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    Clinical Trial Results:
    Evaluation of the Effect of Glucagon Solutions on the Glucose Concentration at the Subcutaneous Administration Site in Type 1 Diabetic Patients.

    Summary
    EudraCT number
    		 2014-002341-22
    Trial protocol
    		 AT  
    Global end of trial date
    13 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2024
    First version publication date
    06 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLINOX-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, A-8036
    Public contact
    Center for Medical Research (ZMF), Dept. of Internal Medicine; Division of Endocrinology and Diabetology, +43 31638572831, werner.regittnig@medunigraz.at
    Scientific contact
    Center for Medical Research (ZMF), Dept. of Internal Medicine; Division of Endocrinology and Diabetology, +43 31638572831, werner.regittnig@medunigraz.at
    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
    13 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to ascertain in humans whether commercially available glucagon solutions affect the glucose concentration in the interstitial fluid (ISF) at the subcutaneous infusion site.
    Protection of trial subjects
    Number of intravenous and subcutaneous catheters inserted as well as the number of blood samples drawn during the study visit were minimised to minimise distress and pain.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2014
    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: 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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the diabetes out-patient clinics of the Medical University of Graz. Recruitment period lasted from July 2014 to September 2014.

    Pre-assignment
    Screening details
    		 11 subjects were screened. They were male, age group of 18–65 years and diagnosed with T1D. They had to have HbA1C of <10%, body mass index between 20 and 30 kg/m2 and had to be treated with multiple daily injections or continuous subcutaneous insulin Infusion (insulin pump therapy). 1 subject has withdrawn consent before study enrollment.

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

    Arms
    Arm title
    		 Glucagon Infusion Period
    Arm description
    		 Subjects wore four microperfusion (MP) catheters over a period of 13 hours. Two of the MP catheters were perfused with glucagon solutions from Novo Nordisk (1 mg/ml, GlucaGen) and Eli Lilly (1 mg/ml, Eli Lilly Glucagon) to allow glucagon delivery and simultaneous interstitial fluid (ISF) sampling over a period of 6 hours. For comparison purposes, the two MP catheters were perfused with an isotonic solution (5%-mannitol) before the glucagon delivery period (basal period lasting 4.5 hours) and after the glucagon delivery period (lasting 2 hours).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GlucaGen and Eli Lilly Glucagon
    Investigational medicinal product code
    SUB02349MIG and SUB02347MIG
    Other name
    Glucagons from NovoNordisk and Eli Lilly
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The total amount of glucagon delivered via the two MP catheters over the 6-hour perfusion period was 0.44 mg.

    Number of subjects in period 1
    		Glucagon Infusion Period
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 The reporting group data set includes the ratio between the ISF and plasma glucose concentration observed during the glucagon infusion periods.

    Reporting group values
    		 Overall Study (overall period) 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)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.2 ( 11.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 10 10
    Subject analysis sets

    Subject analysis set title
    Basal Period
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subject analysis data set includes the ratio between the ISF and plasma glucose concentration observed during the basal periods.

    Subject analysis sets values
    		 Basal Period
    Number of subjects
    10
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    10
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    10

    End points

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    End points reporting groups
    Reporting group title
    Glucagon Infusion Period
    Reporting group description
    		 Subjects wore four microperfusion (MP) catheters over a period of 13 hours. Two of the MP catheters were perfused with glucagon solutions from Novo Nordisk (1 mg/ml, GlucaGen) and Eli Lilly (1 mg/ml, Eli Lilly Glucagon) to allow glucagon delivery and simultaneous interstitial fluid (ISF) sampling over a period of 6 hours. For comparison purposes, the two MP catheters were perfused with an isotonic solution (5%-mannitol) before the glucagon delivery period (basal period lasting 4.5 hours) and after the glucagon delivery period (lasting 2 hours).

    Subject analysis set title
    Basal Period
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The subject analysis data set includes the ratio between the ISF and plasma glucose concentration observed during the basal periods.

    Primary: ISF-To-Plasma Glucose Concentration Ratio During GlucaGen Infusion Period

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    End point title
    		 ISF-To-Plasma Glucose Concentration Ratio During GlucaGen Infusion Period
    End point description
    End point type
    Primary
    End point timeframe
    Ratio between the ISF and plasma glucose concentration observed during the basal period and the Glucagen infusion period.
    End point values
    		 Glucagon Infusion Period Basal Period
    Number of subjects analysed
    10
    10
    Units: %
        arithmetic mean (standard error)
    83.79 ( 1.97 )
    71.61 ( 3.23 )
    Statistical analysis title
    		 ISF-To-Plasma Ratio - GlucaGen Infusion vs Basal
    Comparison groups
    Glucagon Infusion Period v Basal Period
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Glucagon Infusion Period vs Basal Period

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    End point title
    		 Glucagon Infusion Period vs Basal Period
    End point description
    End point type
    Secondary
    End point timeframe
    Ratio between the ISF and plasma glucose concentration observed during the basal period and the Eli Lilly Glucagon infusion period.
    End point values
    		 Glucagon Infusion Period Basal Period
    Number of subjects analysed
    10
    10
    Units: %
        arithmetic mean (standard error)
    89.22 ( 2.39 )
    68.45 ( 4.11 )
    Statistical analysis title
    		 ISF-To-Plasma Ratio - Eli Lilly Infusion vs Basal
    Comparison groups
    Glucagon Infusion Period v Basal Period
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were assessed during the whole study duration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events occured during this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2014
    Inclusion of the use of an alternative tissue catheter type.

    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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