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    Clinical Trial Results:
    A randomized, double-blind, multicenter study to assess the efficacy and safety of a 6 months oral treatment with the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease

    Summary
    EudraCT number
    		 2017-000656-26
    Trial protocol
    		 SE   FI   DK   ES   BG   IT  
    Global end of trial date
    10 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2020
    First version publication date
    27 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1142524/18933
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03412006
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, 51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    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 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the change in urinary albumin-to-creatinine ratio (UACR) from baseline values obtained at Visit 1 to 6 months after treatment with fulacimstat (BAY1142524), in comparison to placebo, on top of standard of care therapy
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 Background treatment for diabetic kidney disease comprised the treatment with an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme inhibitor (ACEI) at the maximum tolerated dose since at least 3 months prior to the screening visit whereby the maximum tolerated dose had to be at least as high as the minimal recommended target dose of an ACEI or ARB according to international or local guidelines.
    Evidence for comparator
    		 No
    Actual start date of recruitment
    02 Feb 2018
    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
    Spain: 19
    Country: Number of subjects enrolled
    Sweden: 13
    Country: Number of subjects enrolled
    Bulgaria: 32
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Finland: 26
    Country: Number of subjects enrolled
    Israel: 41
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    147
    EEA total number of subjects
    106
    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)
    36
    From 65 to 84 years
    111
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient first visit of the study was on 02-Feb-2018 and last patient last visit on 10-Oct-2019.

    Pre-assignment
    Screening details
    		 361 subjects were screened of whom 214 patients were screening failures.147 patients were randomized and treated. 139 patients completed the treatment phase, of whom 1 patient did not complete the follow-up. In total, 144 patients completed the follow-up.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fulacimstat
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fulacimstat
    Investigational medicinal product code
    BAY1142524
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg twice (BID) for 24 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching Fulacimstat 25 mg tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For 24 weeks

    Number of subjects in period 1
    		Fulacimstat Placebo
    Started
    99
    48
    Completed
    94
    45
    Not completed
    5
    3
         Adverse event, non-fatal
    3
    2
         Non-compliance to study drug
    1
    -
         Failure to meet continuation criteria
    -
    1
         Protocol deviation
    1
    -

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Fulacimstat Placebo Total
    Number of subjects
    		 99 48 147
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 16 36
        From 65-84 years
    		 79 32 111
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.1 ( 6.3 ) 66.5 ( 7.8 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 15 8 23
        Male
    		 84 40 124
    Albuminuria at Visit 1
    Units: Subjects
        Microalbuminuria
    		 78 32 110
        Macroalbuminuria
    		 21 16 37
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 31.38 ( 4.89 ) 31.18 ( 4.68 ) -
    Urinary albumin-to-creatinine ratio (UACR) at Visit 1
    Units: mg/g
        median (full range (min-max))
    		 140.80 (31.56 to 2429) 129.85 (29.59 to 2156) -
    Estimated glomerular filtration rate (eGFR) at Visit 1
    Units: mL/min/1.73 m2
        arithmetic mean (standard deviation)
    		 60.5 ( 17.1 ) 61.2 ( 16.5 ) -
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set included all enrolled patients who received at least 1 dose of study medication.

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPS included all enrolled patients who completed the treatment period according to protocol.

    Subject analysis sets values
    		 Safety Analysis Set (SAF) Per protocol set (PPS)
    Number of subjects
    147
    121
    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)
    36
        From 65-84 years
    111
        85 years and over
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    68.2 ( 6.9 )
    68.2 ( 7.0 )
    Gender Categorical
    Units: Subjects
        Female
    23
    19
        Male
    124
    102
    Albuminuria at Visit 1
    Units: Subjects
        Microalbuminuria
    110
    90
        Macroalbuminuria
    37
    31
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    31.31 ( 4.81 )
    31.14 ( 4.84 )
    Urinary albumin-to-creatinine ratio (UACR) at Visit 1
    Units: mg/g
        median (full range (min-max))
    131.69 (29.59 to 2429)
    131.69 (31.56 to 2429)
    Estimated glomerular filtration rate (eGFR) at Visit 1
    Units: mL/min/1.73 m2
        arithmetic mean (standard deviation)
    60.77 ( 16.90 )
    60.11 ( 16.13 )

    End points

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    End points reporting groups
    Reporting group title
    Fulacimstat
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set included all enrolled patients who received at least 1 dose of study medication.

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPS included all enrolled patients who completed the treatment period according to protocol.

    Primary: Change in urinary albumin to creatinine ratio (UACR) for total population

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    End point title
    		 Change in urinary albumin to creatinine ratio (UACR) for total population
    End point description
    The change in urinary albumin to creatinine ratio (UACR) between baseline and 6 months after treatment with fulacimstat, in comparison to placebo, on top of standard of care therapy, for patients with either microalbumanuria or macroalbumnuria (total population; PPS).
    End point type
    Primary
    End point timeframe
    Baseline and at 6 months
    End point values
    		 Fulacimstat Placebo
    Number of subjects analysed
    83
    38
    Units: None
    geometric mean (standard deviation)
        UACR (for PPS)
    1.030 ( 2.146 )
    1.274 ( 2.105 )
    Statistical analysis title
    		 Treatment effect (Total population; PPS)
    Statistical analysis description
    Fulacimstat/Placebo for PPS
    Comparison groups
    Fulacimstat v Placebo
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1477
    Method
    		 ANCOVA
    Parameter type
    		 LS mean ratio (fulacimstat/placebo)
    Point estimate
    0.804
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.627
         upper limit
    		 1.03

    Secondary: Number of subjects with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAEs)
    End point description
    Number of subjects with treatment-emergent adverse events (TEAEs)
    End point type
    Secondary
    End point timeframe
    From first intake of study drug up to 3 days after last administration of study drug
    End point values
    		 Fulacimstat Placebo
    Number of subjects analysed
    99
    48
    Units: Subjects
        Any TEAE
    64
    28
        TEAEs with intensity = Mild
    38
    15
        TEAEs with intensity = Moderate
    22
    13
        TEAEs with intensity = Severe
    4
    0
        Drug-related TEAEs
    12
    2
        Drug-related TEAEs with intensity = Mild
    8
    2
        Drug-related TEAEs with intensity = Moderate
    4
    0
        TEAEs related to protocol procedures
    0
    0
        TEAEs leading to drug discontinuation
    3
    1
        Any serious TEAE (TESAEs)
    5
    5
        Study drug-related TESAEs
    0
    0
        TESAEs related to protocol procedures
    0
    0
        TESAEs leading to drug discontinuation
    1
    1
        TEAEs with outcome death
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of drug up to 3 days after last administration of drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Fulacimstat
    Reporting group description
    		 All enrolled patients who received at least 1 dose of fulacimstat

    Reporting group title
    Placebo
    Reporting group description
    		 All enrolled patients who received at least 1 dose of placebo

    Serious adverse events
    		 Fulacimstat Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 99 (5.05%)
    5 / 48 (10.42%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hernia repair
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureteric obstruction
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fulacimstat Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 99 (64.65%)
    27 / 48 (56.25%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prolactin-producing pituitary tumour
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Hypotension
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Peripheral venous disease
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 48 (0.00%)
         occurrences all number
    4
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Pyrexia
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 48 (4.17%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Haemoptysis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Lung hypoinflation
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Product issues
    Device failure
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 48 (4.17%)
         occurrences all number
    2
    2
    Cardiac murmur
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 99 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    2
    International normalised ratio decreased
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    Lipase increased
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 48 (4.17%)
         occurrences all number
    1
    2
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Upper limb fracture
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Porphyria
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Vitello-intestinal duct remnant
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Coronary artery disease
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Extrasystoles
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Tachycardia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Diastolic dysfunction
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 48 (2.08%)
         occurrences all number
    1
    2
    Headache
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 48 (0.00%)
         occurrences all number
    4
    0
    Sciatica
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Orthostatic intolerance
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 99 (3.03%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Diabetic retinopathy
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 48 (4.17%)
         occurrences all number
    2
    2
    Abdominal pain lower
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    4 / 99 (4.04%)
    3 / 48 (6.25%)
         occurrences all number
    4
    3
    Diarrhoea
         subjects affected / exposed
    3 / 99 (3.03%)
    1 / 48 (2.08%)
         occurrences all number
    4
    1
    Dry mouth
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 48 (4.17%)
         occurrences all number
    1
    2
    Hiatus hernia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    2
    Petechiae
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Polyuria
         subjects affected / exposed
    2 / 99 (2.02%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    Renal failure
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Renal impairment
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Ureterolithiasis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 48 (4.17%)
         occurrences all number
    2
    2
    Back pain
         subjects affected / exposed
    5 / 99 (5.05%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Muscle spasms
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    Myalgia
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 48 (4.17%)
         occurrences all number
    1
    2
    Tendonitis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Rheumatic disorder
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Ear infection
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 99 (4.04%)
    5 / 48 (10.42%)
         occurrences all number
    7
    5
    Sialoadenitis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 48 (0.00%)
         occurrences all number
    4
    0
    Urinary tract infection
         subjects affected / exposed
    5 / 99 (5.05%)
    1 / 48 (2.08%)
         occurrences all number
    6
    1
    Soft tissue infection
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    3 / 99 (3.03%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Hyperkalaemia
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    4 / 99 (4.04%)
    3 / 48 (6.25%)
         occurrences all number
    5
    6
    Hypokalaemia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    Iron deficiency
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    Vitamin B complex deficiency
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 May 2018
    Amendment 01 (CSP v2.0) introduced changes regarding the inclusion of patients (ARB/ACEI medications, blood pressure and glycated hemoglobin [HbA1c] values), expected enrollment number, withdrawal of patients and handling of clinically relevant changes in safety parameters.

    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
    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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