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    Clinical Trial Results:
    Low-Dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People with Type 1 Diabetes

    Summary
    EudraCT number
    		 2020-000551-12
    Trial protocol
    		 DK  
    Global end of trial date
    04 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2022
    First version publication date
    25 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    72418
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04449692
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Regional Committee on Health Research Ethics: H-20013256
    Sponsors
    Sponsor organisation name
    Steno Diabetes Center Copenhagen
    Sponsor organisation address
    Borgmester Ib Juuls Vej 83, Herlev, Denmark, 2730
    Public contact
    Christian Laugesen, Steno Diabetes Center Copenhagen, +45 51642387, christian.laugesen@regionh.dk
    Scientific contact
    Christian Laugesen, Steno Diabetes Center Copenhagen, +45 51642387, christian.laugesen@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
    01 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to compare the efficacy of low-dose (80 and 120 μg) dasiglucagon to oral carbohydrate (15 g) consumption for prevention of s.c. insulin-induced hypoglycemia in people with type 1 diabetes.
    Protection of trial subjects
    NA
    Background therapy
    		 All participants used their regular treatment modality; 10 participants used insulin pump therapy and 10 participants used MDI therapy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 2020
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from the outpatient diabetes clinic at Steno Diabetes Center Copenhagen from June 2020 to October 2020.

    Pre-assignment
    Screening details
    		 After providing oral and written informed consent, participants completed a screening visit for assessment of the eligibility criteria. Procedures included routine blood sampling, physical examination, review of medical history and medications as well as registration of baseline characteristics.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The study was a partially single-blind study. The participants were not blinded to the dose of the two dasiglucagon interventions; however, they were not blinded to the oral glucose intervention.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 15 g oral glucose (CHO)
    Arm description
    		 15 g oral glucose (CHO) from dextrose tablets (Dextro Energy GmbH & Co. KG, Germany)
    Arm type
    		 Standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 80 µg s.c. dasiglucagon (D80)
    Arm description
    		 80 µg dasiglucagon (D80) s.c. injection into a lifted skinfold of the abdominal wall.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dasiglucagon
    Investigational medicinal product code
    Other name
    CAS15 number: 1544300-84-6, EV Substance code: SUB193123
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    80 µg dasiglucagon (D80)was administered at t=0 as a s.c. injection into a lifted skinfold in the abdominal wall.

    Arm title
    		 120 µg dasiglucagon (D120)
    Arm description
    		 120 µg dasiglucagon (D120) s.c. injection into a lifted skinfold of the abdominal wall.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dasiglucagon
    Investigational medicinal product code
    Other name
    CAS15 number: 1544300-84-6, EV Substance code: SUB193123
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 µg dasiglucagon was administered at t=0 as a s.c. injection into a lifted skinfold in the abdominal wall.

    Number of subjects in period 1
    		15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg dasiglucagon (D120)
    Started
    20
    20
    20
    Completed
    20
    19
    20
    Not completed
    0
    1
    0
         Work-related reasons, not related to study
    -
    1
    -

    Baseline characteristics

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

    Reporting group values
    		 Study period Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    Units: years
        median (full range (min-max))
    		 47 (23 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 12 12
    Duration of type 1 diabetes
    Units: year
        median (full range (min-max))
    		 19 (3 to 58) -
    Body mass index
    Units: kilogram(s)/square metre
        median (full range (min-max))
    		 24.7 (21.6 to 36.4) -
    Total daily insulin dose
    Units: unit(s)
        median (full range (min-max))
    		 35 (20 to 65) -
    HbA1c
    Units: percent
        median (full range (min-max))
    		 6.8 (4.9 to 7.7) -
    Subject analysis sets

    Subject analysis set title
    15 g oral glucose (CHO)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    15 g oral glucose (CHO) intervention

    Subject analysis set title
    80 µg s.c. dasiglucagon (D80)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    80 µg s.c. dasiglucagon (D80) intervention

    Subject analysis set title
    120 µg s.c. dasiglucagon (D120)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    120 µg s.c. dasiglucagon (D120) intervention

    Subject analysis sets values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects
    20
    19
    20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    8
    8
    8
        Male
    12
    12
    12
    Duration of type 1 diabetes
    Units: year
        median (full range (min-max))
    Body mass index
    Units: kilogram(s)/square metre
        median (full range (min-max))
    Total daily insulin dose
    Units: unit(s)
        median (full range (min-max))
    HbA1c
    Units: percent
        median (full range (min-max))

    End points

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    End points reporting groups
    Reporting group title
    15 g oral glucose (CHO)
    Reporting group description
    		 15 g oral glucose (CHO) from dextrose tablets (Dextro Energy GmbH & Co. KG, Germany)

    Reporting group title
    80 µg s.c. dasiglucagon (D80)
    Reporting group description
    		 80 µg dasiglucagon (D80) s.c. injection into a lifted skinfold of the abdominal wall.

    Reporting group title
    120 µg dasiglucagon (D120)
    Reporting group description
    		 120 µg dasiglucagon (D120) s.c. injection into a lifted skinfold of the abdominal wall.

    Subject analysis set title
    15 g oral glucose (CHO)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    15 g oral glucose (CHO) intervention

    Subject analysis set title
    80 µg s.c. dasiglucagon (D80)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    80 µg s.c. dasiglucagon (D80) intervention

    Subject analysis set title
    120 µg s.c. dasiglucagon (D120)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    120 µg s.c. dasiglucagon (D120) intervention

    Primary: Time below target glucose range (<3.9 mmol/L)

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    End point title
    		 Time below target glucose range (<3.9 mmol/L) [1]
    End point description
    End point type
    Primary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In cases where oral rescue treatment was provided, the nadir plasma glucose concentration was carried forward to the end of the observation period (t=180) in data analysis. Missing plasma glucose values were extrapolated from the closest measurements using linear interpolation. The three-way comparison of the interventions were compared using a repeated-measures ANOVA analysis (p=0.273).
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: percent
        arithmetic mean (standard error)
    14 ± 6
    7 ± 3
    6 ± 3
    No statistical analyses for this end point

    Secondary: Hypoglycemia events (<3.9 mmol/L)

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    End point title
    		 Hypoglycemia events (<3.9 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: No. of subjects
    10
    5
    4
    No statistical analyses for this end point

    Secondary: Oral glucose rescue treatment events (<3.0 mmol/L)

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    End point title
    		 Oral glucose rescue treatment events (<3.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: No. of subjects
    4
    3
    2
    No statistical analyses for this end point

    Secondary: Time to oral glucose rescue treatment

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    End point title
    		 Time to oral glucose rescue treatment
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: minute
        arithmetic mean (standard error)
    120 ± 30
    160 ± 3
    110 ± 10
    No statistical analyses for this end point

    Secondary: Time to glucose increase of 1.1 mmol/L

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    End point title
    		 Time to glucose increase of 1.1 mmol/L
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: minute
        median (standard error)
    30 ± 3.5
    15 ± 1.6
    15 ± 1.6
    No statistical analyses for this end point

    Secondary: Time in target glucose range (3.9-10.0 mmol/L)

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    End point title
    		 Time in target glucose range (3.9-10.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: percent
        arithmetic mean (standard error)
    85 ± 6
    92 ± 3
    88 ± 5
    No statistical analyses for this end point

    Secondary: Time above target glucose range (>10.0 mmol/L)

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    End point title
    		 Time above target glucose range (>10.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: percent
        arithmetic mean (standard error)
    1 ± 1
    1 ± 1
    5 ± 4
    No statistical analyses for this end point

    Secondary: Hyperglycemia events (>10.0 mmol/L)

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    End point title
    		 Hyperglycemia events (>10.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: No. of subjects
    1
    1
    2
    No statistical analyses for this end point

    Secondary: Peak glucose

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    End point title
    		 Peak glucose
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: mmol/L
        arithmetic mean (standard error)
    7.5 ± 0.3
    7.7 ± 0.3
    8.4 ± 0.4
    No statistical analyses for this end point

    Secondary: Incremental peak glucose

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    End point title
    		 Incremental peak glucose
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: mmol/L
        arithmetic mean (standard error)
    3 ± 0.3
    3.1 ± 0.3
    3.8 ± 0.4
    No statistical analyses for this end point

    Secondary: Mean glucose

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    End point title
    		 Mean glucose
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: mmol/L
        arithmetic mean (standard error)
    5.6 ± 0.3
    6.3 ± 0.3
    6.7 ± 0.3
    No statistical analyses for this end point

    Secondary: Nadir glucose

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    End point title
    		 Nadir glucose
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: mmol/L
        median (standard error)
    3.9 ± 0.1
    4.5 ± 0.2
    4.5 ± 0.1
    No statistical analyses for this end point

    Secondary: Time to peak glucose

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    End point title
    		 Time to peak glucose
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: minute
        arithmetic mean (standard error)
    56 ± 3.7
    53 ± 3
    55 ± 3.3
    No statistical analyses for this end point

    Secondary: Glucose total Area Under the Curve

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    End point title
    		 Glucose total Area Under the Curve
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: mmol/L/min(t0-t180)
        arithmetic mean (standard error)
    1004 ± 49
    1123 ± 52
    1216 ± 63
    No statistical analyses for this end point

    Secondary: Baseline serum insulin

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    End point title
    		 Baseline serum insulin
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: pmol/L
        arithmetic mean (standard error)
    60 ± 11
    64 ± 13
    72 ± 12
    No statistical analyses for this end point

    Secondary: Insulin bolus at baseline

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    End point title
    		 Insulin bolus at baseline
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: units
        arithmetic mean (standard error)
    3 ± 0.4
    2.7 ± 0.3
    2.8 ± 0.4
    No statistical analyses for this end point

    Secondary: Serum insulin at time of intervention

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    End point title
    		 Serum insulin at time of intervention
    End point description
    End point type
    Secondary
    End point timeframe
    At the time of intervention (t=0)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: pmol/L
        arithmetic mean (standard error)
    130 ± 24
    117 ± 21
    112 ± 14
    No statistical analyses for this end point

    Secondary: Serum insulin total Area Under the Curve

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    End point title
    		 Serum insulin total Area Under the Curve
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 15 g oral glucose (CHO) 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    20
    19
    20
    Units: pmol/L/min(t0-t180)
        arithmetic mean (standard error)
    17159 ± 2598
    16929 ± 3092
    16177 ± 2164
    No statistical analyses for this end point

    Secondary: Peak plasma dasiglucagon

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    End point title
    		 Peak plasma dasiglucagon
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    19
    20
    Units: pmol/L
        arithmetic mean (standard error)
    283 ± 29
    409 ± 43
    No statistical analyses for this end point

    Secondary: Time to peak plasma dasiglucagon

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    End point title
    		 Time to peak plasma dasiglucagon
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    19
    20
    Units: minute
        arithmetic mean (standard error)
    24 ± 1.6
    23 ± 1.3
    No statistical analyses for this end point

    Secondary: Plasma dasiglucagon total Area Under the Curve

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    End point title
    		 Plasma dasiglucagon total Area Under the Curve
    End point description
    End point type
    Secondary
    End point timeframe
    From intervention (t=0) until the end of the observation period (t=180 min)
    End point values
    		 80 µg s.c. dasiglucagon (D80) 120 µg s.c. dasiglucagon (D120)
    Number of subjects analysed
    19
    20
    Units: pmol/L/min(t0-t180)
        arithmetic mean (standard error)
    17592 ± 872
    26918 ± 1591
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From intervention (t=0) to the end of the observation period (t=180 min)
    Adverse event reporting additional description
    Adverse effects (nausea, headache, stomachache, palpitations and injection site pain) were scored using a 0-100 visual analog scale (VAS) just prior to the intervention (t=0) and three hours later (t=180) to evaluate whether any adverse events had occurred within three hours after the intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    15 g oral glucose (CHO)
    Reporting group description
    		 Subjects who received 15 g oral glucose

    Reporting group title
    80 ug dasiglucagon (D80)
    Reporting group description
    		 Subjects who received 80 ug dasiglucagon

    Reporting group title
    120 ug dasiglucagon (D120)
    Reporting group description
    		 Subjects who received 120 ug dasiglucagon

    Serious adverse events
    		 15 g oral glucose (CHO) 80 ug dasiglucagon (D80) 120 ug dasiglucagon (D120)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 15 g oral glucose (CHO) 80 ug dasiglucagon (D80) 120 ug dasiglucagon (D120)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    8 / 19 (42.11%)
    8 / 20 (40.00%)
    General disorders and administration site conditions
    Nausea
    Additional description: If scoring of nausea (using a visual analog scale) was higher after exposure to the intervention (up to 3 hours after) compared to baseline (t = 0).
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 19 (26.32%)
    5 / 20 (25.00%)
         occurrences all number
    1
    5
    5
    Headache
    Additional description: If scoring of headache (using a visual analog scale) was higher after exposure to the intervention (up to 3 hours after) compared to baseline (t = 0).
         subjects affected / exposed
    4 / 20 (20.00%)
    5 / 19 (26.32%)
    4 / 20 (20.00%)
         occurrences all number
    4
    5
    4
    Stomachache
    Additional description: If scoring of stomachache (using a visual analog scale) was higher after exposure to the intervention (up to 3 hours after) compared to baseline (t = 0).
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 19 (10.53%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    Palpitations
    Additional description: If scoring of (subjective feeling of) palpitations (using a visual analog scale) was higher after exposure to the intervention (up to 3 hours after) compared to baseline (t = 0).
         subjects affected / exposed
    2 / 20 (10.00%)
    3 / 19 (15.79%)
    1 / 20 (5.00%)
         occurrences all number
    2
    3
    1
    Injection site pain
    Additional description: If injection site pain was noticed after exposure to the intervention (up to 3 hours after).
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0

    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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    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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