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    Clinical Trial Results:
    A phase 3b, randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus

    Summary
    EudraCT number
    		 2018-003834-34
    Trial protocol
    		 AT  
    Global end of trial date
    30 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2020
    First version publication date
    23 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZP4207-17084
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03895697
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND #: 127866
    Sponsors
    Sponsor organisation name
    Zealand Pharma A/S
    Sponsor organisation address
    Sydmarken 11, Søborg, Denmark, 2860
    Public contact
    Stine Just Maarbjerg, Zealand Pharma A/S, +45 5060 3846, SMaarbjerg@zealandpharma.com
    Scientific contact
    Ramin Tehranchi, Zealand Pharma A/S, +45 5060 3793, RTehranchi@zealandpharma.com
    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
    17 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to show non-inferiority of the efficacy of a single subcutaneous dose of dasiglucagon batch B relative to that of dasiglucagon batch A for treatment of hypoglycemia in patients with type 1 diabetes mellitus
    Protection of trial subjects
    The trial was conducted in accordance of the World Medical Association Declaration of Helsinki, current guidelines for GCP and local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Mar 2019
    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
    Austria: 25
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    Canada: 21
    Worldwide total number of subjects
    92
    EEA total number of subjects
    71
    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)
    92
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited from 4 trial centers in Austria (1 center), Canada (1 center) and Germany (2 centers) between 10 March 2019 (first patient enrolled) and 30 July 2019 (Last patient completed trial)

    Pre-assignment
    Screening details
    		 A total of 109 patients were screened of which 17 patients were not randomized.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    In order to avoid bias in patient selection and in the evaluation of clinical assessments, patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dasiglucagon Batch A crossover to Dasiglucagon Batch B
    Arm description
    		 Single treatment with Dasiglucagon Batch A followed by cross-over to a single treatment with Dasiglucagon Batch B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasiglucagon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of 0.6 mg dasiglucagon

    Arm title
    		 Dasiglucagon Batch B crossover to Dasiglucagon Batch A
    Arm description
    		 Single treatment with Dasiglucagon Batch B followed by cross-over to a single treatment with Dasiglucagon Batch A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasiglucagon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of 0.6 mg dasiglucagon

    Number of subjects in period 1
    		Dasiglucagon Batch A crossover to Dasiglucagon Batch B Dasiglucagon Batch B crossover to Dasiglucagon Batch A
    Started
    46
    46
    Treated
    45
    45
    Completed
    42
    41
    Not completed
    4
    5
         Consent withdrawn by subject
    -
    1
         Unable to come for re-scheduled dosing visit
    1
    -
         Didn't want to participate in hypo induction
    2
    1
         Adverse event, non-fatal
    -
    2
         Limited availability
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dasiglucagon Batch A crossover to Dasiglucagon Batch B
    Reporting group description
    		 Single treatment with Dasiglucagon Batch A followed by cross-over to a single treatment with Dasiglucagon Batch B.

    Reporting group title
    Dasiglucagon Batch B crossover to Dasiglucagon Batch A
    Reporting group description
    		 Single treatment with Dasiglucagon Batch B followed by cross-over to a single treatment with Dasiglucagon Batch A.

    Reporting group values
    		 Dasiglucagon Batch A crossover to Dasiglucagon Batch B Dasiglucagon Batch B crossover to Dasiglucagon Batch A Total
    Number of subjects
    		 46 46 92
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.7 ( 11.75 ) 36.3 ( 12.07 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 20 38
        Male
    		 28 26 54
    Race
    Units: Subjects
        White
    		 44 46 90
        Other
    		 2 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 45 46 91
    Body mass index class
    Units: Subjects
        < 25 kg/m^2
    		 20 21 41
        25-<30 kg/m^2
    		 22 20 42
        30-<35 kg/m^2
    		 3 3 6
        >=35 kg/m^2
    		 1 2 3
    Height
    Units: centimeter(s)
        arithmetic mean (standard deviation)
    		 175.7 ( 9.47 ) 175.1 ( 10.80 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 80.17 ( 14.662 ) 80.96 ( 17.883 ) -
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 25.82 ( 3.301 ) 26.18 ( 4.033 ) -
    Time since detection of diabetes
    Units: years
        arithmetic mean (standard deviation)
    		 19.27 ( 10.497 ) 18.44 ( 11.232 ) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomly assigned patients who had received at least 1 dose of IMP.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomly assigned patients who had received at least 1 dose of IMP.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of full analysis set who had received both treatments and had efficacy data available to evaluate the primary endpoint for both treatments. Patients could be excluded if relevant protocol deviations were documented (e.g. the use of prespecified concomitant medications).

    Subject analysis set title
    Dasiglucagon Batch A (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of per protocol analysis set that received Batch A in either arm.

    Subject analysis set title
    Dasiglucagon Batch B (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of per protocol analysis set that received Batch B in either arm.

    Subject analysis sets values
    		 Full analysis set Safety analysis set Per protocol analysis set Dasiglucagon Batch A (PP) Dasiglucagon Batch B (PP)
    Number of subjects
    90
    90
    82
    82
    82
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.5 ( 11.84 )
    36.5 ( 11.84 )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    36
    36
        Male
    54
    54
    Race
    Units: Subjects
        White
    88
    88
        Other
    2
    2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1
    1
        Not Hispanic or Latino
    89
    89
    Body mass index class
    Units: Subjects
        < 25 kg/m^2
    41
    41
        25-<30 kg/m^2
    41
    41
        30-<35 kg/m^2
    6
    6
        >=35 kg/m^2
    2
    2
    Height
    Units: centimeter(s)
        arithmetic mean (standard deviation)
    175.4 ( 10.10 )
    175.4 ( 10.10 )
    ( )
    ( )
    ( )
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    80.56 ( 16.265 )
    80.56 ( 16.265 )
    ( )
    ( )
    ( )
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    26.00 ( 3.669 )
    26.00 ( 3.669 )
    ( )
    ( )
    ( )
    Time since detection of diabetes
    Units: years
        arithmetic mean (standard deviation)
    18.86 ( 10.818 )
    18.86 ( 10.818 )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Dasiglucagon Batch A crossover to Dasiglucagon Batch B
    Reporting group description
    		 Single treatment with Dasiglucagon Batch A followed by cross-over to a single treatment with Dasiglucagon Batch B.

    Reporting group title
    Dasiglucagon Batch B crossover to Dasiglucagon Batch A
    Reporting group description
    		 Single treatment with Dasiglucagon Batch B followed by cross-over to a single treatment with Dasiglucagon Batch A.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomly assigned patients who had received at least 1 dose of IMP.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomly assigned patients who had received at least 1 dose of IMP.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of full analysis set who had received both treatments and had efficacy data available to evaluate the primary endpoint for both treatments. Patients could be excluded if relevant protocol deviations were documented (e.g. the use of prespecified concomitant medications).

    Subject analysis set title
    Dasiglucagon Batch A (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of per protocol analysis set that received Batch A in either arm.

    Subject analysis set title
    Dasiglucagon Batch B (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of per protocol analysis set that received Batch B in either arm.

    Primary: Time to plasma glucose recovery

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    End point title
    		 Time to plasma glucose recovery
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to end of trial
    End point values
    		 Dasiglucagon Batch A (PP) Dasiglucagon Batch B (PP)
    Number of subjects analysed
    82
    82
    Units: minute
        arithmetic mean (standard deviation)
    9.2 ( 2.34 )
    9.6 ( 2.89 )
    Statistical analysis title
    		 Non-inferiority of Batch B vs Batch A
    Statistical analysis description
    Time to plasma glucose recovery was analyzed by an analysis of variance (ANOVA) model, including sequence, patient within sequence, period, and treatment as factors. The 2-sided 95% CI for the treatment difference was calculated from the ANOVA model.
    Comparison groups
    Dasiglucagon Batch A (PP) v Dasiglucagon Batch B (PP)
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.403
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.078
         upper limit
    		 0.884
    Notes
    [1] - Non-inferiority of dasiglucagon Batch B relative to that of dasiglucagon Batch A was concluded as the upper limit of the 2-sided 95% CI of the treatment difference between Batch A and Batch B did not exceed δ=2 min.

    Secondary: Plasma Glucose Change from Baseline

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    End point title
    		 Plasma Glucose Change from Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to end of trial
    End point values
    		 Dasiglucagon Batch A (PP) Dasiglucagon Batch B (PP)
    Number of subjects analysed
    82
    82
    Units: milligram(s)/decilitre
    arithmetic mean (standard deviation)
        10 minutes post-dose
    24.603 ( 9.8296 )
    24.166 ( 10.9019 )
        15 minutes post-dose
    45.436 ( 13.9841 )
    44.441 ( 15.2431 )
        20 minutes post-dose
    63.423 ( 17.8243 )
    63.067 ( 17.8480 )
        30 minutes post-dose
    92.817 ( 23.2345 )
    93.999 ( 22.6758 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs and SAEs were collected from the signing of the informed consent form and until the end of the posttreatment follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Batch A
    Reporting group description
    		 Subjects from the safety analysis set that received Batch A in either arm.

    Reporting group title
    Batch B
    Reporting group description
    		 Subjects in the safety analysis set that received Batch B in either arm.

    Serious adverse events
    		 Batch A Batch B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 87 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Batch A Batch B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 87 (77.01%)
    64 / 87 (73.56%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 87 (8.05%)
    3 / 87 (3.45%)
         occurrences all number
    7
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    61 / 87 (70.11%)
    59 / 87 (67.82%)
         occurrences all number
    65
    61
    Vomiting
         subjects affected / exposed
    30 / 87 (34.48%)
    26 / 87 (29.89%)
         occurrences all number
    31
    32
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    11 / 87 (12.64%)
    11 / 87 (12.64%)
         occurrences all number
    12
    16

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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