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    Clinical Trial Results:
    Low-dose glucagon for Prevention of Exercise-Induced Hypoglycemia in People with Type 1 Diabetes

    Summary
    EudraCT number
    		 2021-001342-34
    Trial protocol
    		 DK  
    Global end of trial date
    31 Aug 2023

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

    Trial information

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    Trial identification
    Sponsor protocol code
    78618
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Steno Diabetes Center Copenhagen
    Sponsor organisation address
    Borgmester Ib Juuls Vej 89, Herlev, Denmark, 2730
    Public contact
    Sissel Lundemose, Steno Diabetes Center Copenhagen, +45 23742764, sissel.lundemose@regionh.dk
    Scientific contact
    Sissel Lundemose, Steno Diabetes Center Copenhagen, +45 23742764, sissel.lundemose@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
    31 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the efficacy of single-administration low-dose (150 µg) s.c. glucagon and split-administration low-dose (2 x 75 µg) s.c. glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).
    Protection of trial subjects
    NA
    Background therapy
    		 All participants used their regular treatment modality; 11 participants used insulin pump therapy and 11 participants used MDI therapy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    17
    From 65 to 84 years
    5
    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 November 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 medications 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
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The study was a single-blind study. The participants were blinded to the intervention.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 150 microgram glucagon
    Arm description
    		 Pre-exercise 150 µg s.c. glucagon and post-exercise placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    GlucaGen
    Investigational medicinal product code
    SUB02347MIG
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    150 microgram and s.c. injection

    Arm title
    		 75 microgram glucagon
    Arm description
    		 Pre-exercise 75 µg s.c. glucagon and post-exercise 75 µg s.c. glucagon
    Arm type
    		 Experimental

    Investigational medicinal product name
    GlucaGen
    Investigational medicinal product code
    SUB02347MIG
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    150 microgram and s.c. injection

    Arm title
    		 Placebo
    Arm description
    		 Pre-exercise placebo and post-exercise placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    150-75 microgram of saline injected s.c.

    Number of subjects in period 1
    		150 microgram glucagon 75 microgram glucagon Placebo
    Started
    22
    22
    22
    Completed
    22
    22
    22

    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
    		 22 22
    Age categorical
    18-64 years 65-84 years
    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)
    		 17 17
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (22 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 16 16
    BMI
    Units: kilogram(s)/square metre
        median (full range (min-max))
    		 26.3 (20.3 to 29.4) -
    Type 1 diabetes duration
    Units: Years
        median (full range (min-max))
    		 30 (2 to 63) -
    HbA1C
    Units: mmol/l
        median (full range (min-max))
    		 53 (42 to 66) -
    HbA1c
    Units: Percentage
        median (full range (min-max))
    		 7.0 (6.0 to 8.2) -
    Total daily insulin dose
    Units: unit(s)
        median (full range (min-max))
    		 39 (12 to 73) -
    Physical activities
    Units: METs/week
        median (full range (min-max))
    		 2561 (240 to 13068) -

    End points

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    End points reporting groups
    Reporting group title
    150 microgram glucagon
    Reporting group description
    		 Pre-exercise 150 µg s.c. glucagon and post-exercise placebo

    Reporting group title
    75 microgram glucagon
    Reporting group description
    		 Pre-exercise 75 µg s.c. glucagon and post-exercise 75 µg s.c. glucagon

    Reporting group title
    Placebo
    Reporting group description
    		 Pre-exercise placebo and post-exercise placebo

    Primary: Rate of hypoglycaemia (<3.9mmol/l)

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    End point title
    		 Rate of hypoglycaemia (<3.9mmol/l)
    End point description
    End point type
    Primary
    End point timeframe
    During exercise and post exercise resting phase (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: N
    7
    5
    6
    Statistical analysis title
    		 Logistic mixed effects regression model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.078
    Method
    		 Regression, Logistic
    Confidence interval

    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
    Unit: percentage point
    End point type
    Secondary
    End point timeframe
    From exercise to post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: percent
        arithmetic mean (standard error)
    3.3 ( 5.6 )
    4.1 ( 8.7 )
    5.2 ( 9.7 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.359
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: 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
    Unit: percentage point
    End point type
    Secondary
    End point timeframe
    From Exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: percent
        arithmetic mean (standard deviation)
    63.9 ( 38.9 )
    60.0 ( 34.1 )
    82.7 ( 29.6 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.845
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Mixed models analysis
    Confidence interval

    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
    Unit: Percentage point
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: Percent
        arithmetic mean (standard error)
    32.2 ( 41.3 )
    35.9 ( 36.4 )
    13.2 ( 30.2 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 150 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.027
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Time to hypoglycaemia

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    End point title
    		 Time to hypoglycaemia
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: minute
        arithmetic mean (standard deviation)
    80.0 ( 35.7 )
    46.0 ( 10.8 )
    47.5 ( 43.8 )
    Statistical analysis title
    		 Non parametric test
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49
    Method
    		 Friedmanns Non parametric test
    Confidence interval

    Secondary: Change in plasma glucose over time

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    End point title
    		 Change in plasma glucose over time
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (o-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: mmol/l
        arithmetic mean (standard deviation)
    0.03 ( 2.0 )
    0.76 ( 2.9 )
    -0.08 ( 1.8 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.419
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Mean Plasma glucose

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    End point title
    		 Mean Plasma glucose
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: mmol/l
        arithmetic mean (standard deviation)
    10.1 ( 2.8 )
    10.8 ( 3.3 )
    8.8 ( 2.6 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Copy of Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.787
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Copy of Copy of Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.076
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Copy of Copy of Copy of Generalized linear mixe...
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Hyperglycaemic events

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    End point title
    		 Hyperglycaemic events
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: N
    11
    15
    5
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.412
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.137
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Nadir

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    End point title
    		 Nadir
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: mmol/l
        arithmetic mean (standard deviation)
    6.6 ( 2.7 )
    7.0 ( 2.8 )
    6.0 ( 2.6 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.223
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Peak

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    End point title
    		 Peak
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: mmol/l
        arithmetic mean (standard deviation)
    10.1 ( 2.8 )
    10.8 ( 3.3 )
    8.8 ( 2.6 )
    Statistical analysis title
    		 generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.511
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Incemental peak

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    End point title
    		 Incemental peak
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise (0-180 min)
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: mmol/l
        arithmetic mean (standard deviation)
    2.4 ( 1.4 )
    2.7 ( 1.9 )
    1.2 ( 1.4 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.75
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: AUC

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    End point title
    		 AUC
    End point description
    End point type
    Secondary
    End point timeframe
    From exercise and post exercise
    End point values
    		 150 microgram glucagon 75 microgram glucagon Placebo
    Number of subjects analysed
    22
    22
    22
    Units: mmol/l*min
        arithmetic mean (standard deviation)
    1565.5 ( 542.8 )
    1720.9 ( 584.5 )
    1357.3 ( 497.0 )
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    150 microgram glucagon v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Generalized linear mixed model
    Comparison groups
    Placebo v 75 microgram glucagon
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    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), after exercise (t=60 min) and two hours later (t=180) to evaluate whether any adverse events had occurred within three/two hours after the intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    150 microgram glucagon (G150)
    Reporting group description
    		 -

    Reporting group title
    75*2 microgram glucagon (G75*2)
    Reporting group description
    		 -

    Reporting group title
    Placebo (PBO)
    Reporting group description
    		 -

    Serious adverse events
    		 150 microgram glucagon (G150) 75*2 microgram glucagon (G75*2) Placebo (PBO)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (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: 1%
    Non-serious adverse events
    		 150 microgram glucagon (G150) 75*2 microgram glucagon (G75*2) Placebo (PBO)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 22 (18.18%)
    5 / 22 (22.73%)
    7 / 22 (31.82%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    1
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    4 / 22 (18.18%)
    3 / 22 (13.64%)
    5 / 22 (22.73%)
         occurrences all number
    5
    4
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1

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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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