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    Clinical Trial Results:
    Dasiglucagon in the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass

    Summary
    EudraCT number
    		 2019-001915-22
    Trial protocol
    		 DK  
    Global end of trial date
    26 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2021
    First version publication date
    31 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CKN-DASI-RYGB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03984370
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Center for Clinical Metabolic Research at Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 7, hall 7, 3rd floor, Hellerup, Denmark, 2900
    Public contact
    Herlev-Gentofte Hospital, Center for Clinical Metabolic Research at Herlev-Gentofte Hospital, +45 60117434, casper.kjaersgaard.nielsen@regionh.dk
    Scientific contact
    Herlev-Gentofte Hospital, Center for Clinical Metabolic Research at Herlev-Gentofte Hospital, +45 60117434, casper.kjaersgaard.nielsen@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
    26 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This wasa proof-of-concept study aiming to evaluate the use of dasiglucagon in the management of postprandial hyperinsulinaemic hypoglycaemia in RYGB-operated individuals. To examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from postprandial hyperinsulinaemic hypoglycaemia by use of a mixed meal test (MMT). The study was designed as a double-blinded, randomised, placebo-controlled, 3-period, 3-treatment, crossover study comprising 3 separate treatment days (MMTs).
    Protection of trial subjects
    Participants are offered a healthy lunch followed by a 30-minute observation period after completion of each MMTs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2019
    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
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 - Oral and written information about the study. - Oral and written informed consent. - Review of inclusion and exclusion criteria. - Measurement of blood pressure, pulse, weight and height. - Fasting blood samples analysis including for, anaemia: basofilocytes, eosinofilocytes, erythrocytes, ferritin, haemoglobin, folate, iron, leukocytes, lymp

    Pre-assignment
    Screening details
    		 A physician evaluated if inclusion criteria were fulfilled before enrollment

    Period 1
    Period 1 title
    Overall (placebo, 80 and 200 ug dasiglu) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Blinding procedure was successful

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,4 mL of placebo

    Arm title
    		 80 ug dasiglucagon
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasiglucagon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    80 ug dasiglucagon s.c. in abdomen

    Arm title
    		 200 ug dasiglucagon
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasiglucagon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 ug dasiglucagon s.c. in abdomen

    Number of subjects in period 1
    		Placebo 80 ug dasiglucagon 200 ug dasiglucagon
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall (placebo, 80 and 200 ug dasiglu)
    Reporting group description
    		 10 subjects at the baseline

    Reporting group values
    		 Overall (placebo, 80 and 200 ug dasiglu) Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 2 2

    End points

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

    Reporting group title
    80 ug dasiglucagon
    Reporting group description
    		 -

    Reporting group title
    200 ug dasiglucagon
    Reporting group description
    		 -

    Primary: Nadir plasma glucose concentration

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    End point title
    		 Nadir plasma glucose concentration
    End point description
    End point type
    Primary
    End point timeframe
    Nadir plasma glucose concentration within 240 minutes after MMT.
    End point values
    		 Placebo 80 ug dasiglucagon 200 ug dasiglucagon
    Number of subjects analysed
    10 [1]
    10 [2]
    10 [3]
    Units: mmol/l
        arithmetic mean (standard error)
    3.0 ± 0.2
    3.9 ± 0.3
    4.5 ± 0.3
    Attachments
    		 Nadir glucose concentration
    Notes
    [1] - placebo
    [2] - 80 ug
    [3] - 200 ug
    Statistical analysis title
    		 Pla vs. 200 ug
    Statistical analysis description
    A mixed model with Sidak corrections for multiple comparisons
    Comparison groups
    Placebo v 200 ug dasiglucagon
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 2.05
    Statistical analysis title
    		 Pla vs. 80 ug
    Statistical analysis description
    A mixed model with Sidak corrections for multiple comparisons
    Comparison groups
    Placebo v 80 ug dasiglucagon
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.01 [4]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.35
    Notes
    [4] - Sidak corrected

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-240 during the MMts
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    All adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 All adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Sweatiness
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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