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    Clinical Trial Results:
    Open Label Pilot Trial in patients with recent-onset T1D to evaluate the safety, diabetes status and immune response of GAD-antigen (Diamyd®) therapy administered into lymph nodes in combination with an oral vitamin D regimen

    Summary
    EudraCT number
    		 2014-001417-79
    Trial protocol
    		 SE  
    Global end of trial date
    08 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2020
    First version publication date
    07 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DIAGNODE-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02352974
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Linköping University
    Sponsor organisation address
    Div of Pediatrics, Linköping, Sweden, 581 85
    Public contact
    Johnny Ludvigsson, Linköping University, johnny.ludvigsson@liu.se
    Scientific contact
    Johnny Ludvigsson, Linköping University, johnny.ludvigsson@liu.se
    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
    28 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • Evaluate the safety of giving Diamyd directly into lymph glands in combination with an oral vitamin D regimen • Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion
    Protection of trial subjects
    After the injection of GAD-Alum (Diamyd) at Visits 3, 4 and 5, each patient was to remain in the vicinity of the study site for the next hour, and the injection site was examined by the investigator/study nurse 1 hour post injection.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2014
    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
    Sweden: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    4
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 20 patients were screened. All 8 screening failures were due to eligibility criteria not met. 12 patients were enrolled in the main study period and 3 of them continued in the extension period.

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

    Arms
    Arm title
    		 GAD-Alum+Vitamin D
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Intralymphatic injections of GAD-alum (Diamyd®) 4 μg on Days 30, 60 and 90.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    Vitamin D per os (2 000 IU) daily for 120 days

    Number of subjects in period 1
    		GAD-Alum+Vitamin D
    Started
    12
    Completed
    12
    Period 2
    Period 2 title
    Main study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 GAD-Alum+Vitamin D
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Intralymphatic injections of GAD-alum (Diamyd®) 4 μg on Days 30, 60 and 90.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    Vitamin D per os (2 000 IU) daily for 120 days

    Number of subjects in period 2
    		GAD-Alum+Vitamin D
    Started
    12
    Completed
    12
    Period 3
    Period 3 title
    Extension
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 GAD-Alum+Vitamin D
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Intralymphatic injections of GAD-alum (Diamyd®) 4 μg on Days 30, 60, 90 and Month 32.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    Vitamin D per os (2 000 IU) daily for 120 days after first injection and 60 days after last injection

    Number of subjects in period 3 [1]
    		GAD-Alum+Vitamin D
    Started
    3
    Completed
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only 3 patients of the 12 continued in to the extension period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GAD-Alum+Vitamin D
    Reporting group description
    		 -

    Reporting group values
    		 GAD-Alum+Vitamin D Total
    Number of subjects
    		 12 12
    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)
    		 4 4
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 18.8 ( 4.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 8 8
    Weight
    Units: Kilo
        arithmetic mean (standard deviation)
    		 64 ( 13.6 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 173.8 ( 9.9 ) -
    BMI
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 21.1 ( 3.8 ) -
    GADA
    Units: (U/mL)2
        arithmetic mean (standard deviation)
    		 4067.1 ( 8491.6 ) -
    HbA1C
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 67.17 ( 28.17 ) -
    Average insulin dose/kg/24 h
    Units: IU
        arithmetic mean (standard deviation)
    		 0.4 ( 0.2 ) -
    Weighted C-peptide
    Units: nmol/l
        arithmetic mean (standard deviation)
    		 0.55 ( 0.19 ) -
    90-minute C-peptide
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 0.67 ( 0.19 ) -
    Fasting C-peptide
    Units: nmol/L
        arithmetic mean (standard deviation)
    		 0.27 ( 0.08 ) -
    IDAA1c
    Units: HbA1c(%)+4*insulin dose
        arithmetic mean (standard deviation)
    		 9.91 ( 3.10 ) -
    Type 1 diabetes duration
    Units: days
        arithmetic mean (standard deviation)
    		 65.1 ( 55.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    GAD-Alum+Vitamin D
    Reporting group description
    		 -
    Reporting group title
    GAD-Alum+Vitamin D
    Reporting group description
    		 -
    Reporting group title
    GAD-Alum+Vitamin D
    Reporting group description
    		 -

    Primary: Injection site reactions month 1

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    End point title
    		 Injection site reactions month 1 [1]
    End point description
    End point type
    Primary
    End point timeframe
    At Month 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a one arm study with few patients and no formal statistical analyses have been planned or performed.
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    Units: Number of subjects
        Erythema
    0
        Oedema
    0
        Haematoma
    0
        Tenderness
    1
        Pain
    0
        Itching
    0
        Other
    0
    No statistical analyses for this end point

    Primary: Injection site reactions month 2

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    End point title
    		 Injection site reactions month 2 [2]
    End point description
    End point type
    Primary
    End point timeframe
    At Month 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a one arm study with few patients and no formal statistical analyses have been planned or performed.
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    Units: Number of subjects
        Erythema
    0
        Oedema
    0
        Haematoma
    0
        Tenderness
    1
        Pain
    0
        Itching
    0
        Other
    0
    No statistical analyses for this end point

    Primary: Injection site reactions month 3

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    End point title
    		 Injection site reactions month 3 [3]
    End point description
    End point type
    Primary
    End point timeframe
    At Month 3
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a one arm study with few patients and no formal statistical analyses have been planned or performed.
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    Units: Number of subjects
        Erythema
    0
        Oedema
    0
        Haematoma
    0
        Tenderness
    2
        Pain
    0
        Itching
    0
        Other
    0
    No statistical analyses for this end point

    Primary: Injection site reactions month 32

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    End point title
    		 Injection site reactions month 32 [4]
    End point description
    End point type
    Primary
    End point timeframe
    At Month 32
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a one arm study with few patients and no formal statistical analyses have been planned or performed.
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: Number of subjects
        Erythema
    0
        Oedema
    0
        Haematoma
    0
        Tenderness
    0
        Pain
    0
        Itching
    0
        Other
    0
    No statistical analyses for this end point

    Secondary: Mean change in C-peptide AUC (mean 0-120 min) from baseline to month 15

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    End point title
    		 Mean change in C-peptide AUC (mean 0-120 min) from baseline to month 15
    End point description
    Changes from baseline
    End point type
    Secondary
    End point timeframe
    Baseline to Month 15
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.11 ( 0.12 )
    -0.10 ( 0.05 )
    No statistical analyses for this end point

    Secondary: Mean change in C-peptide AUC (mean 0-120 min) from baseline to month 30

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    End point title
    		 Mean change in C-peptide AUC (mean 0-120 min) from baseline to month 30
    End point description
    Change from baseline
    End point type
    Secondary
    End point timeframe
    Baseline to month 30
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.22 ( 0.16 )
    -0.13 ( 0.06 )
    No statistical analyses for this end point

    Secondary: Mean change in C-peptide 90 minute values from baseline to month 15

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    End point title
    		 Mean change in C-peptide 90 minute values from baseline to month 15
    End point description
    Change from baseline
    End point type
    Secondary
    End point timeframe
    Baseline to month 15
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.16 ( 0.15 )
    -0.20 ( 0.07 )
    No statistical analyses for this end point

    Secondary: Mean change in C-peptide 90-minute values from baseline to month 30

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    End point title
    		 Mean change in C-peptide 90-minute values from baseline to month 30
    End point description
    Change from baseline
    End point type
    Secondary
    End point timeframe
    Baseline to month 30
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.29 ( 0.17 )
    -0.17 ( 0.17 )
    No statistical analyses for this end point

    Secondary: Mean change in C-peptide 90 minute values from baseline to month 43

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    End point title
    		 Mean change in C-peptide 90 minute values from baseline to month 43
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 43
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.16 ( 0.03 )
    No statistical analyses for this end point

    Secondary: Mean change in fasting C-peptide from baseline to month 15

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    End point title
    		 Mean change in fasting C-peptide from baseline to month 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 15
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.03 ( 0.12 )
    0.00 ( 0.07 )
    No statistical analyses for this end point

    Secondary: Mean change in fasting C-peptide from baseline to month 30

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    End point title
    		 Mean change in fasting C-peptide from baseline to month 30
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 30
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.10 ( 0.12 )
    -0.10 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Mean change in fasting C-peptide from baseline to month 43

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    End point title
    		 Mean change in fasting C-peptide from baseline to month 43
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 43
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.07 ( 0.04 )
    No statistical analyses for this end point

    Secondary: Mean change in HbA1c from baseline to month 15

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    End point title
    		 Mean change in HbA1c from baseline to month 15
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 15
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: mmol/mol
        arithmetic mean (standard deviation)
    -14.25 ( 18.91 )
    -32.00 ( 27.06 )
    No statistical analyses for this end point

    Secondary: Mean change in HbA1c from baseline to month 30

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    End point title
    		 Mean change in HbA1c from baseline to month 30
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 30
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: mmol/mol
        arithmetic mean (standard deviation)
    -10.67 ( 18.67 )
    -31.67 ( 20.21 )
    No statistical analyses for this end point

    Secondary: Mean change in HbA1c from baseline to month 43

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    End point title
    		 Mean change in HbA1c from baseline to month 43
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Month 43
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: mmol/mol
        arithmetic mean (standard deviation)
    -30.67 ( 21.22 )
    No statistical analyses for this end point

    Secondary: External insulin dose at baseline

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    End point title
    		 External insulin dose at baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    0.36 ( 0.13 )
    0.35 ( 0.17 )
    No statistical analyses for this end point

    Secondary: External insulin dose month 15

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    End point title
    		 External insulin dose month 15
    End point description
    End point type
    Secondary
    End point timeframe
    Month 15
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    0.34 ( 0.2 )
    0.16 ( 0.15 )
    No statistical analyses for this end point

    Secondary: External insulin dose month 30

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    End point title
    		 External insulin dose month 30
    End point description
    End point type
    Secondary
    End point timeframe
    Month 30
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    0.44 ( 0.22 )
    0.35 ( 0.20 )
    No statistical analyses for this end point

    Secondary: External insulin dose month 43

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    End point title
    		 External insulin dose month 43
    End point description
    End point type
    Secondary
    End point timeframe
    Month 43
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    0.25 ( 0.02 )
    No statistical analyses for this end point

    Secondary: IDAA1c at baseline

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    End point title
    		 IDAA1c at baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    9.00 ( 1.89 )
    10.34 ( 3.12 )
    No statistical analyses for this end point

    Secondary: IDAA1c month 15

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    End point title
    		 IDAA1c month 15
    End point description
    End point type
    Secondary
    End point timeframe
    Month 15
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    7.64 ( 0.99 )
    6.63 ( 0.84 )
    No statistical analyses for this end point

    Secondary: IDAA1c month 30

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    End point title
    		 IDAA1c month 30
    End point description
    End point type
    Secondary
    End point timeframe
    Month 30
    End point values
    		 GAD-Alum+Vitamin D GAD-Alum+Vitamin D
    Number of subjects analysed
    12
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    8.36 ( 1.28 )
    7.41 ( 1.41 )
    No statistical analyses for this end point

    Secondary: IDAA1c month 43

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    End point title
    		 IDAA1c month 43
    End point description
    End point type
    Secondary
    End point timeframe
    Month 43
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: IU/kg/day
        arithmetic mean (standard deviation)
    7.11 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Mean change in C-peptide AUC (mean 0-120 min) from baseline to month 43

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    End point title
    		 Mean change in C-peptide AUC (mean 0-120 min) from baseline to month 43
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to month 43
    End point values
    		 GAD-Alum+Vitamin D
    Number of subjects analysed
    3
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.13 ( 0.05 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Main study period and extension
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    GAD-Alum+Vitamin D
    Reporting group description
    		 -

    Serious adverse events
    		 GAD-Alum+Vitamin D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (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
    		 GAD-Alum+Vitamin D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injection site pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Injection site reaction
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Autism spectrum disorder
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Panic disorder
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Sleep disorder
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Fibula fracture
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Joint dislocation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Skin injury
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Eye disorders
    Retinopathy
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Bowel movement irregularity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Food poisoning
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    3
    Toothache
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Ingrowing nail
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    35
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Viral infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2016
    * Removed a co-investigator. * Included pediatric patients (12-18) in the study * Increased number of study patients from 5 to 9
    29 Aug 2016
    * Added a co-investigator * Increased the number of study patients from 9 to approximately 15 * Increased the number of sites from 1 to 2
    22 Jan 2018
    * Added the fourth GAD-alum (Diamyd) injection (i.e. the prolonged extension period) in 4 adult patients.
    05 Apr 2018
    * Changed the fourth GAD-alum (Diamyd) injection (i.e. the prolonged extension period) to be 3 adult patients * Fine-tuned the assessments of height for pubertal stage for pediatric patients and required insulin dose to be collected 4 days prior to each visit

    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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