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    Clinical Trial Results:
    The impact of subcutaneous glucagon before, during and after exercise. A study in patients with type 1 diabetes mellitus

    Summary
    EudraCT number
    		 2016-002127-28
    Trial protocol
    		 DK  
    Global end of trial date
    07 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2019
    First version publication date
    22 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16016762
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hvidovre Univeraity Hospital
    Sponsor organisation address
    Kettegård Allé 30, Hvidovre, Denmark, 2650
    Public contact
    Isabelle, Hvidovre University Hospital, +45 51519085, Isabelle.Isa.Kristin.Steineck@regionh.dk
    Scientific contact
    Isabelle, Hvidovre University Hospital, +45 51519085, Isabelle.Isa.Kristin.Steineck@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
    Interim
    Date of interim/final analysis
    29 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes.
    Protection of trial subjects
    1. Visual analogue score to collect data on nausea, pain, sweating and heartbeats 2. If a subject would have had a low blood glucose under 2.5 mmol/l then we would have stopped the trial
    Background therapy
    		 Continuous subcutaneous insulin pump therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jul 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    13
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from the outpatient diabetes clinic at Copenhagen University Hospital in Hvidovre in the period September 2016 to May 2017.

    Pre-assignment
    Screening details
    		 The screening was performed after an overnight fast. Information was collected on sex, age, race, diabetes duration, allergies, medical history and medications; height, weight, blood pressure and heart rate were measured; questionnaires to identify hypoglycemia unawareness were filled out and a 12-lead electrocardiography.

    Pre-assignment period milestones
    Number of subjects started
    		 18 [1]
    Number of subjects completed
    		 14

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Pregnancy: 1
    Reason: Number of subjects
    		 Lack of time: 3
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: I includet 18 but only 14 completed
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Glucagon after Cycling
    Arm description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of cycling. A subcutaneous injection of 200 µg glucagon was given after cycling and frequent blood sampling occurred until two hours after exercise.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GlucaGen
    Investigational medicinal product code
    SUB02347MIG
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 micro gram given subcutaneously in abdominal wall given one time after 45 minutes of cycling

    Arm title
    		 Glucagon after Resting
    Arm description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of resting. A subcutaneous injection of 200 µg glucagon was given after resting and frequent blood sampling occurred until two hours after the injection of glucagon.
    Arm type
    		 control

    Investigational medicinal product name
    GlucaGen
    Investigational medicinal product code
    SUB02347MIG
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 micro gram given subcutaneously in abdominal wall given one time after 45 minutes of resting

    Arm title
    		 Glucagon before cycling
    Arm description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of cycling. A subcutaneous injection of 200 µg glucagon was given before cycling and frequent blood sampling occurred until two hours after exercise.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GlucaGen
    Investigational medicinal product code
    SUB02347MIG
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 micro gram given subcutaneously in abdominal wall given one time before 45 minutes of cycling

    Number of subjects in period 1
    		Glucagon after Cycling Glucagon after Resting Glucagon before cycling
    Started
    14
    14
    13
    Completed
    14
    14
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Fourteen insulin pump-treated individuals with type 1 diabetes completed three visits in a randomized, placebo-controlled, single-blinded crossover study. Baseline (mean and range) HbA1c 54 (43-65) mmol/mol or 7.1 (6.1-8.1) %, age 45 (23-66) years, BMI 26 (21-30) kg/m2, diabetes duration 26 (8-51) years.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 14 14
    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)
    		 13 13
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 45 (23 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 8 8
    Subject analysis sets

    Subject analysis set title
    Primary endpoint
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subjects in the study

    Subject analysis sets values
    		 Primary endpoint
    Number of subjects
    14
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    13
        From 65-84 years
    1
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Glucagon after Cycling
    Reporting group description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of cycling. A subcutaneous injection of 200 µg glucagon was given after cycling and frequent blood sampling occurred until two hours after exercise.

    Reporting group title
    Glucagon after Resting
    Reporting group description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of resting. A subcutaneous injection of 200 µg glucagon was given after resting and frequent blood sampling occurred until two hours after the injection of glucagon.

    Reporting group title
    Glucagon before cycling
    Reporting group description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of cycling. A subcutaneous injection of 200 µg glucagon was given before cycling and frequent blood sampling occurred until two hours after exercise.

    Subject analysis set title
    Primary endpoint
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subjects in the study

    Primary: The glucose response to glucagon when glucagon was given after cycling compared with after resting

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    End point title
    		 The glucose response to glucagon when glucagon was given after cycling compared with after resting [1]
    End point description
    End point type
    Primary
    End point timeframe
    120 minutes after the injection of glucagon
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not applicable -please see article for further details
    End point values
    		 Glucagon after Cycling Glucagon after Resting
    Number of subjects analysed
    14
    14
    Units: mmol/l
        number (not applicable)
    2.6
    1.8
    Statistical analysis title
    		 Primary outcome
    Statistical analysis description
    A paired t-test was used to compare the logarithmic incremental peak plasma glucose after cycling with after resting.
    Comparison groups
    Glucagon after Cycling v Glucagon after Resting
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.02
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [2] - Obs: This was a crossover study so the number of subjects was not 28 but 14 because it was the same subjects who did the 2 arms.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    120 minutes after the glucagon injection
    Adverse event reporting additional description
    Visual analogue scale given after the glucagon injection that was done in clinic
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Visual analogue scal
    Dictionary version
    na
    Reporting groups
    Reporting group title
    Glucagon after Cycling
    Reporting group description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of cycling. A subcutaneous injection of 200 µg glucagon was given after cycling and frequent blood sampling occurred until two hours after exercise.

    Reporting group title
    Glucagon after Resting
    Reporting group description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of resting. A subcutaneous injection of 200 µg glucagon was given after resting and frequent blood sampling occurred until two hours after the injection of glucagon.

    Reporting group title
    Glucagon before cycling
    Reporting group description
    		 Participants consumed a standardized breakfast two hours prior to 45 minutes of cycling. A subcutaneous injection of 200 µg glucagon was given before cycling and frequent blood sampling occurred until two hours after exercise.

    Serious adverse events
    		 Glucagon after Cycling Glucagon after Resting Glucagon before cycling
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Glucagon after Cycling Glucagon after Resting Glucagon before cycling
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    Gastrointestinal disorders
    Nausea
    Additional description: One participant consistently reported nausea (mean VAS increased 2.83 cm) after glucagon injection in all three study visits.
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Nov 2016
    1. We included subjects with age op to 70 years old instead of age op to 65 years old. 2. In the first version of the protocol we included participants with ” Sedentary or mild physical activity: Less than 150 minutes of moderate-intensity aerobic physical activity throughout the week and less than 75 minutes of vigorous-intensity aerobic physical activity throughout the week .” We deleted this inclusion criteria this 3. We added a new exclusion criteria: We added: ”People with vigorous intensity aerobic physical activity such as swimming, jogging, aerobics, football, tennis, gym, workout etc, more than 3 hours or more per week. “

    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.
    Not applicable. See article for details.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30643924
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