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:
    Effect of glucagon-like peptide 1 (GLP-1) based diabetes medication on blood flow velocity in persons without cerebrovascular disease.

    Summary
    EudraCT number
    		 2016-001221-14
    Trial protocol
    		 DK  
    Global end of trial date
    02 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2020
    First version publication date
    21 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    E.G.R.A.B.I.N.S1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02838589
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Gentofte Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
    Public contact
    Christina Rostrup Kruuse, Herlev Gentofte Hospital, 45 38681233 , christina.rostrup.kruuse@regionh.dk
    Scientific contact
    Christina Rostrup Kruuse, Herlev Gentofte Hospital, 45 38681233 , christina.rostrup.kruuse@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
    07 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to investigate the effect of a single dose of 5 mikrogram GLP-1 receptor agonist (exenatide) on cerebral blood flow velocity in humans without cerebrovascular disease.
    Protection of trial subjects
    During the trial days, trial participants were monitored thoroughly with heart rate and blood pressure. They were asked how they felt every hour during the trial days and if they experienced any side effects. After the trial days, they were asked to complete a side effect form and then hand it in to the investigator. They were also given the phone number to the Department of Neurology, Herlev Gentofte Hospital (sponsor) which they could call to if they experienced any side effects or had any other trouble. If the participants experienced pain or distress during the trial days, we talked about it and tried to accomodate their wishes to see if we could minimize pain.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Aug 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
    Denmark: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    25
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited from "http://www.forsoegsperson.dk", "www.sundhed.dk", and through advertisement. Participants were recruited year 2016 and 2017.

    Pre-assignment
    Screening details
    		 Screening was done by a medical doctor and a medical student.

    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
    Blinding implementation details
    Exenatide was given sub-cutaneus by standard medication-pen. Placebo was given sub-cutaneus by a small syringe with a matching needle. Medication/placebo were given by a study nurse who was not blinded. The study nurse was not implemented in other parts of the trial. The participants were blindfolded when medication and placebo were delivered. Hence, investigator, subjects, data analyst and monitor were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Exenatide
    Arm description
    		 Parallel-arm trial. Exenatide (5 ug) was given as a single dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    Byetta
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage: 5 micrograms (ug) Administration details: Sub-cutaneus injection by pen

    Arm title
    		 Placebo
    Arm description
    		 Placebo (isotonic salt-water) was given sub-cutaneus by a small syrringe.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dosage: 0,05 ml Administration detail: Sub-cutaneus injection

    Number of subjects in period 1
    		Exenatide Placebo
    Started
    21
    15
    Completed
    15
    15
    Not completed
    6
    0
         Medication failure
    6
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 36 36
    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)
    		 25 25
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.3 ± 7.7 -
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 18 18

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Exenatide
    Reporting group description
    		 Parallel-arm trial. Exenatide (5 ug) was given as a single dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (isotonic salt-water) was given sub-cutaneus by a small syrringe.

    Subject analysis set title
    Exenatide - baseline
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Exenatide group at baseline

    Subject analysis set title
    Exenatide - 180 minutes
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Exenatide group at 180 minutes.

    Subject analysis set title
    Placebo - baseline
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Placebo group at baseline.

    Subject analysis set title
    Placebo - 180 minutes
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Placebo group at 180 minutes.

    Primary: Transcranial Doppler

    		 Close Top of page
    End point title
    		 Transcranial Doppler
    End point description
    Changes in mean blood flow velocity in the middle cerebral artery before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Primary
    End point timeframe
    We performed TCD measurements at baseline and 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: cm/sec
        arithmetic mean (standard deviation)
    68.5 ± 11.5
    68.7 ± 12.1
    61.8 ± 9.1
    65.8 ± 12.9
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood pressure - diastolic

    		 Close Top of page
    End point title
    		 Blood pressure - diastolic
    End point description
    Changes in blood pressure before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed blood pressure measurements at baseline and 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: mmHg
        arithmetic mean (standard deviation)
    77.9 ± 11.3
    80.3 ± 12.2
    77.5 ± 6.1
    80.7 ± 8.9
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood pressure - systolic

    		 Close Top of page
    End point title
    		 Blood pressure - systolic
    End point description
    Changes in blood pressure before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed blood pressure measurements at baseline and 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: mmHg
        arithmetic mean (standard deviation)
    133.9 ± 19.4
    137.5 ± 20.1
    129.2 ± 10.2
    135.4 ± 14.2
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: EndoPat - Regional hyperaemia index (RHI)

    		 Close Top of page
    End point title
    		 EndoPat - Regional hyperaemia index (RHI)
    End point description
    Changes in regional hyperemia index before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed EndoPAT measurements at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: no unit
        arithmetic mean (standard deviation)
    2.0 ± 0.5
    2.2 ± 0.5
    2.0 ± 0.3
    2.3 ± 0.4
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: EndoPat - augmentation index standardized to a heart rate of 75 (AI@75)

    		 Close Top of page
    End point title
    		 EndoPat - augmentation index standardized to a heart rate of 75 (AI@75)
    End point description
    Changes in EndoPAT - augmentation index standardized to a heart rate of 75 before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed EndoPAT measurements at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: no unit
        arithmetic mean (standard deviation)
    11.3 ± 14.1
    12.8 ± 15.2
    1.9 ± 12.6
    4.5 ± 13.6
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Ankle brachial index

    		 Close Top of page
    End point title
    		 Ankle brachial index
    End point description
    Changes in ankel brachial index before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed ankle brachial index measurements at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: mmHg
        arithmetic mean (standard deviation)
    1.1 ± 0.1
    1.1 ± 0.1
    1.2 ± 0.1
    1.2 ± 0.1
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - 180 minutes v Placebo - baseline v Exenatide - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood glucose

    		 Close Top of page
    End point title
    		 Blood glucose
    End point description
    Changes in blood glucose before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood glucose were collected at baseline180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: mmol/l
        arithmetic mean (standard deviation)
    5.5 ± 0.5
    4.9 ± 0.3
    5.4 ± 0.5
    5.22 ± 0.4
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Placebo - baseline v Exenatide - 180 minutes v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood insulin

    		 Close Top of page
    End point title
    		 Blood insulin
    End point description
    Changes in blood insulin before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed blood insulin measurements at baseline and 180 minutes postmedication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pmol/l
        arithmetic mean (standard deviation)
    42.5 ± 47.3
    41.2 ± 31.0
    32.8 ± 19.6
    34.5 ± 18.0
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Placebo - baseline v Exenatide - 180 minutes v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood c-peptide

    		 Close Top of page
    End point title
    		 Blood c-peptide
    End point description
    Blood c-peptide before exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at baseline.
    End point type
    Secondary
    End point timeframe
    We performed blood c-peptide measurments at baseline.
    End point values
    		 Exenatide - baseline Placebo - baseline
    Number of subjects analysed
    15
    15
    Units: pmol/l
        arithmetic mean (standard deviation)
    459.2 ± 238.2
    404.0 ± 159.1
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Placebo - baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - E-selectin

    		 Close Top of page
    End point title
    		 Blood sample - E-selectin
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    4429.7 ± 1859.4
    4047.7 ± 2477.5
    4208.9 ± 2555.4
    4348.4 ± 2915.7
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - TNF-alpha

    		 Close Top of page
    End point title
    		 Blood sample - TNF-alpha
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    1.8 ± 0.8
    1.9 ± 0.7
    1.6 ± 0.4
    1.4 ± 0.4
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - IL-6

    		 Close Top of page
    End point title
    		 Blood sample - IL-6
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    0.8 ± 0.5
    1.8 ± 0.9
    0.8 ± 0.4
    1.8 ± 1.1
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - IL-1beta

    		 Close Top of page
    End point title
    		 Blood sample - IL-1beta
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    0.07 ± 0.2
    0.03 ± 0.1
    0.01 ± 0.03
    0.01 ± 0.03
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - VCAM1

    		 Close Top of page
    End point title
    		 Blood sample - VCAM1
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    1079734.5 ± 316840.2
    1088737.9 ± 333159.7
    1171249.3 ± 574173.7
    1006405.1 ± 371746.1
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - ICAM-1

    		 Close Top of page
    End point title
    		 Blood sample - ICAM-1
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    730279.6 ± 143120.0
    747610.5 ± 152708.8
    694218.7 ± 328253.2
    698376.5 ± 306442.4
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - VEGF

    		 Close Top of page
    End point title
    		 Blood sample - VEGF
    End point description
    Changes in biomarker concentration before and after exenatide/placebo for each subject were calculated and then further used for statistical analysis. Here, results are shown as the mean value and standard deviation for both groups at the different timepoints.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected at baseline and after 180 minutes post-medication.
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    15
    15
    15
    15
    Units: pg/ml
        arithmetic mean (standard deviation)
    22.2 ± 11.9
    29.3 ± 18.6
    21.7 ± 12.3
    25.0 ± 16.5
    Statistical analysis title
    		 T-test
    Statistical analysis description
    We performed a paired sample T-test.
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    During the whole trial period.
    Adverse event reporting additional description
    Questionaire given to subjects. Subjects were asked to note all adverse events for 24 hours after medication administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Events not coded
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Exenatide
    Reporting group description
    		 Exenatide (5 ug), single dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, single dose.

    Reporting group title
    Exenatide - medication failure
    Reporting group description
    		 Patients who were supposed to recieve exenatide, but medication were given incorrectly which resulted in that no medication or a low dose were given instead.

    Serious adverse events
    		 Exenatide Placebo Exenatide - medication failure
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Exenatide Placebo Exenatide - medication failure
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    7 / 15 (46.67%)
    2 / 6 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 15 (53.33%)
    5 / 15 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    8
    5
    1
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    General disorders and administration site conditions
    Temperature perception increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Light-headedness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Uneasy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 15 (20.00%)
    3 / 15 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    3
    3
    2
    Abdominal pain
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Flatulence
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Psychiatric disorders
    Fatigue
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    1 / 6 (16.67%)
         occurrences all number
    3
    2
    1

    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 21:23:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA