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    Clinical Trial Results:
    Effect of the GLP-1 receptor agonist exenatide on impaired hypoglycaemic awareness in type 1 diabetes

    Summary
    EudraCT number
    		 2016-000790-21
    Trial protocol
    		 NL  
    Global end of trial date
    03 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions
    Summary report(s)
    		 Paper effect of GLP-1 receptor agonist on IAH

    Trial information

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    Trial identification
    Sponsor protocol code
    ESR-15-10862
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02735031
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    PO Box 9101, Nijmegen, Netherlands,
    Public contact
    Lian van Meijel, Radboudumc, 31 243613286, Lian.vanMeijel@radboudumc.nl
    Scientific contact
    Lian van Meijel, Radboudumc, 31 243613286, Lian.vanMeijel@radboudumc.nl
    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
    03 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of treatment with the GLP-1ra exenatide on the awareness of and counterregulatory hormone responses to hypoglycaemia in people with type 1 diabetes and impaired hypoglycaemic awareness
    Protection of trial subjects
    All the data collected for this study was coded by a unique identification code.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2016
    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
    Netherlands: 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
    		 Participants were recruited between January 2017 and November 2017, with a follow-up period between February 2017 and March 2018

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Type 1 diabetes, disease duration ≥ 1 year - Age: 18-70 years - Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) - Body-Mass Index: 19-40 kg/m2 - Glycated hemoglobin (HbA1c)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Exenatide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    5 microgram twice daily

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    5 microgram twice daily

    Number of subjects in period 1
    		Exenatide Placebo
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial 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
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 4 4

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Symptom score in response to hypoglycemia

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    End point title
    		 Symptom score in response to hypoglycemia
    End point description
    End point type
    Primary
    End point timeframe
    Five timepoints during hypoglycemic clamps (baseline, after 30 min of euglycemia, twice during hypoglycemia (after 20 and 40 min) and 45 minutes after recovery from hypoglycemia)
    End point values
    		 Exenatide Placebo
    Number of subjects analysed
    10
    10
    Units: points
    10
    10
    Statistical analysis title
    		 Paired samples t-test
    Comparison groups
    Exenatide v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    January 2017 and March 2018
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences all number
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2017
    Change of inclusion criterion, from 18-70 years to 18-75 years old

    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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