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    Clinical Trial Results:
    Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes

    Summary
    EudraCT number
    		 2015-003252-40
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Jan 2015

    Results information
    Results version number
    		 v1
    This version publication date
    22 Oct 2017
    First version publication date
    22 Oct 2017
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    I8R-MC-IGBB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01997411
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: I8R-MC-IGBB, Trial Number : 16418, Additional Trial Identifier: AMG103
    Sponsors
    Sponsor organisation name
    Jaeb Center for Health Research
    Sponsor organisation address
    15310 Amberly Drive, Tampa, United States,
    Public contact
    Study Principal Investigator, Jaeb Center for Health Research, kruedy@jaeb.org
    Scientific contact
    Study Principal Investigator, Jaeb Center for Health Research, kruedy@jaeb.org
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST , Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST , Eli Lilly and Company, 1 877-285-4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001657-PIP01-14
    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
    13 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to assess how glucagon administered as a puff into the nose (AMG504-1) works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given as a puff into the nose was evaluated.
    Protection of trial subjects
    Guidelines as drawn up by the institutional review board were followed with regard to the treatment of human subjects in the study. These guidelines meet the requirements of the Declaration of Helsinki; they also meet the requirements of the United States Code of Federal Regulations (Title 21, Part 56), the Directive 2001/20/EC (Europe) and the Tri-Council Policy Statement (Canada). This study was performed in compliance with Good Clinical Practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2013
    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
    United States: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    0
    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)
    35
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Entered

    Pre-assignment
    Screening details
    		 No Text Entered

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 4 to<8 Years Old Intramuscular Glucagon Visit
    Arm description
    		 Participants who weighed at least 25 kilograms (kg) were dosed 1 milligram (mg) of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1milliliter (mL) of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Intramuscular Glucagon
    Investigational medicinal product code
    Other name
    Glucagon, GlucaGen HypoKit
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.

    Arm title
    		 4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit
    Arm description
    		 At the first visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intranasal Glucagon
    Investigational medicinal product code
    Other name
    AMG504-1
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the first visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Arm title
    		 4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit
    Arm description
    		 At the first visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intranasal Glucagon
    Investigational medicinal product code
    Other name
    AMG504-1
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the first visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Arm title
    		 8 to <12 Years Old Intramuscular Glucagon Visit
    Arm description
    		 Participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Intramuscular Glucagon
    Investigational medicinal product code
    Other name
    Glucagon, GlucaGen HypoKit
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.

    Arm title
    		 8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit
    Arm description
    		 At the first visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intranasal Glucagon
    Investigational medicinal product code
    Other name
    AMG504-1
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the first visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Arm title
    		 8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit
    Arm description
    		 At the first visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intranasal Glucagon
    Investigational medicinal product code
    Other name
    AMG504-1
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the first visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Arm title
    		 12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit
    Arm description
    		 At the first visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagonUSP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Intramuscular Glucagon
    Investigational medicinal product code
    Other name
    Glucagon, GlucaGen HypoKit
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    At the first visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.

    Investigational medicinal product name
    Intranasal Glucagon
    Investigational medicinal product code
    Other name
    AMG504-1
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the first visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.

    Arm title
    		 12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 2nd Visit
    Arm description
    		 At the first visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. At the second visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Intramuscular Glucagon
    Investigational medicinal product code
    Other name
    Glucagon, GlucaGen HypoKit
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    At the first visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. At the second visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Investigational medicinal product name
    Intranasal Glucagon
    Investigational medicinal product code
    Other name
    AMG504-1
    Pharmaceutical forms
    Nasal powder
    Routes of administration
    Intranasal use
    Dosage and administration details
    At the first visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. At the second visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Number of subjects in period 1
    		4 to<8 Years Old Intramuscular Glucagon Visit 4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit 4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit 8 to <12 Years Old Intramuscular Glucagon Visit 8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit 8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit 12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit 12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 2nd Visit
    Started
    6
    6
    6
    6
    6
    6
    6
    6
    Completed
    6
    6
    6
    6
    6
    5
    6
    6
    Not completed
    0
    0
    0
    0
    0
    1
    0
    0
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    1
    -
    -

    Baseline characteristics

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

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 48 48
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.2 ( 3.5 ) -
    Gender, Male/Female
    Units:
        Female
    		 16 16
        Male
    		 32 32
    Region of Enrollment
    Units: Subjects
        United States
    		 48 48
    Duration of Diabetes
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 3.9 (2.6 to 6) -
    Local HbA1c (glycated haemoglobin)
    Units: Percentage
        arithmetic mean (standard deviation)
    		 8 ( 1 ) -
    Subject analysis sets

    Subject analysis set title
    4 to<8 Years Old Intramuscular Glucagon
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.

    Subject analysis set title
    4 to<8 Years Old Intranasal Glucagon 2mg then 3mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 then 3.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    4 to<8 Years Old Intranasal Glucagon 3mg then 2mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 3.0 then 2.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    8 to <12 Intramuscular Glucagon
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.

    Subject analysis set title
    8 to <12 Years Old Intranasal Glucagon 2mg then 3mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 then 3.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    8 to <12 Years Old Intranasal Glucagon 3mg then 2mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 3.0 then 2.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    12 to <17 Years Old Intranasal then Intramuscular Glucagon
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive intranasal glucagon then intramuscular glucagon at two separate visits.

    Subject analysis set title
    12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive intramuscular glucagon then intranasal glucagon at two separate visits.

    Subject analysis sets values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects
    6
    12
    12
    6
    12
    12
    12
    12
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    6.1 ( 1.6 )
    6.7 ( 1 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender, Male/Female
    Units:
        Female
    0
    3
        Male
    6
    9
    Region of Enrollment
    Units: Subjects
        United States
    6
    12
    Duration of Diabetes
    Units: years
        median (inter-quartile range (Q1-Q3))
    3.1 (2.1 to 3.8)
    2.7 (1.8 to 3.6)
    Local HbA1c (glycated haemoglobin)
    Units: Percentage
        arithmetic mean (standard deviation)
    7.6 ( 0.5 )
    8.3 ( 0.8 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    4 to<8 Years Old Intramuscular Glucagon Visit
    Reporting group description
    		 Participants who weighed at least 25 kilograms (kg) were dosed 1 milligram (mg) of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1milliliter (mL) of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.

    Reporting group title
    4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit
    Reporting group description
    		 At the first visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Reporting group title
    4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit
    Reporting group description
    		 At the first visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Reporting group title
    8 to <12 Years Old Intramuscular Glucagon Visit
    Reporting group description
    		 Participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.

    Reporting group title
    8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit
    Reporting group description
    		 At the first visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Reporting group title
    8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit
    Reporting group description
    		 At the first visit, a glucagon dose of 3.0 mg for participants 4 to less than 8 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, a glucagon dose of 2.0 mg for participants 4 to less than 8 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Reporting group title
    12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit
    Reporting group description
    		 At the first visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation. At the second visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagonUSP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.

    Reporting group title
    12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 2nd Visit
    Reporting group description
    		 At the first visit, participants who weighed at least 25 kg were dosed 1 mg of recombinant human glucagon USP which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. At the second visit, a glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

    Subject analysis set title
    4 to<8 Years Old Intramuscular Glucagon
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.

    Subject analysis set title
    4 to<8 Years Old Intranasal Glucagon 2mg then 3mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 then 3.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    4 to<8 Years Old Intranasal Glucagon 3mg then 2mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 3.0 then 2.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    8 to <12 Intramuscular Glucagon
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.

    Subject analysis set title
    8 to <12 Years Old Intranasal Glucagon 2mg then 3mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 then 3.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    8 to <12 Years Old Intranasal Glucagon 3mg then 2mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 3.0 then 2.0 mg of intranasal glucagon at two separate visits.

    Subject analysis set title
    12 to <17 Years Old Intranasal then Intramuscular Glucagon
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive intranasal glucagon then intramuscular glucagon at two separate visits.

    Subject analysis set title
    12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive intramuscular glucagon then intranasal glucagon at two separate visits.

    Primary: Percentage of Participants with ≥ 25 mg/dL Rise in Plasma Glucose

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    End point title
    		 Percentage of Participants with ≥ 25 mg/dL Rise in Plasma Glucose [1]
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Primary
    End point timeframe
    0 to 20 minutes following administration of glucagon
    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: Inferential statistics were calculated only as exploratory analysis for the maximum observed concentration (Cmax).
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Primary: Maximum Observed Concentration (Cmax) of Glucagon

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    End point title
    		 Maximum Observed Concentration (Cmax) of Glucagon
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Primary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: picogram per milliliter (pg/mL)
        arithmetic mean (standard deviation)
    6343 ( 2029 )
    3531 ( 1762 )
    4033 ( 2435 )
    4817 ( 3086 )
    2952 ( 1024 )
    5832 ( 2106 )
    4382 ( 3771 )
    3186 ( 2294 )
    Statistical analysis title
    		 Cmax (2mg versus 3mg; 4 to 8 Years Old)
    Comparison groups
    4 to<8 Years Old Intranasal Glucagon 2mg then 3mg v 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9333
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Cmax (IM versus 3mg; 4 to 8 Years Old)
    Comparison groups
    4 to<8 Years Old Intramuscular Glucagon v 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1156
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Cmax (2mg versus 3mg; 8 to 12 Years Old)
    Comparison groups
    8 to <12 Years Old Intranasal Glucagon 2mg then 3mg v 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0027
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Cmax (IM versus 3mg; 8 to 12 Years Old)
    Comparison groups
    8 to <12 Intramuscular Glucagon v 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3599
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Cmax (IM versus 3mg; 12 to 17 Years Old)
    Comparison groups
    12 to <17 Years Old Intramuscular Glucagon then Intranasal v 12 to <17 Years Old Intranasal then Intramuscular Glucagon
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1229
    Method
    		 ANOVA
    Confidence interval

    Primary: Time to Maximum Concentration (Tmax) of glucagon

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    End point title
    		 Time to Maximum Concentration (Tmax) of glucagon [2]
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Primary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    Notes
    [2] - 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: Inferential statistics were calculated only as exploratory analysis for the maximum observed concentration (Cmax).
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: minutes
        arithmetic mean (inter-quartile range (Q1-Q3))
    17 (5 to 30)
    15 (10 to 20)
    17 (10 to 60)
    17 (5 to 30)
    15 (10 to 20)
    15 (10 to 30)
    17 (5 to 30)
    20 (15 to 30)
    No statistical analyses for this end point

    Secondary: Area Under the Curve from Time Zero to the Last Quantifiable Concentration (AUC0-t) of Glucagon

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    End point title
    		 Area Under the Curve from Time Zero to the Last Quantifiable Concentration (AUC0-t) of Glucagon
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    0 to 90 minutes following administration of glucagon
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: hour (hr) per pg/mL
        arithmetic mean (standard deviation)
    4158.18 ( 2051.23 )
    1844.86 ( 99.2 )
    2583.9 ( 1426.27 )
    3747.02 ( 2051.71 )
    1767.92 ( 683.33 )
    3191.44 ( 1139.19 )
    3267.09 ( 2841.57 )
    2123.19 ( 1318.94 )
    No statistical analyses for this end point

    Secondary: Nasal and Non-Nasal Effects/Symptoms

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    End point title
    		 Nasal and Non-Nasal Effects/Symptoms
    End point description
    Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat will be assessed 15, 30, 60 and 90 minutes following administration of glucagon. This is done via the "Nasal Non-nasal Score Questionnaire". Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each subject and reporting the median/ interquartile range across participants). Analysis Population Description: One participant in the 8 to <12 group withdrew from the study after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    Timepoints of 15 minutes, 30 minutes, 60 minutes, and 90 minutes post glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    12
    12
    6
    11
    12
    12
    12
    Units: units on a scale
    median (inter-quartile range (Q1-Q3))
        Visit Arrival
    0.5 (0 to 1)
    0 (0 to 2)
    0 (0 to 1)
    0 (0 to 0)
    0 (0 to 1)
    0 (0 to 0.5)
    0 (0 to 0.5)
    0.5 (0 to 1)
        15 minutes post glucagon administration
    0 (0 to 1)
    1 (0 to 3)
    0.5 (0 to 2)
    0 (0 to 1)
    3 (0 to 4)
    3 (1 to 4.5)
    0 (0 to 0)
    2 (1 to 4)
        30 minutes post glucagon administration
    0 (0 to 1)
    1 (0 to 1.5)
    0.5 (0 to 1.5)
    0 (0 to 1)
    2 (0 to 2)
    2.5 (0.5 to 3.5)
    0 (0 to 0)
    1 (1 to 3)
        60 minutes post glucagon administration
    0 (0 to 0)
    0.5 (0 to 2)
    0 (0 to 1)
    0 (0 to 0)
    0 (0 to 1)
    0.5 (0 to 1.5)
    0 (0 to 0)
    1 (0 to 2)
        90 minutes post glucagon administration
    0 (0 to 0)
    0 (0 to 1.5)
    0 (0 to 0.5)
    0 (0 to 0)
    0 (0 to 1)
    0 (0 to 1)
    0 (0 to 0)
    1 (0 to 1)
    No statistical analyses for this end point

    Secondary: Maximum concentration (Cmax) of glucose

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    End point title
    		 Maximum concentration (Cmax) of glucose
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: mg/dL
        arithmetic mean (standard deviation)
    210.33 ( 28.08 )
    188.36 ( 51.55 )
    207 ( 43.27 )
    205.33 ( 24.34 )
    201.27 ( 27.95 )
    205.83 ( 31.98 )
    193.83 ( 33.32 )
    178.17 ( 27.27 )
    No statistical analyses for this end point

    Secondary: Time to Maximum Concentration (Tmax) of Glucose

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    End point title
    		 Time to Maximum Concentration (Tmax) of Glucose
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: hours
        median (full range (min-max))
    1 (0.67 to 1.5)
    0.67 (0.33 to 1)
    1 (0.5 to 1.5)
    1.5 (1 to 1.5)
    1 (0.67 to 1.5)
    1 (0.5 to 1.5)
    1 (0.67 to 1.5)
    1 (0.5 to 1.5)
    No statistical analyses for this end point

    Secondary: Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Glucose from Time Zero up to 90 Minutes

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    End point title
    		 Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Glucose from Time Zero up to 90 Minutes
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: hr.mg/dL
        arithmetic mean (standard deviation)
    254.07 ( 32.75 )
    223.45 ( 69.43 )
    246.51 ( 54.4 )
    244.46 ( 27.51 )
    243.06 ( 34.4 )
    247.5 ( 39.39 )
    232.86 ( 39.63 )
    215.02 ( 29.29 )
    No statistical analyses for this end point

    Secondary: Number and 99% Confidence Interval of Participants Achieving at least a 25 mg/dl Rise in Blood Glucose above Basal Level

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    End point title
    		 Number and 99% Confidence Interval of Participants Achieving at least a 25 mg/dl Rise in Blood Glucose above Basal Level
    End point description
    One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: number of participants
        number (confidence interval 99%)
    1 (0.4 to 1)
    1 (0.6 to 1)
    1 (0.6 to 1)
    1 (0.4 to 1)
    1 (0.6 to 1)
    1 (0.6 to 1)
    1 (0.6 to 1)
    1 (0.6 to 1)
    No statistical analyses for this end point

    Secondary: Time to Achieving ≥25 mg/dl Rise in Plasma Glucose above Basal Level

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    End point title
    		 Time to Achieving ≥25 mg/dl Rise in Plasma Glucose above Basal Level
    End point description
    Time (in minutes) when all participants experienced a rise in glucose >=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort. Analysis Population Description: One participant in the 4 to <8 year old 2.0 mg Intranasal Glucagon group was excluded since the participant did not receive glucagon due to blowing nose after IN administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    End point type
    Secondary
    End point timeframe
    0 to 90 minutes following glucagon administration.
    End point values
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2mg then 3mg 4 to<8 Years Old Intranasal Glucagon 3mg then 2mg 8 to <12 Intramuscular Glucagon 8 to <12 Years Old Intranasal Glucagon 2mg then 3mg 8 to <12 Years Old Intranasal Glucagon 3mg then 2mg 12 to <17 Years Old Intranasal then Intramuscular Glucagon 12 to <17 Years Old Intramuscular Glucagon then Intranasal
    Number of subjects analysed
    6
    11
    12
    6
    11
    12
    12
    12
    Units: minutes
        number (not applicable)
    10
    20
    15
    20
    20
    15
    20
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    One participant in the 8 to <12 group withdrew from the study after completion of the 3.0 mg Intranasal Glucagon visit and did not complete the 2.0 mg Intranasal Glucagon visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1 & 17
    Reporting groups
    Reporting group title
    4 to<8 Years Old Intramuscular Glucagon
    Reporting group description
    		 -

    Reporting group title
    4 to<8 Years Old Intranasal Glucagon 2.0 mg
    Reporting group description
    		 -

    Reporting group title
    4 to<8 Years Old Intranasal Glucagon 3.0 mg
    Reporting group description
    		 -

    Reporting group title
    8 to <12 Years Old Intramuscular Glucagon
    Reporting group description
    		 -

    Reporting group title
    8 to<12 Years Old Intranasal Glucagon 2.0mg
    Reporting group description
    		 -

    Reporting group title
    8 to<12 Years Old Intranasal Glucagon 3.0mg
    Reporting group description
    		 -

    Reporting group title
    12 to <17 Years Old Intramuscular Glucagon
    Reporting group description
    		 -

    Reporting group title
    12 to<17 Years Old Intranasal Glucagon 3.0mg
    Reporting group description
    		 -

    Serious adverse events
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2.0 mg 4 to<8 Years Old Intranasal Glucagon 3.0 mg 8 to <12 Years Old Intramuscular Glucagon 8 to<12 Years Old Intranasal Glucagon 2.0mg 8 to<12 Years Old Intranasal Glucagon 3.0mg 12 to <17 Years Old Intramuscular Glucagon 12 to<17 Years Old Intranasal Glucagon 3.0mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    Hypoglycemia
    Additional description: Experienced a hypoglycemic event after receiving a bolus of insulin with lunch. Received 90 grams oral carbohydrates and made a full recovery.
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 4 to<8 Years Old Intramuscular Glucagon 4 to<8 Years Old Intranasal Glucagon 2.0 mg 4 to<8 Years Old Intranasal Glucagon 3.0 mg 8 to <12 Years Old Intramuscular Glucagon 8 to<12 Years Old Intranasal Glucagon 2.0mg 8 to<12 Years Old Intranasal Glucagon 3.0mg 12 to <17 Years Old Intramuscular Glucagon 12 to<17 Years Old Intranasal Glucagon 3.0mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    6 / 12 (50.00%)
    5 / 12 (41.67%)
    6 / 6 (100.00%)
    5 / 11 (45.45%)
    6 / 12 (50.00%)
    7 / 12 (58.33%)
    9 / 12 (75.00%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Injection site discomfort
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 6 (50.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    3
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Lacrimation increase
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Ocular discomfort
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    Diarrhea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    4 / 6 (66.67%)
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    3 / 6 (50.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
         occurrences all number
    4
    4
    2
    3
    1
    1
    1
    2
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    3 / 6 (50.00%)
    3 / 11 (27.27%)
    4 / 12 (33.33%)
    5 / 12 (41.67%)
    4 / 12 (33.33%)
         occurrences all number
    1
    1
    3
    3
    3
    4
    5
    4
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Nasal discomfort
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Rhinalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    2 / 6 (33.33%)
    2 / 11 (18.18%)
    4 / 12 (33.33%)
    1 / 12 (8.33%)
    4 / 12 (33.33%)
         occurrences all number
    0
    2
    1
    2
    2
    4
    1
    4

    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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