    End point timeframe
    32 weeks
    End point values
    		 Empagliflozin Placebo Semaglutide Combination
    Number of subjects analysed
    28
    26
    26
    26
    Units: m/s
        number (confidence interval 95%)
    9.6 (9.2 to 10.1)
    9.3 (8.9 to 9.8)
    9.9 (9.5 to 10.4)
    9.5 (9.0 to 9.9)
    Statistical analysis title
    		 Empagliflozin vs placebo
    Comparison groups
    Placebo v Empagliflozin
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.8
    Statistical analysis title
    		 Semaglutide vs placebo
    Comparison groups
    Placebo v Semaglutide
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.004
         upper limit
    		 1.1
    Statistical analysis title
    		 Combination vs placebo
    Comparison groups
    Placebo v Combination
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.7

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    01-08-2019 -> 04-04-2022
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Empagliflozin
    Reporting group description
    		 Participants receiving Empagliflozin

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receiving tablet placebo

    Reporting group title
    Semaglutide
    Reporting group description
    		 Participants receiving semaglutide

    Reporting group title
    Combination
    Reporting group description
    		 Participants receiving semaglutide and empagliflozin

    Serious adverse events
    		 Empagliflozin Placebo Semaglutide Combination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    4 / 30 (13.33%)
    7 / 30 (23.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer obs pro
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    TCI/Stroke obs pro
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ACS/AFLI obs. pro
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vascular occlusion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Blood in faeces/Ileus
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bladder/Lungs
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Empagliflozin Placebo Semaglutide Combination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    23 / 30 (76.67%)
    26 / 30 (86.67%)
    27 / 30 (90.00%)
    Nervous system disorders
    Headache/Dizziness
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    9
    9
    9
    9
    Eye disorders
    Eye disease
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    5
    5
    5
    5
    Gastrointestinal disorders
    Gastrointestinal symptoms
         subjects affected / exposed
    4 / 30 (13.33%)
    8 / 30 (26.67%)
    23 / 30 (76.67%)
    23 / 30 (76.67%)
         occurrences all number
    58
    58
    58
    58
    Respiratory, thoracic and mediastinal disorders
    Airways
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    8
    8
    8
    8
    Skin and subcutaneous tissue disorders
    Skin
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    9
    9
    9
    9
    Renal and urinary disorders
    Urinary diseases
         subjects affected / exposed
    14 / 30 (46.67%)
    5 / 30 (16.67%)
    3 / 30 (10.00%)
    10 / 30 (33.33%)
         occurrences all number
    32
    32
    32
    32
    Endocrine disorders
    Metabolism/Glucose
         subjects affected / exposed
    4 / 30 (13.33%)
    5 / 30 (16.67%)
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    14
    14
    14
    14
    Musculoskeletal and connective tissue disorders
    Musculoskeletal symptoms
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    5
    5
    5
    5
    Infections and infestations
    Infections
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    5 / 30 (16.67%)
    4 / 30 (13.33%)
         occurrences all number
    13
    13
    13
    13

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Sep 2019
    Inclusion criterion HbA1c was lowered from 55 mmol/mol to 48 mmol/mol. Inclusion criterion: 50 years or older with eGFR below 60 ml/min/1.73 m2 was added. Inclusion criterion: 60 years or older with persistent hypertension was added Exclusion criterion eGFR was lowered to be below 45 ml/min/1.73 m2
    05 Oct 2020
    Change of secondary endpoints regarding insulin sensitivity and glucose measurements Removal of the Oral Minimal Model

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Mar 2020
    Due to the COVID.19 Pandemic, the trial inclusion and planned outcome assessments halted, however participants already enrolled continued the take the allocated intervention.
    11 May 2020

    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.

    European Medicines Agency © 1995-Thu May 02 21:13:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA