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    Clinical Trial Results:
    A phase 3, randomized, double-blind, parallel trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo and with reference to GlucaGen®

    Summary
    EudraCT number
    		 2017-002449-31
    Trial protocol
    		 DE   AT  
    Global end of trial date
    25 May 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ZP4207-16137
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03378635
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand Pharma A/S
    Sponsor organisation address
    Sydmarken 11, Søborg, Denmark, 2860
    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
    27 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous 0.6 mg dose administered to subjects with type 1 diabetes mellitus with insulin-induced hypoglycemia.
    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
    01 Dec 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: 68
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Canada: 38
    Country: Number of subjects enrolled
    United States: 24
    Worldwide total number of subjects
    170
    EEA total number of subjects
    108
    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)
    164
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited from five trial centers; two in Germany and one each in Austria, Canada and the US.

    Pre-assignment
    Screening details
    		 A total of 235 patients were screened of which 170 patients were 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
    The subjects were randomized 2:1:1 to receive a single fixed SC 0.6 mg dose of dasiglucagon, placebo, or a 1 mg dose of GlucaGen. 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
    A single dose of 0.6 mg dasiglucagon (0.6 mL).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of placebo (0.6 mL).

    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
    A single dose of 1mg Glucagen (1mL).

    Number of subjects in period 1
    		Dasiglucagon Placebo GlucaGen
    Started
    84
    43
    43
    Treated
    82
    43
    43
    Completed
    82
    43
    43
    Not completed
    2
    0
    0
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    -

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    GlucaGen
    Reporting group description
    		 -

    Reporting group values
    		 Dasiglucagon Placebo GlucaGen Total
    Number of subjects
    		 84 43 43 170
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.2 ± 12.1 38.0 ± 13.1 40.2 ± 11.5 -
    Gender categorical
    Units: Subjects
        Female
    		 32 16 15 63
        Male
    		 50 27 28 105
        Not recorded
    		 2 0 0 2
    Race
    Units: Subjects
        White
    		 76 39 39 154
        Other
    		 6 4 4 14
        Not recorded
    		 2 0 0 2
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 78.3 ± 13.5 79.6 ± 13.0 80.7 ± 15.1 -
    Height
    Units: centimeter
        arithmetic mean (standard deviation)
    		 173.1 ± 9.44 174.2 ± 9.15 175.9 ± 9.71 -
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 26.1 ± 4.13 26.1 ± 3.34 25.9 ± 3.42 -
    HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    		 7.52 ± 0.95 7.17 ± 0.74 7.41 ± 0.97 -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of trial medication.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least one dose of trial medication.

    Subject analysis sets values
    		 Full Analysis Set Safety Analysis Set
    Number of subjects
    168
    168
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.1 ± 12.2
    39.1 ± 12.2
    Gender categorical
    Units: Subjects
        Female
    63
    63
        Male
    105
    105
        Not recorded
    Race
    Units: Subjects
        White
    154
    154
        Other
    14
    14
        Not recorded
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    79.2 ± 13.7
    79.2 ± 13.7
    Height
    Units: centimeter
        arithmetic mean (standard deviation)
    174.1 ± 9.45
    174.1 ± 9.45
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    26.1 ± 3.75
    26.1 ± 3.75
    HbA1c
    Units: percent
        arithmetic mean (standard deviation)
    7.40 ± 0.91
    7.40 ± 0.91

    End points

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

    Reporting group title
    Placebo
    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 randomized patients who received at least one dose of trial medication.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who received at least one dose of trial medication.

    Primary: Time to plasma glucose recovery

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    End point title
    		 Time to plasma glucose recovery
    End point description
    plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue IV glucose. If recovery had not occurred at 45 minutes after investigational product injection, censoring was applied irrespective of the use of rescue IV glucose.
    End point type
    Primary
    End point timeframe
    Time from administration/baseline
    End point values
    		 Dasiglucagon Placebo GlucaGen
    Number of subjects analysed
    82
    43
    43
    Units: minutes
        median (confidence interval 95%)
    10 (10 to 10)
    40 (30 to 40)
    12 (10 to 12)
    Statistical analysis title
    		 log-rank test: Dasiglucagon versus placebo
    Statistical analysis description
    The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test.
    Comparison groups
    Placebo v Dasiglucagon
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Confidence interval

    Secondary: Plasma glucose recovery at defined times

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    End point title
    		 Plasma glucose recovery at defined times
    End point description
    End point type
    Secondary
    End point timeframe
    time from administration/baseline
    End point values
    		 Dasiglucagon Placebo GlucaGen
    Number of subjects analysed
    82
    43
    43
    Units: subjects
        Glucose recovery at 30 minutes
    82
    20
    43
        Glucose recovery at 20 minutes
    81
    6
    42
        Glucose recovery at 15 minutes
    81
    1
    41
        Glucose recovery at 10 minutes
    53
    0
    21
    Statistical analysis title
    		 Fisher's Exact test: Dasiglucagon versus placebo
    Statistical analysis description
    Pairwise test of independent binomial proportions with Fisher's Exact test comparing Dasiglucagon versus Placebo. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing Dasiglucagon versus Placebo.
    Comparison groups
    Dasiglucagon v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - p-value was <0.001 at all time points (10, 15, 20 and 30 minutes)

    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
    Time from administration/baseline
    End point values
    		 Dasiglucagon Placebo GlucaGen
    Number of subjects analysed
    82
    43
    43
    Units: mg/dL
    arithmetic mean (standard deviation)
        At 30 minutes
    90.9 ± 18.2
    19.1 ± 13.0
    88.5 ± 19.2
        At 20 minutes
    59.7 ± 15.0
    8.7 ± 10.8
    58.4 ± 15.6
        At 15 minutes
    43.5 ± 12.51
    6.65 ± 6.82
    44.1 ± 14.0
        At 10 minutes
    23.9 ± 9.84
    -0.14 ± 5.65
    22.0 ± 10.0
    Statistical analysis title
    		 Least squares means: Dasiglucagon versus Placebo
    Statistical analysis description
    This key secondary endpoint was analyzed with the plasma glucose change from baseline at rescue carried forward in those patients who required rescue IV glucose before plasma glucose ≥20 mg/dL recovery. Each of these change from baseline variables was analyzed using an ANCOVA model, with treatment group modeled as a fixed effect and with the baseline plasma glucose modeled as a covariate. The group difference was evaluated inferentially until the first failure to reject, starting at 30 minutes.
    Comparison groups
    Dasiglucagon v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - The p-value was <0.001 at all time points (10, 15, 20 and 30 minutes).

    Secondary: Time to First Plasma Glucose Concentration ≥70 mg/dL

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    End point title
    		 Time to First Plasma Glucose Concentration ≥70 mg/dL
    End point description
    Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue IV glucose. If the ≥70 mg/dL endpoint was not met within 45 minutes post-dosing, the time of the last valid plasma glucose measurement up to 45 minutes was the censoring time.
    End point type
    Secondary
    End point timeframe
    Time from administration/baseline
    End point values
    		 Dasiglucagon Placebo GlucaGen
    Number of subjects analysed
    82
    43
    43
    Units: minute
        median (confidence interval 95%)
    8 (8 to 8)
    25 (20 to 30)
    8 (8 to 10)
    Statistical analysis title
    		 Least squares means: Dasiglucagon versus Placebo
    Statistical analysis description
    The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% CI, p-value based on a pairwise two-sided log-rank test versus placebo.
    Comparison groups
    Dasiglucagon v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Confidence interval

    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
    End point type
    Secondary
    End point timeframe
    Time from administration/baseline
    End point values
    		 Dasiglucagon Placebo GlucaGen
    Number of subjects analysed
    82
    43
    43
    Units: mg.h/dL
        arithmetic mean (standard deviation)
    21.0 ± 5.26
    3.57 ± 2.86
    20.4 ± 5.49
    Statistical analysis title
    		 Least squares means: Dasiglucagon versus Placebo
    Statistical analysis description
    The log-transformed AUC endpoint is analyzed using an ANCOVA model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences will be back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% CI.
    Comparison groups
    Dasiglucagon v Placebo
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean
    Point estimate
    0.131
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.171

    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) [3]
    End point description
    The area under the concentration-time curve from zero up to the concentration at 90 minutes. To calculate AUC the standard trapezoidal method was used, based on actual rather than nominal time points.
    End point type
    Secondary
    End point timeframe
    0-90 minutes
    Notes
    [3] - 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: No results are presented for the placebo group, as no drug was given in this group.
    End point values
    		 Dasiglucagon GlucaGen
    Number of subjects analysed
    82
    43
    Units: pmol.h/L
        arithmetic mean (standard deviation)
    1520 ± 518
    1350 ± 372
    Statistical analysis title
    		 Least squares mean
    Statistical analysis description
    LSM ratio for glucagon:dasiglucagon
    Comparison groups
    Dasiglucagon v GlucaGen
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.144
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.801
         upper limit
    		 1.033

    Secondary: Pharmacokinetics - Area under the plasma concentration curve 0-120 minutes

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    End point title
    		 Pharmacokinetics - Area under the plasma concentration curve 0-120 minutes [4]
    End point description
    The area under the concentration-time curve from zero up to the concentration at 120 minutes. To calculate AUC the standard trapezoidal method was used, based on actual rather than nominal time points.
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    Notes
    [4] - 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: No results are presented for the placebo group, as no drug was given in this group.
    End point values
    		 Dasiglucagon GlucaGen
    Number of subjects analysed
    82
    43
    Units: pmol.h/L
        arithmetic mean (standard deviation)
    1860 ± 580
    1550 ± 422
    Statistical analysis title
    		 Least squares mean
    Statistical analysis description
    LSM ratio for glucagon:dasiglucagon
    Comparison groups
    Dasiglucagon v GlucaGen
    Number of subjects included in analysis
    125
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean
    Point estimate
    0.844
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.749
         upper limit
    		 0.951

    Secondary: Pharmacokinetics - Maximum concentration

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    End point title
    		 Pharmacokinetics - Maximum concentration [5]
    End point description
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    Notes
    [5] - 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: No results are presented for the placebo group, as no drug was given in this group.
    End point values
    		 Dasiglucagon GlucaGen
    Number of subjects analysed
    82
    43
    Units: pmol/L
        arithmetic mean (standard deviation)
    1380 ± 519
    1570 ± 542
    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 [6]
    End point description
    The actual sampling time recorded for the maximum concentration.
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    Notes
    [6] - 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: No results are presented for the placebo group, as no drug was given in this group.
    End point values
    		 Dasiglucagon GlucaGen
    Number of subjects analysed
    82
    43
    Units: hour
        arithmetic mean (standard deviation)
    0.669 ± 0.158
    0.312 ± 0.117
    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
    19.1
    Reporting groups
    Reporting group title
    Dasiglucagon
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    GlucaGen
    Reporting group description
    		 -

    Serious adverse events
    		 Dasiglucagon Placebo GlucaGen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dasiglucagon Placebo GlucaGen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 82 (80.49%)
    14 / 43 (32.56%)
    32 / 43 (74.42%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 82 (12.20%)
    2 / 43 (4.65%)
    5 / 43 (11.63%)
         occurrences all number
    10
    2
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    45 / 82 (54.88%)
    1 / 43 (2.33%)
    23 / 43 (53.49%)
         occurrences all number
    46
    1
    24
    Vomiting
         subjects affected / exposed
    19 / 82 (23.17%)
    1 / 43 (2.33%)
    9 / 43 (20.93%)
         occurrences all number
    25
    1
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 82 (6.10%)
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences all number
    5
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    23 / 82 (28.05%)
    5 / 43 (11.63%)
    9 / 43 (20.93%)
         occurrences all number
    39
    6
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2018
    The following key changes and clarifications to the protocol were made:  - Coagulation was removed as a laboratory safety endpoint.  - The need for using additional contraception for patients using systemic contraceptives was removed for the inclusion criteria.  - Local German requirements were added: o Insulin glulisine (Apidra®) was defined as an investigational product. o The Investigator was to address the causality to dasiglucagon/placebo/GlucaGen® and to insulin glulisine®, respectively. o The AE summary for AEs related to insulin glulisine (Apidra®) was to be presented as an appendix to the clinical trial report.  - C-peptide and coagulation were added as parameters collected from samples at the Screening visit.  - Alterations were made for determining sample size.  - Clarification was added for patient withdrawals and missing data.

    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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