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    Clinical Trial Results:
    Fast-Acting Insulin Aspart and Insulin Pump Settings: “THE FAST PUMP SETTING STUDY”

    Summary
    EudraCT number
    		 2020-001158-23
    Trial protocol
    		 DK  
    Global end of trial date
    06 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2024
    First version publication date
    22 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    U1111-1243-4058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04620967
    WHO universal trial number (UTN)
    		 U1111-1243-4058
    Sponsors
    Sponsor organisation name
    Steno Diabetes Center Copenhagen
    Sponsor organisation address
    Borgmester Ib Juuls Vej 83, Herlev, Denmark, 2730
    Public contact
    Kirsten Nørgaard, Steno Diabetes Center Copenhagen, +45 27131011, kirsten.noergaard@regionh.dk
    Scientific contact
    Kirsten Nørgaard, Steno Diabetes Center Copenhagen, +45 27131011, kirsten.noergaard@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
    06 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the CGM-derived time in range (3.9-10.0 mmol/l) during the last two weeks of the 16-week interventions with Fiasp versus NovoRapid
    Protection of trial subjects
    N/A
    Background therapy
    		 All participants used their regular treatment modality (insulin pump therapy including contiunous glucose monitorering).
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Nov 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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    33
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from Steno Diabetes Center Copenhagen, Denmark, from February 2021 to June 2023

    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 edications as well as registration of baseline characteristics.

    Period 1
    Period 1 title
    Study period (overall) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The randomization codes were produced by Novo Nordisk who also provided the study medication in sealed and coded vials with a dispensing unit number. Unblinded staff, who were not involved in any other study activities, ensured the correct treatment allocation and dispensing of the study medication.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Faster aspart --> Insulin aspart
    Arm description
    		 First went through 16-weeks of faster aspart (Fiasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark) then 16-weeks of insulin aspart (Iasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faster-acting Insulin aspart
    Investigational medicinal product code
    A10AB05
    Other name
    Fiasp
    Pharmaceutical forms
    Solution for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Vial, 10 ml/vial, 100 U/ml, solution for subcutaneous injection.

    Investigational medicinal product name
    Insulin aspart
    Investigational medicinal product code
    A10AB05
    Other name
    Novorapid
    Pharmaceutical forms
    Solution for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Vial, 10 ml/vial, 100 U/ml, solution for subcutaneous injection.

    Arm title
    		 Insulin Aspart --> Faster aspart
    Arm description
    		 First 16-weeks of insulin aspart (NovoRapid® 100 U/mL; Novo Nordisk, Bagsværd, Denmark then 16-weeks of insulin aspart (Iasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin aspart
    Investigational medicinal product code
    A10AB05
    Other name
    Novorapid
    Pharmaceutical forms
    Solution for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Vial, 10 ml/vial, 100 U/ml, solution for subcutaneous injection.

    Investigational medicinal product name
    Faster-acting Insulin aspart
    Investigational medicinal product code
    A10AB05
    Other name
    Fiasp
    Pharmaceutical forms
    Solution for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Vial, 10 ml/vial, 100 U/ml, solution for subcutaneous injection.

    Number of subjects in period 1
    		Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Started
    20
    20
    Completed
    20
    19
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period (overall)
    Reporting group description
    		 -

    Reporting group values
    		 Study period (overall) Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 33 33
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 54 (44 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 20 20
    Previous faster insulin aspart users
    Units: Subjects
        Number of fiasp users
    		 6 6
        Number of iasp users
    		 34 34
    Insulin pump device
    Units: Subjects
        Medtronic MiniMed 640G
    		 33 33
        Omnipod Dash
    		 7 7
    CGM device type
    Units: Subjects
        Medtronic Guardian Sensor 3
    		 32 32
        Medtronic Guardian Connect
    		 0 0
        Dexcom G5
    		 1 1
        Dexcom G6
    		 7 7
    BMI
    Body mass index
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 25.7 (24.5 to 30.3) -
    HbA1c
    Hemoglobin A1c
    Units: mmol/mol
        median (inter-quartile range (Q1-Q3))
    		 59 (55 to 65) -
    Diabetes duration
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 27 (20 to 34) -
    Insulin pump use
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 11 (7 to 13) -
    CGM use
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 6 (3 to 9) -
    Total daily insulin dosis
    Units: IU
        median (inter-quartile range (Q1-Q3))
    		 37 (29 to 52) -

    End points

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    End points reporting groups
    Reporting group title
    Faster aspart --> Insulin aspart
    Reporting group description
    		 First went through 16-weeks of faster aspart (Fiasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark) then 16-weeks of insulin aspart (Iasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark)

    Reporting group title
    Insulin Aspart --> Faster aspart
    Reporting group description
    		 First 16-weeks of insulin aspart (NovoRapid® 100 U/mL; Novo Nordisk, Bagsværd, Denmark then 16-weeks of insulin aspart (Iasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark)

    Primary: Time in range (3.9-10.0 mmol/l)

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    End point title
    		 Time in range (3.9-10.0 mmol/l)
    End point description
    Assessed by CGM
    End point type
    Primary
    End point timeframe
    During the last two weeks of the 16-week interventions with Fiasp vs. Iasp
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    65.8 ( 11.5 )
    63.9 ( 11.9 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.59
         upper limit
    		 1.35
    Variability estimate
    Standard deviation
    Dispersion value
    1.74

    Secondary: Time below range (< 3.9 mmol/l)

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    End point title
    		 Time below range (< 3.9 mmol/l)
    End point description
    CGM assessed
    End point type
    Secondary
    End point timeframe
    The last two weeks of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    2.3 ( 1.5 )
    2.9 ( 2.1 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.82
         upper limit
    		 3
    Variability estimate
    Standard deviation
    Dispersion value
    1.6

    Secondary: Time above range (>10.0 mmol/l)

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    End point title
    		 Time above range (>10.0 mmol/l)
    End point description
    CGM assessed
    End point type
    Secondary
    End point timeframe
    The last two weeks of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    31.9 ( 12.4 )
    33.2 ( 13.0 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.99
         upper limit
    		 5.38
    Variability estimate
    Standard deviation
    Dispersion value
    1.85

    Secondary: Mean sensor glucose

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    End point title
    		 Mean sensor glucose
    End point description
    CGM assessed.
    End point type
    Secondary
    End point timeframe
    The last two week of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: mmol/L
        arithmetic mean (standard deviation)
    8.9 ( 1.0 )
    9.0 ( 1.1 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.45
    Variability estimate
    Standard deviation
    Dispersion value
    0.15

    Secondary: Standard deviation

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    End point title
    		 Standard deviation
    End point description
    cgm assessed
    End point type
    Secondary
    End point timeframe
    The last two of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: mmol/L
        arithmetic mean (standard deviation)
    3.0 ( 0.4 )
    3.2 ( 0.6 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (net)
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.37
    Variability estimate
    Standard deviation
    Dispersion value
    0.08

    Secondary: Coefficient of variation

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    End point title
    		 Coefficient of variation
    End point description
    CGM assessed
    End point type
    Secondary
    End point timeframe
    The last two weeks of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    34.0 ( 3.7 )
    35.9 ( 4.9 )
    Statistical analysis title
    		 Difference between interventions
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 3.25
    Variability estimate
    Standard deviation
    Dispersion value
    0.73

    Secondary: Glucose management index (GMI)

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    End point title
    		 Glucose management index (GMI)
    End point description
    CGM assessed
    End point type
    Secondary
    End point timeframe
    The last two weeks of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: mmol/mol
        arithmetic mean (standard deviation)
    54.4 ( 4.5 )
    55.0 ( 5.3 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 2.11
    Variability estimate
    Standard deviation
    Dispersion value
    0.7

    Secondary: Glucose risk index

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    End point title
    		 Glucose risk index
    End point description
    CGM assessed
    End point type
    Secondary
    End point timeframe
    The last two weeks of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: unit(s)
        arithmetic mean (standard deviation)
    37.0 ( 11.5 )
    41.1 ( 11.9 )
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    All analyses followed intention to treat principles, meaning all participants that were randomized after screening were included in the analyses. A linear mixed effect model with treatment and period as fixed effects and participant as random effect was used to compare the interventions.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 8.18
    Variability estimate
    Standard deviation
    Dispersion value
    2.05

    Secondary: Obtained recommendation of TIR > 70%

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    End point title
    		 Obtained recommendation of TIR > 70%
    End point description
    cgm assessed
    End point type
    Secondary
    End point timeframe
    The last two weeks of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: Number of participants
    15
    13
    Statistical analysis title
    		 BNumber of participants achivieng goal
    Statistical analysis description
    Binary outcomes were analyzed by a McNemar test or general linear regression model with mixed effects.
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 > 0.9999
    Method
    		 Mcnemar
    Parameter type
    		 Log odds ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.474
         upper limit
    		 1.48

    Secondary: Obtained recommendation TAR < 25%

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    End point title
    		 Obtained recommendation TAR < 25%
    End point description
    CGM assessed
    End point type
    Secondary
    End point timeframe
    The last two week of each treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: Number of participants
    22
    22
    Statistical analysis title
    		 Number of participants achivieng goal
    Statistical analysis description
    Binary outcomes were analyzed by a McNemar test or general linear regression model with mixed effects
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Mcnemar
    Parameter type
    		 Log odds ratio
    Point estimate
    0.099
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 1

    Secondary: Obtained recommendation of TBR < 4%

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    End point title
    		 Obtained recommendation of TBR < 4%
    End point description
    End point type
    Secondary
    End point timeframe
    The last two weeks of treatment period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: Number of participants
    36
    34
    Statistical analysis title
    		 Number of participants achivieng goal
    Statistical analysis description
    Binary outcomes were analyzed by a McNemar test or general linear regression model with mixed effects
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Mcnemar
    Parameter type
    		 Log odds ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 1.78

    Secondary: HbA1c

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    End point title
    		 HbA1c
    End point description
    End point type
    Secondary
    End point timeframe
    Taken at start and end of each intervention period
    End point values
    		 Faster aspart --> Insulin aspart Insulin Aspart --> Faster aspart
    Number of subjects analysed
    20
    20
    Units: mmol/mol
        geometric mean (standard deviation)
    57.5 ( 6.9 )
    58.0 ( 6.6 )
    Statistical analysis title
    		 Difference between interventions
    Comparison groups
    Faster aspart --> Insulin aspart v Insulin Aspart --> Faster aspart
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7421
         upper limit
    		 1.78
    Variability estimate
    Standard deviation
    Dispersion value
    0.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening to end of study, involving a total of 16 week for the first period, 16 week for the second period and more than three week for the washout.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Faster aspart
    Reporting group description
    		 16-weeks of faster aspart (Fiasp® 100 U/mL; Novo Nordisk, Bagsværd, Denmark)

    Reporting group title
    Insulin Aspart
    Reporting group description
    		 16-weeks of insulin aspart (NovoRapid® 100 U/mL; Novo Nordisk, Bagsværd, Denmark

    Serious adverse events
    		 Faster aspart Insulin Aspart
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Endocrine disorders
    SAE overall
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Faster aspart Insulin Aspart
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 40 (75.00%)
    25 / 40 (62.50%)
    Endocrine disorders
    Adverse event
         subjects affected / exposed
    30 / 40 (75.00%)
    25 / 40 (62.50%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2023
    A change in the supply of investigational medication occurred during the study. Novo Nordisk was no longer able to supply investigational medication (FiASP) for the study participants. Their clinical packaging services no longer supported FiASP, meaning they could not provide medication with an expiry date beyond March 22, 2023. Amendment to Protocol: To address this issue, the decision was made internally to purchase FiASP as commercial stock and perform the blinding procedures in-house. The sponsor and investigator thoroughly assessed this change and concluded that there was no additional risk to participants associated with the adjustment. The integrity of the blinding process was maintained under this new arrangement. Impact on Study: This amendment did not affect the primary or secondary endpoints, study design, or safety profile. The study timeline remained unchanged, with the study expected to be completed by May 30, 2023. Conclusion: This protocol amendment was implemented to ensure continuity in the supply of investigational medication while maintaining the integrity of the study. There was no impact on participant safety or study outcomes as a result of this change.

    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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