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    Clinical Trial Results:
    Effect of glucagon-like peptide 1 (GLP-1) based diabetes medication on blood flow velocity in ischemic stroke patients

    Summary
    EudraCT number
    		 2016-001219-18
    Trial protocol
    		 DK  
    Global end of trial date
    06 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Nov 2025
    First version publication date
    05 Nov 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    E.G.R.A.B.I.S1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02829502
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Gentofte Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark,, 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
    27 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2023
    Was the trial ended prematurely?
    Yes
    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 and peripheral arterial function in individuals with ischemic stroke.
    Protection of trial subjects
    During the trial, participants were monitored hourly for heart rate and blood pressure. They were also asked about their general well-being and the occurrence of any side effects on an hourly basis. After completing the trial days, participants filled out a side effect form, which was then submitted to the investigator. Participants who were discharged from the department were provided with the phone number of the Department of Neurology, Herlev Gentofte Hospital (the sponsor), which they could call if they experienced any side effects or encountered any other issues.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 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: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    16
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Individuals with ischemic stroke were recruited from the stroke unit of the Department of Neurology, Copenhagen University Hospital – Herlev and Gentofte, Copenhagen, Denmark. Individuals were recruited between November 2016 and May 2023.

    Pre-assignment
    Screening details
    		 A medical doctor or student did the screening. Criteria: individuals aged 18 years or above, clinical and radiological confirmed ischemic stroke diagnosis. Could receive GLP-1-RA or placebo within 21 days of stroke onset. A NIHSS score between 1-20 at admission, a mRS score of 2 or lower, and capacity to provide informed consent.

    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
    A single subcutaneous dose of 5 µg (0.05 mL) exenatide (Byetta® Pen Injector, AstraZeneca) or a subcutaneous placebo (0.9% saline water, 0.05 mL) was administered. During administration, a registered nurse, not otherwise involved in the trial, administered the medication or placebo. Individuals with ischemic stroke were blindfolded and the investigator left the room during treatment being administered.

    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 (0.9% saline water) was given subcutaneously by a small syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Saline water
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.9% saline water, 0.05 mL

    Number of subjects in period 1
    		Exenatide Placebo
    Started
    13
    14
    Completed
    13
    14

    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
    		 27 27
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 61 (56 to 69.5) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 25 25

    End points

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    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 (0.9% saline water) was given subcutaneously by a small syringe

    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: Near-infrared spectroscopy (NIRS)

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    End point title
    		 Near-infrared spectroscopy (NIRS)
    End point description
    Changes in brain oxygen saturation 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 NIRS 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
    13
    13
    14
    14
    Units: rSO₂ (%)
        arithmetic mean (standard deviation)
    69.1 ( 4.9 )
    71.2 ( 6.4 )
    67.9 ( 6.4 )
    71.0 ( 4.8 )
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood pressure - systolic

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    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
    13
    13
    14
    14
    Units: mmHg
        arithmetic mean (standard deviation)
    145.0 ( 20.1 )
    151.5 ( 18.3 )
    141.7 ( 19.3 )
    147.1 ( 21.5 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood pressure - diastolic

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    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
    13
    13
    14
    14
    Units: mmHg
        arithmetic mean (standard deviation)
    83.8 ( 6.5 )
    84.6 ( 7.7 )
    88.0 ( 12.8 )
    90.9 ( 12.0 )
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: EndoPat - Regional hyperaemia index (RHI)

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    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
    11
    11
    12
    12
    Units: no unit
        arithmetic mean (standard deviation)
    2.3 ( 0.6 )
    2.6 ( 1.0 )
    1.9 ( 0.5 )
    2.1 ( 0.5 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    46
    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)

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    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
    11
    11
    12
    12
    Units: %
        arithmetic mean (standard deviation)
    21.8 ( 17.6 )
    20.8 ( 15.5 )
    12.3 ( 19.3 )
    14.3 ( 17.4 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Ankle brachial index

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    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
    13
    13
    14
    14
    Units: No unit
        arithmetic mean (standard deviation)
    1.1 ( 0.1 )
    1.1 ( 0.1 )
    1.1 ( 0.1 )
    1.1 ( 0.2 )
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Plasma glucose

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    End point title
    		 Plasma glucose
    End point description
    Changes in plasma 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
    Plasma 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
    13
    13
    14
    14
    Units: mmol/L
        arithmetic mean (standard deviation)
    5.8 ( 0.7 )
    4.9 ( 0.3 )
    5.8 ( 0.4 )
    5.5 ( 0.4 )
    Statistical analysis title
    		 T-test
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Insulin

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    End point title
    		 Insulin
    End point description
    Changes in insulin concentraton 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 different timepoints.
    End point type
    Secondary
    End point timeframe
    We performed 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
    13
    13
    14
    14
    Units: pmol/L
        arithmetic mean (standard deviation)
    58.2 ( 34.5 )
    56.1 ( 48.2 )
    81.0 ( 43.7 )
    61.5 ( 37.2 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: C-peptide

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    End point title
    		 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 and 180 minutes post-medication
    End point values
    		 Exenatide - baseline Exenatide - 180 minutes Placebo - baseline Placebo - 180 minutes
    Number of subjects analysed
    13
    13
    14
    14
    Units: pmol/L
        arithmetic mean (standard deviation)
    733.8 ( 307.7 )
    695.2 ( 363.5 )
    843.8 ( 345.0 )
    726.0 ( 294.1 )
    Statistical analysis title
    		 T-test
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - TNF

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    End point title
    		 Blood sample - TNF
    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
    13
    13
    14
    14
    Units: pg/mL
        arithmetic mean (standard deviation)
    1.992 ( 0.431 )
    2.276 ( 1.122 )
    1.793 ( 0.707 )
    1.985 ( 0.829 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - IL-6

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    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
    13
    13
    14
    14
    Units: pg/mL
        arithmetic mean (standard deviation)
    2.846 ( 3.173 )
    3.372 ( 2.629 )
    2.742 ( 3.199 )
    3.536 ( 4.025 )
    Statistical analysis title
    		 T-test
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - IL-1beta

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    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
    13
    13
    14
    14
    Units: pg/mL
        arithmetic mean (standard deviation)
    0.516 ( 0.298 )
    0.315 ( 0.332 )
    0.220 ( 0.178 )
    0.760 ( 1.406 )
    Statistical analysis title
    		 T-test
    Comparison groups
    Exenatide - baseline v Exenatide - 180 minutes v Placebo - baseline v Placebo - 180 minutes
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - VCAM1

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    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
    13
    13
    14
    14
    Units: ng/mL
        arithmetic mean (standard deviation)
    3262963 ( 3191765 )
    2744889 ( 2338746 )
    1979060 ( 1463873 )
    1766864 ( 1318127 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Blood sample - ICAM-1

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    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
    13
    13
    14
    14
    Units: ng/mL
        arithmetic mean (standard deviation)
    2626802 ( 2472003 )
    2162964 ( 1757315 )
    1724145 ( 1183808 )
    1622428 ( 1159442 )
    Statistical analysis title
    		 T-test
    Statistical analysis description
    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
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    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
    During the whole trial period.
    Adverse event reporting additional description
    Questionaire given to participants. Participants 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
    		 -

    Serious adverse events
    		 Exenatide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Exenatide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 13 (61.54%)
    7 / 14 (50.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 13 (15.38%)
    3 / 14 (21.43%)
         occurrences all number
    2
    3
    Dizziness
         subjects affected / exposed
    3 / 13 (23.08%)
    4 / 14 (28.57%)
         occurrences all number
    3
    4
    General disorders and administration site conditions
    Weakness/fatigue
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 14 (7.14%)
         occurrences all number
    3
    1
    Bloating
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Acid reflux
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2

    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? Yes
    Date
    Interruption
    Restart date
    01 May 2018
    IPeriod where the trial was inactive due to nvestigator change
    02 Aug 2020
    21 Mar 2020
    COVID-19 pandemic, which posed challenges for recruitment due to social distancing measures, resulting in delays in the study timeline.
    01 Feb 2021

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
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