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    Clinical Trial Results:
    A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

    Summary
    EudraCT number
    		 2017-004545-24
    Trial protocol
    		 DE   GB  
    Global end of trial date
    07 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2022
    First version publication date
    11 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZP4207-17103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04172441
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand Pharma A/S
    Sponsor organisation address
    Sydmarken 11, Soeborg, Denmark, 2860
    Public contact
    Clinical Operations, Zealand Pharma A/S, 45 88 77 36 00, clinicaltrials@zealandpharma.com
    Scientific contact
    Clinical Operations, Zealand Pharma A/S, 45 88 77 36 00, clinicaltrials@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
    18 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent CHI requiring continuous IV glucose administration to prevent/manage 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
    19 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Germany: 1
    Worldwide total number of subjects
    13
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    3
    Infants and toddlers (28 days-23 months)
    10
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was conducted at a total of 4 sites; in the USA (2 sites), UK (1 site) and Germany (1 site).

    Pre-assignment
    Screening details
    		 A total of 16 patients were screened of which 13 patients were randomized. However, 1 patient was randomized in error and not treated.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Dasiglucagon
    Arm description
    		 Subjects in this arm received dasiglucagon continuous infusion via an infusion pump. Patients were randomly assigned in a double-blind fashion to receive dasiglucagon or placebo for 48 hours, after which they were crossed over to the other trial treatment for an additional 48 hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dasiglucagon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dasiglucagon was administered via a subcutaneous infusion pump. The dose was titrated in a manner linked to the plasma glucose level achieved, and thus the dose varied between patients.

    Arm title
    		 Placebo
    Arm description
    		 Subjects in this arm received placebo. Patients were randomly assigned in a double-blind fashion to receive dasiglucagon or placebo for 48 hours, after which they were crossed over to the other trial treatment for an additional 48 hours.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The placebo dose was titrated in a manner linked to the plasma glucose level achieved, and thus the dose varied between patients.

    Number of subjects in period 1
    		Dasiglucagon Placebo
    Started
    12
    12
    Completed
    12
    12
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Dasiglucagon
    Arm description
    		 Subjects received open-label treatment with dasiglucagon for 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dasiglucagon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dasiglucagon was administered via a subcutaneous infusion pump. The dose was titrated in a manner linked to the plasma glucose level achieved, and thus the dose varied between patients.

    Number of subjects in period 2
    		Dasiglucagon
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Part 1 of the trial utilised a cross-over design. A total of 12 subject received both dasiglucagon and placebo in Part 1 of the trial.
    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 3 3
        Infants and toddlers (28 days-23 months)
    		 9 9
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 71.25 ( 84.976 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Dasiglucagon
    Reporting group description
    		 Subjects in this arm received dasiglucagon continuous infusion via an infusion pump. Patients were randomly assigned in a double-blind fashion to receive dasiglucagon or placebo for 48 hours, after which they were crossed over to the other trial treatment for an additional 48 hours.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this arm received placebo. Patients were randomly assigned in a double-blind fashion to receive dasiglucagon or placebo for 48 hours, after which they were crossed over to the other trial treatment for an additional 48 hours.
    Reporting group title
    Dasiglucagon
    Reporting group description
    		 Subjects received open-label treatment with dasiglucagon for 21 days.

    Primary: Mean IV GIR in the last 12 hours of each treatment period during Part 1

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    End point title
    		 Mean IV GIR in the last 12 hours of each treatment period during Part 1
    End point description
    Mean Intravenous Glucose Infusion Rate in the last 12 hours of each treatment period during Part 1 (dasiglucagon or placebo administration).
    End point type
    Primary
    End point timeframe
    Measured over the last 12-hour treatment period at the end of each of the cross-over treatment periods in Part 1, from 36h to 48 h and from 84h to 96h after the start of study treatment.
    End point values
    		 Dasiglucagon Placebo
    Number of subjects analysed
    12
    12
    Units: mg/kg/min
        arithmetic mean (standard deviation)
    4.33 ( 4.922 )
    9.51 ( 5.655 )
    Statistical analysis title
    		 Primary Statistical Analysis
    Statistical analysis description
    The primary analysis was defined by the estimand based on the treatment policy (de-facto) strategy, where the actual GIR measurement reported irrespective of adherence to treatment or the use of subsequent therapy were used for the analysis . The difference in weighted mean IV GIR between placebo and dasiglucagon was estimated.
    Comparison groups
    Dasiglucagon v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0037
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.29
         upper limit
    		 -2.13
    Notes
    [1] - Mixed model with treatment and period as fixed effects and patient as random effect.

    Secondary: Total amount of carbohydrates administered per day during Part 1

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    End point title
    		 Total amount of carbohydrates administered per day during Part 1
    End point description
    Total amount (g) of carbohydrates administered (regardless of the route) per day during each of the 48-hour treatment periods in Part 1.
    End point type
    Secondary
    End point timeframe
    Day 1 to 4, summarised for each 48-hour treatment period
    End point values
    		 Dasiglucagon Placebo
    Number of subjects analysed
    12
    12
    Units: gram(s)
        arithmetic mean (standard deviation)
    106.7 ( 53.72 )
    139.1 ( 57.35 )
    No statistical analyses for this end point

    Secondary: Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1

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    End point title
    		 Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1
    End point description
    The weighted mean intravenous (IV) Glucose Infusion Rate (GIR) <10 mg/kg/min over the last 12-hour treatment period of Part 1.
    End point type
    Secondary
    End point timeframe
    Over the last 12-hour treatment period in the last treatment period of Part 1.
    End point values
    		 Dasiglucagon Placebo
    Number of subjects analysed
    12
    12
    Units: Subjects
        Less than 10 mg/kg/min
    9
    6
        Greater than or equal to 10 mg/kg/min
    3
    6
    No statistical analyses for this end point

    Secondary: Time to complete weaning off IV GIR

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    End point title
    		 Time to complete weaning off IV GIR
    End point description
    Time to complete weaning off IV GIR (time from first exposure during Part 2 to stop of IV glucose infusion). Complete weaning off IV GIR was defined as the first point in time when the patient had been off IV GIR for 12 hours.
    End point type
    Secondary
    End point timeframe
    From day 5-25.
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Subjects
        End of Week 1
    7
        End of Week 2
    10
        End of Week 3
    10
    No statistical analyses for this end point

    Secondary: Hypoglycaemia event rate as detected by SMPG

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    End point title
    		 Hypoglycaemia event rate as detected by SMPG
    End point description
    Hypoglycaemia event rate, defined as number of hypoglycaemic events (PG <70 mg/dL or 3.9 mmol/L), as detected by SMPG
    End point type
    Secondary
    End point timeframe
    Day 5 to 25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Hypoglycaemic events
        arithmetic mean (standard deviation)
    9.47 ( 9.121 )
    No statistical analyses for this end point

    Secondary: Clinically significant hypoglyceamia event rate as detected by SMPG

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    End point title
    		 Clinically significant hypoglyceamia event rate as detected by SMPG
    End point description
    Clinically significant hypoglycaemia event rate, defined as number of events <54 mg/dL (3.0 mmol/L), as detected by SMPG
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Hypoglycaemic events
        arithmetic mean (standard deviation)
    2.70 ( 3.641 )
    No statistical analyses for this end point

    Secondary: Time to actual hospital discharge

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    End point title
    		 Time to actual hospital discharge
    End point description
    Time to actual hospital discharge, defined as the time from first exposure during Part 2 to discharge from hospital, presented as cumulative number of subjects with discharge per week.
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Subjects
        End of Week 1
    0
        End of Week 2
    4
        End of Week 3
    4
    No statistical analyses for this end point

    Secondary: Time to pancreatic surgery (sub-total or total pancreatectomy)

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    End point title
    		 Time to pancreatic surgery (sub-total or total pancreatectomy)
    End point description
    Time to pancreatic surgery (sub-total or total pancreatectomy), presented by cumulative number of subjects receiving sub-total or total pancreatectomy (with a cutoff of ≥95%) by week.
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Subjects
        End of Week 1
    0
        End of Week 2
    1
        End of Week 3
    1
        End of Week 4
    1
    No statistical analyses for this end point

    Secondary: Amount of Carbohydrates Administration - Total

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    End point title
    		 Amount of Carbohydrates Administration - Total
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: gram(s) per day
    arithmetic mean (standard deviation)
        Week 1
    104.41 ( 38.927 )
        Week 2
    92.43 ( 50.278 )
        Week 3
    92.81 ( 58.265 )
        Weeks 1-3
    95.40 ( 40.723 )
    No statistical analyses for this end point

    Secondary: Amount of Carbohydrates Administration - IV Glucose or Total Parenteral Nutrition

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    End point title
    		 Amount of Carbohydrates Administration - IV Glucose or Total Parenteral Nutrition
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: grams (g) per day
    arithmetic mean (standard deviation)
        Week 1
    46.06 ( 33.155 )
        Week 2
    19.05 ( 29.637 )
        Week 3
    31.50 ( 51.174 )
        Weeks 1-3
    32.24 ( 27.569 )
    No statistical analyses for this end point

    Secondary: Amount of Carbohydrates Administration - Oral

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    End point title
    		 Amount of Carbohydrates Administration - Oral
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: gram(s) per day
    arithmetic mean (standard deviation)
        Week 1
    22.99 ( 24.033 )
        Week 2
    23.69 ( 33.582 )
        Week 3
    14.91 ( 21.554 )
        Weeks 1-3
    22.67 ( 25.099 )
    No statistical analyses for this end point

    Secondary: Amount of Carbohydrates Administration - NG-tube or Gastrostomy

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    End point title
    		 Amount of Carbohydrates Administration - NG-tube or Gastrostomy
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: gram(s) per day
    arithmetic mean (standard deviation)
        Week 1
    35.36 ( 28.788 )
        Week 2
    49.69 ( 26.597 )
        Week 3
    46.41 ( 26.820 )
        Weeks 1-3
    40.49 ( 25.836 )
    No statistical analyses for this end point

    Secondary: CGM percent time in range 70-180 mg/dL (3.9-10.0 mmol/L)

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    End point title
    		 CGM percent time in range 70-180 mg/dL (3.9-10.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: percent
    median (full range (min-max))
        Week 1
    88.88 (34.5 to 94.3)
        Week 2
    88.24 (51.0 to 95.9)
        Week 3
    91.42 (36.3 to 100.0)
        Weeks 1-3
    88.35 (42.5 to 100.00)
    No statistical analyses for this end point

    Secondary: CGM percent time in hypoglycemia (<70 mg/dL or 3.9 mmol/L)

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    End point title
    		 CGM percent time in hypoglycemia (<70 mg/dL or 3.9 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: percent
    median (full range (min-max))
        Week 1
    7.05 (1.0 to 24.5)
        Week 2
    7.35 (0.6 to 49.0)
        Week 3
    5.73 (0.0 to 22.1)
        Weeks 1-3
    6.67 (0.0 to 30.0)
    No statistical analyses for this end point

    Secondary: CGM percent time in clinically significant hypoglycaemia (<54 mg/dL or 3.0 mmol/L)

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    End point title
    		 CGM percent time in clinically significant hypoglycaemia (<54 mg/dL or 3.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: percent
    median (full range (min-max))
        Week 1
    1.92 (0.2 to 6.0)
        Week 2
    2.03 (0.0 to 20.4)
        Week 3
    0.88 (0.0 to 6.9)
        Weeks 1-3
    1.75 (0.0 to 9.2)
    No statistical analyses for this end point

    Secondary: Rate of hypoglycaemia episodes for 15 min or more, as measured by CGM

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    End point title
    		 Rate of hypoglycaemia episodes for 15 min or more, as measured by CGM
    End point description
    Rate of hypoglycemia episodes, defined as number of episodes <70 mg/dL (3.9 mmol/L) for 15 min or more, as measured by CGM
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Hypoglycaemic events
    median (full range (min-max))
        Week 1
    22.00 (3.0 to 58.0)
        Week 2
    26.00 (3.0 to 74.7)
        Week 3
    18.63 (0.0 to 57.2)
        Weeks 1-3
    18.54 (0.0 to 66.3)
    No statistical analyses for this end point

    Secondary: Rate of clinically significant hypoglycemia episodes for 15 min or more, as measured by CGM.

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    End point title
    		 Rate of clinically significant hypoglycemia episodes for 15 min or more, as measured by CGM.
    End point description
    Rate of clinically significant hypoglycemia episodes, defined as number of episodes <54 mg/dL (3.0 mmol/L) for 15 min or more, as measured by CGM
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: Hypoglycaemic episodes
    median (full range (min-max))
        Week 1
    5.00 (1.0 to 23.0)
        Week 2
    8.00 (0.0 to 46.7)
        Week 3
    2.67 (0.0 to 18.7)
        Weeks 1-3
    5.00 (0.0 to 34.8)
    No statistical analyses for this end point

    Secondary: Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by CGM

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    End point title
    		 Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by CGM
    End point description
    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by CGM
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: mmol/L
    median (full range (min-max))
        Week 1
    0.04 (0.0 to 0.2)
        Week 2
    0.05 (0.0 to 0.05)
        Week 3
    0.03 (0.0 to 0.2)
        Weeks 1-3
    0.05 (0.0 to 0.2)
    No statistical analyses for this end point

    Secondary: Extent of clinically significant hypoglycaemia (AOCglucose below 54 mg/dL [3.0 mmol/L]) as measured by CGM

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    End point title
    		 Extent of clinically significant hypoglycaemia (AOCglucose below 54 mg/dL [3.0 mmol/L]) as measured by CGM
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: mmol/L
    median (full range (min-max))
        Week 1
    0.01 (0.0 to 0.01)
        Week 2
    0.02 (0.0 to 0.1)
        Week 3
    0.01 (0.0 to 0.01)
        Weeks 1-3
    0.01 (0.0 to 0.01)
    No statistical analyses for this end point

    Secondary: CGM percent time in hyperglycaemia (>180 mg/dL or 10.0 mmol/L)

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    End point title
    		 CGM percent time in hyperglycaemia (>180 mg/dL or 10.0 mmol/L)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5-25
    End point values
    		 Dasiglucagon
    Number of subjects analysed
    12
    Units: percent
    median (full range (min-max))
        Week 1
    1.44 (0.0 to 64.5)
        Week 2
    0.15 (0.0 to 45.0)
        Week 3
    0.32 (0.0 to 62.7)
        Weeks 1-3
    0.78 (0.0 to 56.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Dasiglucagon - Part 1
    Reporting group description
    		 Subjects in this arm received dasiglucagon continuous infusion via an infusion pump.

    Reporting group title
    Placebo - Part 1
    Reporting group description
    		 Subjects in this arm received placebo.

    Reporting group title
    Dasiglucagon - Part 2
    Reporting group description
    		 AEs occurring in Part 2 of the trial.

    Serious adverse events
    		 Dasiglucagon - Part 1 Placebo - Part 1 Dasiglucagon - Part 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dasiglucagon - Part 1 Placebo - Part 1 Dasiglucagon - Part 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    7 / 12 (58.33%)
    10 / 12 (83.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Thrombophlebitis Superficial
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    2
    Face oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Medical device site reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Tachypnoea
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1
    Pulmonary oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    1
    1
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    4
    Normocytic anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    1
    1
    2
    Constipation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Rash papular
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    3
    Dermatitis diaper
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    2
    Acne infantile
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Sensitive skin
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Finger deformity
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Device related sepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Eye infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    3
    Hyponatraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    4
    Acidosis hyperchloraemic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Fluid retention
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Hypochloraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2020
    Dexcom G4 was changed to Dexcom G6 as the G4 was being phased out. Statistical section was updated focusing on the key secondary analysis description; the endpoint was rewritten to match the description in the endpoint section Pharmacokinetics/drug exposure section was updated: Visit 5 corrected to Day 5
    04 Jun 2021
    Updates to the secondary endpoints. Statistical section was updated with the updated endpoints. The safety section was clarified further.

    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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