Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People with Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study

    Summary
    EudraCT number
    		 2020-005745-16
    Trial protocol
    		 DK  
    Global end of trial date
    28 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2023
    First version publication date
    24 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    77119
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04764968
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Regional Scientific Ethics Committee: H-21000002
    Sponsors
    Sponsor organisation name
    Steno Diabetes Center Copenhagen
    Sponsor organisation address
    Borgmester Ib Juuls Vej 83, Herlev, Denmark, 2730
    Public contact
    Christian Laugesen, Steno Diabetes Center Copenhagen, +45 51642387, christian.laugesen@regionh.dk
    Scientific contact
    Christian Laugesen, Steno Diabetes Center Copenhagen, +45 51642387, christian.laugesen@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
    Final
    Date of interim/final analysis
    14 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose (80 μg) dasiglucagon administered via an investigational trial device (a multi-dose reusable pen injector) in preventing and treating mild hypoglycemia in insulin pump-treated people type 1 diabetes
    Protection of trial subjects
    N/A
    Background therapy
    		 All participants used their regular treatment modality (insulin pump therapy including stand-alone CGM).
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    27 Apr 2021
    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
    Denmark: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    20
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited from the outpatient diabetes clinic at Steno Diabetes Center Copenhagen from May 2021 to November 2021.

    Pre-assignment
    Screening details
    		 After providing oral and written informed consent, participants completed a screening visit for assessment of the eligibility criteria. Procedures included routine blood sampling, physical examination, review of medical history and medications as well as registration of baseline characteristics.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Dasiglucagon period
    Arm description
    		 2-week period where participants managed impending and manifested episodes of hypoglycaemia with pen-administered low-dose (80 μg) s.c. dasiglucagon using a multi-dose reusable pen injector.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dasiglucagon
    Investigational medicinal product code
    Other name
    CAS15 number: 1544300-84-6, EV Substance code: SUB193123
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administration of s.c. dasiglucagon (80 ug) using a multi-dose reusable pen injector.

    Arm title
    		 Usual care period
    Arm description
    		 2-week period where participants managed impending and manifested episodes of hypoglycaemia with usual care (i.e. consumption of carbohydrates)
    Arm type
    		 Usual care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Dasiglucagon period Usual care period
    Started
    24
    24
    Completed
    24
    24

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Study period
    Reporting group description
    		 All 24 participants included in the study

    Reporting group values
    		 Study period Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ± 15 -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 10 10
    Duration of diabetes
    Units: Years
        arithmetic mean (standard deviation)
    		 27 ± 13 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 84.2 ± 14.2 -
    Body mass index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 28.3 ± 4.2 -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 130 ± 15 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 82 ± 7 -
    Hemoglobin A1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 56 ± 6 -
    Hemoglobin A1c
    Units: Percentage
        arithmetic mean (standard deviation)
    		 7.3 ± 0.5 -
    Duration of insulin pump use
    Units: Years
        arithmetic mean (standard deviation)
    		 8 ± 1 -
    Total daily insulin dose
    Units: Units
        arithmetic mean (standard deviation)
    		 45 ± 20 -
    Daily basal insulin dose
    Units: Units
        arithmetic mean (standard deviation)
    		 21 ± 10 -
    Daily bolus insulin dose
    Units: Units
        arithmetic mean (standard deviation)
    		 24 ± 11 -
    Subject analysis sets

    Subject analysis set title
    Dasiglucagon period
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2-week period where participants managed impending and manifested episodes of hypoglycaemia with pen-administered low-dose (80 μg) s.c. dasiglucagon using a multi-dose reusable pen injector.

    Subject analysis set title
    Usual care period
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2-week period where participants managed impending and manifested episodes of hypoglycaemia with usual care (i.e. consumption of carbohydrates)

    Subject analysis sets values
    		 Dasiglucagon period Usual care period
    Number of subjects
    24
    24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    Duration of diabetes
    Units: Years
        arithmetic mean (standard deviation)
    ±
    ±
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    84.2 ± 14.2
    84.2 ± 14.2
    Body mass index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    28.3 ± 4.2
    28.3 ± 4.2
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    ±
    ±
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    ±
    ±
    Hemoglobin A1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    ±
    ±
    Hemoglobin A1c
    Units: Percentage
        arithmetic mean (standard deviation)
    7.3 ± 0.5
    7.3 ± 0.5
    Duration of insulin pump use
    Units: Years
        arithmetic mean (standard deviation)
    ±
    ±
    Total daily insulin dose
    Units: Units
        arithmetic mean (standard deviation)
    ±
    ±
    Daily basal insulin dose
    Units: Units
        arithmetic mean (standard deviation)
    ±
    ±
    Daily bolus insulin dose
    Units: Units
        arithmetic mean (standard deviation)
    ±
    ±

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Dasiglucagon period
    Reporting group description
    		 2-week period where participants managed impending and manifested episodes of hypoglycaemia with pen-administered low-dose (80 μg) s.c. dasiglucagon using a multi-dose reusable pen injector.

    Reporting group title
    Usual care period
    Reporting group description
    		 2-week period where participants managed impending and manifested episodes of hypoglycaemia with usual care (i.e. consumption of carbohydrates)

    Subject analysis set title
    Dasiglucagon period
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2-week period where participants managed impending and manifested episodes of hypoglycaemia with pen-administered low-dose (80 μg) s.c. dasiglucagon using a multi-dose reusable pen injector.

    Subject analysis set title
    Usual care period
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    2-week period where participants managed impending and manifested episodes of hypoglycaemia with usual care (i.e. consumption of carbohydrates)

    Primary: Percentage of time in range (3.9-10 mmol/L)

    		 Close Top of page
    End point title
    		 Percentage of time in range (3.9-10 mmol/L)
    End point description
    End point type
    Primary
    End point timeframe
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        arithmetic mean (standard deviation)
    63.5 ± 11
    61.1 ± 15
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1286
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 5.5

    Secondary: Percentage of time below range (<3.9 mmol/L)

    		 Close Top of page
    End point title
    		 Percentage of time below range (<3.9 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    2-week usual care period and 2-week dasiglucagon period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        arithmetic mean (standard deviation)
    2.5 ± 3
    3.1 ± 4
    Statistical analysis title
    		 Difference between intervenstions
    Statistical analysis description
    The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1622
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 0.2

    Secondary: Percentage of time above range (>10 mmol/L)

    		 Close Top of page
    End point title
    		 Percentage of time above range (>10 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    2-week usual care period and 2-week dasiglucagon period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        arithmetic mean (standard deviation)
    33.9 ± 13
    35.8 ± 17
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.2772
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 1.6
    Notes
    [1] - The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.

    Secondary: Coefficient of variation

    		 Close Top of page
    End point title
    		 Coefficient of variation
    End point description
    End point type
    Secondary
    End point timeframe
    2-week usual care period and 2-week dasiglucagon period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        arithmetic mean (standard deviation)
    35.6 ± 4
    35.2 ± 5
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.5503
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.8
    Notes
    [2] - The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.

    Secondary: Successful cases (%) of hypoglycemia treatment

    		 Close Top of page
    End point title
    		 Successful cases (%) of hypoglycemia treatment
    End point description
    Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment
    End point type
    Secondary
    End point timeframe
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        number (not applicable)
    86
    77
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The endpoint was evaluated using a logistic regression model with random subject effect using sequence, period, and event baseline sensor glucose value as a covariate.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1597
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 2.86

    Secondary: Successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia

    		 Close Top of page
    End point title
    		 Successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia
    End point description
    Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment AND sensor glucose level ≤ 10 mmol/l during the first two hours post-treatment
    End point type
    Secondary
    End point timeframe
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        number (not applicable)
    57
    57
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The endpoint was evaluated using a logistic regression model with random subject effect using sequence, period, and event baseline sensor glucose value as a covariate.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3215
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.27

    Secondary: Successful cases (%) of hypoglycemia prevention

    		 Close Top of page
    End point title
    		 Successful cases (%) of hypoglycemia prevention
    End point description
    Initial sensor glucose level > 3.9 mmol/l AND sensor glucose level < 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment
    End point type
    Secondary
    End point timeframe
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Percentage
        number (not applicable)
    90
    80
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The endpoint was evaluated using a logistic regression model with random subject effect using sequence, period, and event baseline sensor glucose value as a covariate.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0177
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 7.41

    Secondary: Time (in minutes) from hypoglycemia treatment to euglycemia

    		 Close Top of page
    End point title
    		 Time (in minutes) from hypoglycemia treatment to euglycemia
    End point description
    Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l
    End point type
    Secondary
    End point timeframe
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Minutes
        median (inter-quartile range (Q1-Q3))
    16 (12 to 23)
    21 (13 to 30)
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The endpoint was evaluated using a proportional hazards regression model with gamma-distributed random effect using sequence, period, and event baseline sensor glucose value as a covariate.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0064
    Method
    		 Regression, Cox
    Parameter type
    		 Rate ratio (RR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.87

    Secondary: Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration

    		 Close Top of page
    End point title
    		 Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration
    End point description
    End point type
    Secondary
    End point timeframe
    2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period
    Number of subjects analysed
    24
    Units: Number of episodes
    22
    No statistical analyses for this end point

    Secondary: Total daily insulin dose

    		 Close Top of page
    End point title
    		 Total daily insulin dose
    End point description
    End point type
    Secondary
    End point timeframe
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: Units
        arithmetic mean (standard deviation)
    47.1 ± 22
    46.4 ± 20
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5148
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 2.9

    Secondary: Total daily carbohydrate intake

    		 Close Top of page
    End point title
    		 Total daily carbohydrate intake
    End point description
    End point type
    Secondary
    End point timeframe
    2-week 'dasiglucagon' period
    End point values
    		 Dasiglucagon period Usual care period
    Number of subjects analysed
    24
    24
    Units: grams
        arithmetic mean (standard deviation)
    171 ± 59
    191 ± 66
    Statistical analysis title
    		 Difference between interventions
    Statistical analysis description
    The treatment effect was evaluated by comparing treatment groups using a linear mixed model that included the factors treatment (2 levels), sequence (2 levels), period (2 levels), and a random subject effect.
    Comparison groups
    Dasiglucagon period v Usual care period
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34
         upper limit
    		 -6

    Secondary: Patient-reported outcome

    		 Close Top of page
    End point title
    		 Patient-reported outcome
    End point description
    Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire ("How likely is it that you, given the option, would use dasiglucagon as part of your diabetes management?" (Answer options: Very unlikely, unlikely, likely, very likely).
    End point type
    Secondary
    End point timeframe
    At the end-of-study visit
    End point values
    		 Dasiglucagon period
    Number of subjects analysed
    24
    Units: Percentage
        number (not applicable)
    96
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    2-week 'usual care' period and 2-week 'dasiglucagon' period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Dasiglucagon period
    Reporting group description
    		 -

    Reporting group title
    Usual care period
    Reporting group description
    		 -

    Serious adverse events
    		 Dasiglucagon period Usual care period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (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: 0%
    Non-serious adverse events
    		 Dasiglucagon period Usual care period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 24 (45.83%)
    10 / 24 (41.67%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 24 (4.17%)
         occurrences all number
    4
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 24 (41.67%)
    8 / 24 (33.33%)
         occurrences all number
    36
    22
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 24 (33.33%)
    4 / 24 (16.67%)
         occurrences all number
    34
    17
    Vomiting
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Stomachache
         subjects affected / exposed
    4 / 24 (16.67%)
    3 / 24 (12.50%)
         occurrences all number
    16
    15

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 16 11:21:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA