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    Clinical Trial Results:
    Effects of continuous exercise on time spent in euglycemia and inflammation under the treatment of insulin degludec in patients with type 1 diabetes – a crossover, randomized trial (InflamEx)

    Summary
    EudraCT number
    		 2017-000922-37
    Trial protocol
    		 AT  
    Global end of trial date
    16 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2024
    First version publication date
    05 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    InflamEX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Neue Stiftingtalstrasse 6, Graz, Austria,
    Public contact
    Harald Kojzar (Project Coordinator), Medical University of Graz, harald.kojzar@medunigraz.at
    Scientific contact
    Prof. Dr. Harald Sourij (Principal Investigator), Medical University of Graz, ha.sourij@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
    26 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Difference in mean time in euglycemia 24 hours after exercise
    Protection of trial subjects
    ethical standards were followed, the trial adhere to strict ethical standards to ensure that participants were treated fairly and with respect protecting the privacy and confidentiality of participants education and training in protection of clinical trials participants for all study team members
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2017
    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
    		 Study participants were recruited using the subject database of our department

    Pre-assignment
    Screening details
    		 - Informed consent - Inclusion/Exclusion criteria - Demography - Participants diabetes history, current insulin therapy - Medical history, concomitant illness - Body measurements and vital signs - ECG - HbA1c measurement

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 -
    Arm type
    		 Baseline

    Investigational medicinal product name
    Insulin Degludec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Insulin Degludec administrated according to the investigator

    Number of subjects in period 1
    		Baseline
    Started
    10
    Completed
    10
    Period 2
    Period 2 title
    Intervention period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 100% Degudec
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Degludec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Insulin Degludec 100% as told by the investigator

    Arm title
    		 75% Degludec
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Degludec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Insulin Degludec 75% as told by the investigator

    Number of subjects in period 2
    		100% Degudec 75% Degludec
    Started
    5
    5
    Completed
    5
    4
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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

    Reporting group values
    		 Baseline 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)
    		 32.1 ( 9.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -
    Reporting group title
    100% Degudec
    Reporting group description
    		 -

    Reporting group title
    75% Degludec
    Reporting group description
    		 -

    Primary: Difference in mean time in euglycemia 24 hours after exercise

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    End point title
    		 Difference in mean time in euglycemia 24 hours after exercise
    End point description
    End point type
    Primary
    End point timeframe
    2 weeks (1 week per group)
    End point values
    		 100% Degudec 75% Degludec
    Number of subjects analysed
    5
    4
    Units: hours
        arithmetic mean (standard deviation)
    57 ( 14 )
    62 ( 15 )
    Statistical analysis title
    		 Crossover Trial Analysis
    Comparison groups
    100% Degudec v 75% Degludec
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 ANOVA
    Confidence interval

    Secondary: Numbers of confirmed hypoglycemic episodes during exercise (< 4.4 mmol/l

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    End point title
    		 Numbers of confirmed hypoglycemic episodes during exercise (< 4.4 mmol/l
    End point description
    End point type
    Secondary
    End point timeframe
    2 tweeks of training during the one hour exercise per day
    End point values
    		 100% Degudec 75% Degludec
    Number of subjects analysed
    5
    4
    Units: Hypo´s (blood sugar below 4,4 mmol/l)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event date was collected from 25.Oct.2017 (first patient first visit) until 02.Mar.2018 (last patient last visit).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    75% Degludec
    Reporting group description
    		 -

    Serious adverse events
    		 75% Degludec
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (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
    		 75% Degludec
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 1 (100.00%)
         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
    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.

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