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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Assessment of Hepatic Glucose Production Following Repeated Glucagon Administration in Type 1 Diabetes Patients

    Summary
    EudraCT number
    		 2013-001407-36
    Trial protocol
    		 AT  
    Global end of trial date
    10 Apr 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HEPPI
    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), Medical University of Graz; Dept. of Internal Medicine; Division of Endocrinology and Diabetology, +43 31638572831, werner.regittnig@medunigraz.at
    Scientific contact
    Center for Medical Research (ZMF), Medical University of Graz; 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
    31 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the effect of repeated subcutaneous glucagon administration on the hepatic glucose production in type 1 diabetic patients under fed and fasted conditions.
    Protection of trial subjects
    Number of intravenous catheters inserted as well as the number of blood samples drawn during the two study visits were minimised to minimise distress and pain.
    Background therapy
    		 On the days before and after the two study visits, study subjects were either treated with multiple daily injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2013
    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: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited from the diabetes out-patient clinic of the Medical University of Graz. Recruitment period lasted from May 2013 to April 2014.

    Pre-assignment
    Screening details
    		 10 subjects were screened. They were of both sexes, in the age group of 18–64 years and diagnosed with type 1 diabetes. They had to have HbA1C values of <10%, and had to be treated with multiple daily injection of insulin or continuous subcutaneous insulin infusion. One patient was excluded due to a screening failure.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Fasted Conditions
    Arm description
    		 In this arm, subjects were given three subcutaneous boluses of glucagon (1 mg) in the fasted state (i.e., 20 hours post-meal). The boluses of glucagon were separated by 180 minutes. To restore normoglycemia after each glucagon bolus, the subjects engaged in moderate-intensity exercise.
    Arm type
    		 crossover

    Investigational medicinal product name
    Glucagon
    Investigational medicinal product code
    SUB02347MIG
    Other name
    GlucaGen
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 x 1 mg

    Arm title
    		 Fed Conditions
    Arm description
    		 In this arm, subjects were given three subcutaneous boluses of glucagon (1 mg) in the fed state (i.e., 6 hours post-meal). The boluses of glucagon were separated by 180 minutes. To restore normoglycemia after each glucagon bolus, the subjects engaged in moderate-intensity exercise.
    Arm type
    		 crossover

    Investigational medicinal product name
    Glucagon
    Investigational medicinal product code
    SUB02347MIG
    Other name
    GlucaGen
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 x 1 mg

    Number of subjects in period 1
    		Fasted Conditions Fed Conditions
    Started
    7
    6
    Completed
    4
    4
    Not completed
    3
    2
         Adverse event, non-fatal
    2
    1
         Protocol deviation
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 Overall Population as this is a cross-over trial

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 9 9
    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
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.7 ± 7.8 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 6 6

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Fasted Conditions
    Reporting group description
    		 In this arm, subjects were given three subcutaneous boluses of glucagon (1 mg) in the fasted state (i.e., 20 hours post-meal). The boluses of glucagon were separated by 180 minutes. To restore normoglycemia after each glucagon bolus, the subjects engaged in moderate-intensity exercise.

    Reporting group title
    Fed Conditions
    Reporting group description
    		 In this arm, subjects were given three subcutaneous boluses of glucagon (1 mg) in the fed state (i.e., 6 hours post-meal). The boluses of glucagon were separated by 180 minutes. To restore normoglycemia after each glucagon bolus, the subjects engaged in moderate-intensity exercise.

    Primary: AUC HGP - fasted vs. fed conditions

    		 Close Top of page
    End point title
    		 AUC HGP - fasted vs. fed conditions
    End point description
    End point type
    Primary
    End point timeframe
    Area under the hepatic glucose production curve (AUC HGP) from 0 to 90 minutes after the glucagon bolus injections.
    End point values
    		 Fasted Conditions Fed Conditions
    Number of subjects analysed
    4
    4
    Units: mg/kg
        arithmetic mean (standard error)
    1224.9 ± 118.2
    1268.4 ± 79.0
    Statistical analysis title
    		 AUC HGP - fasted vs. fed conditions
    Comparison groups
    Fasted Conditions v Fed Conditions
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.82
    Method
    		 2-sided paired t-test
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    from the onset of screening to the last patient last visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Loss of consciousness
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 9 (66.67%)
         occurrences all number
    9
    Vomiting
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4

    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-Mon Apr 29 00:54:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA