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    Clinical Trial Results:
    A phase 3, Randomized, Double-Blind, Parallel Group Safety Trial to Evaluate the Immunogenicity of Dasiglucagon And GlucaGen® Administered Subcutaneously in patients with Type 1 Diabetes Mellitus (T1DM)

    Summary
    EudraCT number
    		 2017-000062-30
    Trial protocol
    		 DE   AT  
    Global end of trial date
    13 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Feb 2019
    First version publication date
    28 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZP4207-16136
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03216226
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: 127866
    Sponsors
    Sponsor organisation name
    Zealand Pharma A/S
    Sponsor organisation address
    Smedeland 26, Glostrup, Denmark, 2600
    Public contact
    Dorte Skydsgaard, Zealand Pharma A/S, +45 5060 3767, dsk@zealandpharma.com
    Scientific contact
    Dorte Skydsgaard, Zealand Pharma A/S, +45 5060 3767, dsk@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
    22 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon and GlucaGen following subcutaneous (s.c.) administration in T1DM patients.
    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
    15 Mar 2017
    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: 31
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Canada: 54
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    112
    EEA total number of subjects
    48
    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)
    108
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited from 7 trial centers in Austria (1 center), Canada (3 centers), Germany (1 center) and the USA (2 centers) between 28 June 2017 (first patient enrolled) and 13 February 2018 (last patient completed trial).

    Pre-assignment
    Screening details
    		 A total of 131 patients were screened of which 19 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
    Patients with T1DM were randomly assigned in a 1:1 ratio to receive 3 SC injections of either dasiglucagon (0.6 mg) or GlucaGen® (1 mg), with 1 week between doses. Since the products were not identical in appearance, unblinded trial personnel were responsible for the handling, preparation and administration of IMP.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dasiglucagon
    Arm description
    		 -
    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
    Three doses of 0.6 mg dasiglucagon (0.6 mL) given at weekly intervals.

    Arm title
    		 GlucaGen
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glucagen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Three doses of 1mg Glucagen (1mL) given at weekly intervals.

    Number of subjects in period 1
    		Dasiglucagon GlucaGen
    Started
    57
    55
    Treated
    57
    54
    Completed
    52
    50
    Not completed
    5
    5
         Adverse event, non-fatal
    3
    -
         Missed injection visit
    1
    1
         Withdrawn: veins unsuitable for blood draw
    -
    1
         Protocol deviation
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dasiglucagon
    Reporting group description
    		 -

    Reporting group title
    GlucaGen
    Reporting group description
    		 -

    Reporting group values
    		 Dasiglucagon GlucaGen Total
    Number of subjects
    		 57 55 112
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 55 53 108
        From 65-84 years
    		 2 2 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ± 12.21 38.8 ± 13.65 -
    Gender categorical
    Units: Subjects
        Female
    		 16 23 39
        Male
    		 41 32 73
    Race
    Units: Subjects
        White
    		 50 53 103
        Other
    		 7 2 9
    Height
    Units: centimetres
        arithmetic mean (standard deviation)
    		 174.1 ± 9.54 173.6 ± 7.65 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 82.9 ± 18.44 82.7 ± 16.25 -
    BMI
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 27.2 ± 4.88 27.4 ± 4.70 -
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients of the safety analysis set with at least 1 measurement of ADA titer at baseline

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

    Subject analysis sets values
    		 Full analysis set Safety analysis set
    Number of subjects
    111
    111
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    107
    107
        From 65-84 years
    4
    4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.1 ± 13.29
    42.1 ± 13.29
    Gender categorical
    Units: Subjects
        Female
    38
    38
        Male
    73
    73
    Race
    Units: Subjects
        White
    102
    102
        Other
    9
    9
    Height
    Units: centimetres
        arithmetic mean (standard deviation)
    173.9 ± 8.64
    173.9 ± 8.64
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    82.8 ± 17.33
    82.8 ± 17.33
    BMI
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    27.3 ± 4.77
    27.3 ± 4.77

    End points

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    End points reporting groups
    Reporting group title
    Dasiglucagon
    Reporting group description
    		 -

    Reporting group title
    GlucaGen
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients of the safety analysis set with at least 1 measurement of ADA titer at baseline

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

    Primary: Overall ADA

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    End point title
    		 Overall ADA [1]
    End point description
    For calculating the overall ADA incidence, patient numbers from both groups were summed and then divided by the number of evaluable patients. Baseline-positive patients without any samples available after IMP administration were excluded. Numbers and percentages of incidences in each treatment group and the incidence difference between dasiglucagon and GlucaGen® with its 95% exact confidence limits were planned to be provided but were not generated because no ADA-positive patients occurred in the trial.
    End point type
    Primary
    End point timeframe
    From baseline to end of trial
    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: Statistical analyses were planned but were not generated because no ADA-positive patients occurred in the trial.
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: Subjects
        Yes
    0
    0
    0
        No
    56
    54
    110
        Missing
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Treatment-induced ADA

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    End point title
    		 Treatment-induced ADA
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to end of trial
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: subjects
        Yes
    0
    0
    0
        No
    56
    54
    110
        Missing
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Treatment-boosted ADA

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    End point title
    		 Treatment-boosted ADA
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to end of trial
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: subjects
        Yes
    0
    0
    0
        No
    56
    54
    110
        Missing
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Incidence and titer of neutralizing activity of ADA-positive patients

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    End point title
    		 Incidence and titer of neutralizing activity of ADA-positive patients
    End point description
    This secondary immunogenicity endpoint was not analyzed since there were no overall ADA incidents in the trial population.
    End point type
    Secondary
    End point timeframe
    From baseline to end of trial
    End point values
    		 Dasiglucagon GlucaGen
    Number of subjects analysed
    57
    54
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics - Area under the plasma concentration curve (0-30 minutes)

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    End point title
    		 Pharmacokinetics - Area under the plasma concentration curve (0-30 minutes)
    End point description
    The area under the concentration-time curve from zero up to the concentration at 30 minutes. To calculate AUC the linear trapezoidal rule was used for the ascending part and the logarithmic trapezoidal rule was used for the descending part.
    End point type
    Secondary
    End point timeframe
    0-30 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: pmol.h/L
    arithmetic mean (standard deviation)
        Visit 2
    425 ± 220
    548 ± 226
    485 ± 230
        Visit 4
    499 ± 371
    546 ± 181
    522 ± 294
    No statistical analyses for this end point

    Secondary: Pharmacokinetics - Area under the plasma concentration curve (0-90 minutes)

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    End point title
    		 Pharmacokinetics - Area under the plasma concentration curve (0-90 minutes)
    End point description
    The area under the concentration-time curve from zero up to the concentration at 90 minutes. To calculate AUC the linear trapezoidal rule was used for the ascending part and the logarithmic trapezoidal rule was used for the descending part.
    End point type
    Secondary
    End point timeframe
    0-90 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: pmol.h/L
    arithmetic mean (standard deviation)
        Visit 2
    1560 ± 615
    1290 ± 434
    1430 ± 549
        Visit 4
    1640 ± 611
    1290 ± 379
    1470 ± 540
    No statistical analyses for this end point

    Secondary: Pharmacokinetics - Maximum concentration

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    End point title
    		 Pharmacokinetics - Maximum concentration
    End point description
    The measured maximum plasma concentration after administration at Visit 2 and Visit 4
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: pmol/L
    arithmetic mean (standard deviation)
        Visit 2
    1390 ± 609
    1490 ± 537
    1440 ± 574
        Visit 4
    1820 ± 2460
    1430 ± 498
    1630 ± 1790
    No statistical analyses for this end point

    Secondary: Pharmacokinetics - Time to maximum concentration

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    End point title
    		 Pharmacokinetics - Time to maximum concentration
    End point description
    The actual sampling time recorded for the maximum concentration.
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: hours
    median (full range (min-max))
        Visit 2
    0.5 (0.167 to 1.5)
    0.483 (0.0833 to 0.55)
    0.5 (0.0833 to 1.5)
        Visit 4
    0.5 (0.0833 to 1.5)
    0.5 (0.0833 to 0.517)
    0.5 (0.0833 to 1.5)
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - Area under the effect curve (0-30 minutes)

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    End point title
    		 Pharmacodynamics - Area under the effect curve (0-30 minutes)
    End point description
    The area under the baseline-adjusted effect curve from zero up to the concentration measured at 30 minutes. To calculate AUE the linear trapezoidal rule was used for the ascending part and the logarithmic trapezoidal rule was used for the descending part.
    End point type
    Secondary
    End point timeframe
    0-30 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: mmol.h/L
    arithmetic mean (standard deviation)
        Visit 2
    0.799 ± 0.449
    0.886 ± 0.504
    0.841 ± 0.476
        Visit 4
    0.869 ± 0.375
    0.895 ± 0.511
    0.881 ± 0.443
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - Area under the effect curve (0-90 minutes)

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    End point title
    		 Pharmacodynamics - Area under the effect curve (0-90 minutes)
    End point description
    The area under the baseline-adjusted effect curve from zero up to the concentration measured at 90 minutes. To calculate AUE the linear trapezoidal rule was used for the ascending part and the logarithmic trapezoidal rule was used for the descending part.
    End point type
    Secondary
    End point timeframe
    0-90 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: mmol.h/L
    arithmetic mean (standard deviation)
        Visit 2
    5.9 ± 2.42
    5.86 ± 3.14
    5.88 ± 2.78
        Visit 4
    6.47 ± 2.28
    6.04 ± 2.63
    6.26 ± 2.46
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - CEmax

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    End point title
    		 Pharmacodynamics - CEmax
    End point description
    Change from baseline plasma glucose to maximum plasma glucose measured after dosing.
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: mmol/L
    arithmetic mean (standard deviation)
        Visit 2
    6.25 ± 2.5
    6 ± 3.01
    6.12 ± 2.75
        Visit 4
    6.88 ± 2.43
    6.21 ± 2.65
    6.55 ± 2.55
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - TEmax

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    End point title
    		 Pharmacodynamics - TEmax
    End point description
    The time to reach the maximum change from baseline in plasma glucose measured after dosing.
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: hours
    median (full range (min-max))
        Visit 2
    1.5 (0.0833 to 1.57)
    1.5 (0.483 to 1.6)
    1.5 (0.0833 to 1.6)
        Visit 4
    1.5 (0.167 to 1.58)
    1.5 (0.0833 to 1.52)
    1.5 (0.0833 to 1.58)
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment - Visit 2

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    End point title
    		 Pharmacodynamics - An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment - Visit 2
    End point description
    End point type
    Secondary
    End point timeframe
    0-30 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    57
    54
    111
    Units: subjects
        Yes
    54
    51
    105
        No
    3
    3
    6
    No statistical analyses for this end point

    Secondary: Pharmacodynamics - An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment - Visit 4

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    End point title
    		 Pharmacodynamics - An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment - Visit 4
    End point description
    End point type
    Secondary
    End point timeframe
    0-30 minutes
    End point values
    		 Dasiglucagon GlucaGen Full analysis set
    Number of subjects analysed
    52
    49
    101
    Units: subjects
        Yes
    51
    47
    98
        No
    1
    2
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the first trial-related activity after the patient has signed the informed consent to the end of the follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Dasiglucagon
    Reporting group description
    		 -

    Reporting group title
    GlucaGen
    Reporting group description
    		 -

    Serious adverse events
    		 Dasiglucagon GlucaGen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dasiglucagon GlucaGen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 57 (73.68%)
    43 / 54 (79.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 57 (14.04%)
    3 / 54 (5.56%)
         occurrences all number
    14
    4
    Dizziness
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 54 (5.56%)
         occurrences all number
    2
    3
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    2 / 57 (3.51%)
    4 / 54 (7.41%)
         occurrences all number
    2
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    26 / 57 (45.61%)
    23 / 54 (42.59%)
         occurrences all number
    43
    33
    Vomiting
         subjects affected / exposed
    12 / 57 (21.05%)
    8 / 54 (14.81%)
         occurrences all number
    18
    9
    Diarrhoea
         subjects affected / exposed
    4 / 57 (7.02%)
    2 / 54 (3.70%)
         occurrences all number
    4
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    4
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    6 / 57 (10.53%)
    8 / 54 (14.81%)
         occurrences all number
    7
    9
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 57 (3.51%)
    4 / 54 (7.41%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    28 / 57 (49.12%)
    29 / 54 (53.70%)
         occurrences all number
    581
    447
    Hyperglycaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 54 (3.70%)
         occurrences all number
    3
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 May 2017
    In this substantial amendment, the following changes were made to the original protocol to revise details of the safety assessment of patients and correct changes, errors or inconsistencies in the description of the operational set up of the trial: • Clarification on the statistical method and anti-drug antibody (ADA) assays • Update of exclusion criterion on blood pressure • Update of exclusion criterion on alcohol/drug abuse • Specification of prohibited concomitant medication • Additional ECG assessment added • Clinical event of interest added • Treatment options for patients experiencing hypo- or hyperglycemia prior dosing • Monitoring of patients’ electrolyte levels • Monitoring of potential pregnancies • Additional visits required for patients discontinuing treatment prematurely • Specification on time windows for assessments • Specification of the requirements at the dosing visits • Responsibility of unblinded trial personnel • Randomization of replacement patients • Clarification to the reporting of (Serious) Adverse Events • Clarification on case report forms • Subgroup analysis added to the statistical section • Administrative changes
    21 Aug 2017
    This substantial amendment was prepared in order to investigate how pharmacodynamic and pharmacokinetic endpoints correlate with potential anti-drug antibody responses that may develop. In order to investigate this in patients that may develop antibodies late during the course of the trial, an extra visit was to be implemented for patients, who developed anti-drug antibodies after trial drug administration. The amendment also included an additional pharmacodynamic endpoint and specified that patients who discontinue the trial prematurely were not to be replaced.

    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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