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    Clinical Trial Results:
    Pilot Trial to preserve residual insulin secretion in children and adolescents with recent onset Type 1 diabetes by using GAD-antigen (Diamyd) therapy in combination with Vitamin D and Ibuprofen .

    Summary
    EudraCT number
    		 2012-003251-11
    Trial protocol
    		 SE  
    Global end of trial date
    30 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2017
    First version publication date
    14 Jun 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DIABGAD-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Div of Pediatrics, Dept of Clinical and Experimental Medicine, Faculty of Health Medicine
    Sponsor organisation address
    Linköping University, Linköping, Sweden, SE-581 85
    Public contact
    Johnny Ludvigsson, Linköping University, 46 13286854, Johnny.Ludvigsson@liu.se
    Scientific contact
    Johnny Ludvigsson, Linköping University, 46 13286854, 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
    30 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • Evaluate the safety and influence of treatment with GAD-Alum (Diamyd) plus Vitamin D plus Ibuprofen on preservation of residual insulin secretion in recently-diagnosed Type 1 diabetes. • Evaluate how the abovementioned treatments influencers the immune system of the patients and interact with any viral infections. • Evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections and on preservation of residual insulin secretion in recently-diagnosed Type 1 diabetes
    Protection of trial subjects
    After the injection of GAD-Alum (Diamyd)/Placebo at Visit 3 and 4, the patient was to remain in the vicinity of the study site for the next hour, and the injection site were examined by investigator/study nurse 1 hour post injection.
    Background therapy
    		 Standard insulin treatment, education and psycho-social support for newly diagnosed Type 1 diabetes patients. All patients will continue to receive standard care for Type 1 diabetes during the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    17
    Adolescents (12-17 years)
    47
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited from January 2013 to May 2014. Patients were recruited at 9 hospitals in Sweden.

    Pre-assignment
    Screening details
    		 Patients aged 10.00 to 17.99 years at the time of screening and with Type 1 diabetes according to the ADA classification with < 4 months diabetes duration at time of screening.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients will be assigned to receive Ibuprofen as oral suspension; 400 mg every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The comercially available Vitamin D, calciferol. Vitamin D was administered as oral solution ; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450.

    Investigational medicinal product name
    Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    The commercially available ibuprofen. Ibuprofen was administered as oral suspension; 400 mg every morning from Day 1 through 90.

    Arm title
    		 Group B
    Arm description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The comercially available Vitamin D, calciferol. Vitamin D was administered as oral solution ; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450.

    Investigational medicinal product name
    Placebo Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo ibuprofen was administered as oral suspension; every morning from Day 1 through 90.

    Arm title
    		 Group C
    Arm description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 2 subcutaneous injections with 20 μg Diamyd given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster doses (providing a total dose of 80μg Diamyd).
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The comercially available Vitamin D, calciferol. Vitamin D was administered as oral solution ; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450.

    Investigational medicinal product name
    Placebo Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo ibuprofen was administered as oral suspension; every morning from Day 1 through 90.

    Arm title
    		 Group D
    Arm description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and placebo oral drops from Day 1 through 450, and 2 subcutaneous injections with placebo (given at two different sites in the stomach area), each on Days 15 and 45
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered as oral solution i.e. 25 drops per day from Day 1 through Day 450.

    Investigational medicinal product name
    Placebo Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo ibuprofen was administered as oral suspension; every morning from Day 1 through 90.

    Number of subjects in period 1
    		Group A Group B Group C Group D
    Started
    16
    16
    16
    16
    Completed
    16
    16
    16
    16
    Period 2
    Period 2 title
    Baseline to Month 30
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    The treatment code was broken 24 March 2015, and data from Visit 1 to Visit 6 (6 months) were made available to one representative from the Sponsor (unblinded statistician), and the drug supplier (Diamyd Medical). The study was kept blinded to patients, investigators and study personnel until study completion.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients will be assigned to receive Ibuprofen as oral suspension; 400 mg every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The comercially available Vitamin D, calciferol. Vitamin D was administered as oral solution ; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450.

    Investigational medicinal product name
    Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    The commercially available ibuprofen. Ibuprofen was administered as oral suspension; 400 mg every morning from Day 1 through 90.

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd injection. Diamyd 20 µg was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). The Diamyd® Drug Product was composed of the rhGAD65 protein formulated in a sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. Diamyd® was administered as a 0.5 mL subcutaneous injection. Each injection contained 20 µg Diamyd® protein.

    Investigational medicinal product name
    Placebo Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd placebo injection containing 0 ug Diamyd. Diamyd placebo was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). A sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. 0.5 mL subcutaneous injection.

    Arm title
    		 Group B
    Arm description
    		 Patients will be assigned to receive placebo ibuprofen as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The comercially available Vitamin D, calciferol. Vitamin D was administered as oral solution ; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450.

    Investigational medicinal product name
    Placebo Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo ibuprofen was administered as oral suspension; every morning from Day 1 through 90.

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd injection. Diamyd 20 µg was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). The Diamyd® Drug Product was composed of the rhGAD65 protein formulated in a sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. Diamyd® was administered as a 0.5 mL subcutaneous injection. Each injection contained 20 µg Diamyd® protein.

    Investigational medicinal product name
    Placebo Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd placebo injection containing 0 ug Diamyd. Diamyd placebo was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). A sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. 0.5 mL subcutaneous injection.

    Arm title
    		 Group C
    Arm description
    		 Patients will be assigned to receive placebo ibuprofen as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 2 subcutaneous injections with 20 μg Diamyd given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster doses (providing a total dose of 80μg Diamyd).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo ibuprofen was administered as oral suspension; every morning from Day 1 through 90.

    Investigational medicinal product name
    D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The comercially available Vitamin D, calciferol. Vitamin D was administered as oral solution ; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450.

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd injection. Diamyd 20 µg was administered as subcutaneous injections, on Days 15 and 45 (prime and booster dose). The Diamyd® Drug Product was composed of the rhGAD65 protein formulated in a sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. Diamyd® was administered as a 0.5 mL subcutaneous injection. Each injection contained 20 µg Diamyd® protein.

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd injection. Diamyd 20 µg was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). The Diamyd® Drug Product was composed of the rhGAD65 protein formulated in a sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. Diamyd® was administered as a 0.5 mL subcutaneous injection. Each injection contained 20 µg Diamyd® protein.

    Arm title
    		 Group D
    Arm description
    		 Patients will be assigned to receive placebo ibuprofen as oral suspension every morning from Day 1 through 90 and placebo oral drops from Day 1 through 450, and 2 subcutaneous injections with placebo (given at two different sites in the stomach area), each on Days 15 and 45
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Ibuprofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo ibuprofen was administered as oral suspension; every morning from Day 1 through 90.

    Investigational medicinal product name
    Placebo D-vitamin Oil
    Investigational medicinal product code
    Other name
    Calciferol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered as oral solution i.e. 25 drops per day from Day 1 through Day 450.

    Investigational medicinal product name
    Placebo Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd placebo injection containing 0 ug Diamyd. Diamyd placebo was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). A sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. 0.5 mL subcutaneous injection.

    Investigational medicinal product name
    Placebo Diamyd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 x Diamyd placebo injection containing 0 ug Diamyd. Diamyd placebo was administered as subcutaneous injections on Days 15 and 45 (prime and booster dose). A sterile, non-pyrogenic phosphate buffered saline containing the aluminum hydroxide adjuvant, Alhydrogel®. 0.5 mL subcutaneous injection.

    Number of subjects in period 2 [1]
    		Group A Group B Group C Group D
    Started
    16
    16
    16
    15
    Prime injection Diamyd/Placebo
    16
    16
    16
    15
    Boost injection Diamyd/Placebo
    16
    16
    15
    15
    Completed 6 month visit
    16
    16
    15
    13
    Completed 15 month visit
    15
    16
    15
    13
    Completed 30 month visit
    15
    16
    15
    13
    Completed
    15
    16
    15
    13
    Not completed
    1
    0
    1
    2
         Consent withdrawn by subject
    1
    -
    1
    1
         Physician decision
    -
    -
    -
    1
    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: 1 patient in Group D completed Baseline but decided not to continue in the study after baseline visit.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients will be assigned to receive Ibuprofen as oral suspension; 400 mg every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group B
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group C
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 2 subcutaneous injections with 20 μg Diamyd given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster doses (providing a total dose of 80μg Diamyd).

    Reporting group title
    Group D
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and placebo oral drops from Day 1 through 450, and 2 subcutaneous injections with placebo (given at two different sites in the stomach area), each on Days 15 and 45

    Reporting group values
    		 Group A Group B Group C Group D Total
    Number of subjects
    		 16 16 16 16 64
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 5 4 6 2 17
        Adolescents (12-17 years)
    		 11 12 10 14 47
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.3 ( 1.9 ) 14.4 ( 2.7 ) 13.3 ( 2.4 ) 14.2 ( 2.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 7 10 9 32
        Male
    		 10 9 6 7 32

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients will be assigned to receive Ibuprofen as oral suspension; 400 mg every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group B
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group C
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 2 subcutaneous injections with 20 μg Diamyd given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster doses (providing a total dose of 80μg Diamyd).

    Reporting group title
    Group D
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and placebo oral drops from Day 1 through 450, and 2 subcutaneous injections with placebo (given at two different sites in the stomach area), each on Days 15 and 45
    Reporting group title
    Group A
    Reporting group description
    		 Patients will be assigned to receive Ibuprofen as oral suspension; 400 mg every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group B
    Reporting group description
    		 Patients will be assigned to receive placebo ibuprofen as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group C
    Reporting group description
    		 Patients will be assigned to receive placebo ibuprofen as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 2 subcutaneous injections with 20 μg Diamyd given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster doses (providing a total dose of 80μg Diamyd).

    Reporting group title
    Group D
    Reporting group description
    		 Patients will be assigned to receive placebo ibuprofen as oral suspension every morning from Day 1 through 90 and placebo oral drops from Day 1 through 450, and 2 subcutaneous injections with placebo (given at two different sites in the stomach area), each on Days 15 and 45

    Primary: Change in AUC for C-peptide from baseline to month 6

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    End point title
    		 Change in AUC for C-peptide from baseline to month 6 [1]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to 6 months
    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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    11
    15
    14
    10
    Units: AUC for C-peptide (nmol/L
        arithmetic mean (standard deviation)
    -0.264 ( 0.231 )
    -0.114 ( 0.164 )
    -0.19 ( 0.161 )
    0.008 ( 0.271 )
    No statistical analyses for this end point

    Primary: Change in AUC for C-peptide from baseline to month 15

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    End point title
    		 Change in AUC for C-peptide from baseline to month 15 [2]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to Month 15
    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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    11
    15
    14
    10
    Units: AUC for C-peptide (nmol/L)
        arithmetic mean (standard deviation)
    -0.362 ( 0.243 )
    -0.195 ( 0.167 )
    -0.277 ( 0.216 )
    -0.273 ( 0.245 )
    No statistical analyses for this end point

    Primary: Change in AUC for C-peptide from baseline to month 30

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    End point title
    		 Change in AUC for C-peptide from baseline to month 30 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Month 30
    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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    10
    14
    14
    11
    Units: AUC for C-peptide (nmol/L)
        arithmetic mean (standard deviation)
    -0.512 ( 0.318 )
    -0.383 ( 0.161 )
    -0.458 ( 0.209 )
    -0.405 ( 0.257 )
    No statistical analyses for this end point

    Primary: Change in mean fasting C-peptide, baseline to month 6

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    End point title
    		 Change in mean fasting C-peptide, baseline to month 6 [4]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Visit 6
    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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    11
    15
    14
    10
    Units: Mean fasting C-peptide (nmol/L)
        arithmetic mean (standard deviation)
    -0.108 ( 0.195 )
    -0.015 ( 0.143 )
    -0.068 ( 0.133 )
    0.023 ( 0.191 )
    No statistical analyses for this end point

    Primary: Change in mean fasting C-peptide, baseline to month 15

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    End point title
    		 Change in mean fasting C-peptide, baseline to month 15 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to month 15
    Notes
    [5] - 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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    11
    15
    14
    10
    Units: Mean fasting C-peptide (nmol/L)
        arithmetic mean (standard deviation)
    -0.131 ( 0.166 )
    -0.061 ( 0.143 )
    -0.142 ( 0.133 )
    -0.039 ( 0.185 )
    No statistical analyses for this end point

    Primary: Change in mean fasting C-peptide, baseline to month 30

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    End point title
    		 Change in mean fasting C-peptide, baseline to month 30 [6]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to month 30
    Notes
    [6] - 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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    10
    14
    14
    11
    Units: Mean fasting C-peptide (nmol/L)
        arithmetic mean (standard deviation)
    -0.194 ( 0.204 )
    -0.134 ( 0.133 )
    -0.203 ( 0.124 )
    -0.13 ( 0.117 )
    No statistical analyses for this end point

    Primary: Change in HbA1c from baseline to month 15

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    End point title
    		 Change in HbA1c from baseline to month 15 [7]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 15 Months
    Notes
    [7] - 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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    11
    15
    14
    10
    Units: HbA1c (mmol/mol)
        arithmetic mean (standard deviation)
    5.455 ( 7.751 )
    5.667 ( 15.407 )
    5.643 ( 9.951 )
    6.5 ( 10.967 )
    No statistical analyses for this end point

    Primary: Change in HbA1c from baseline to month 30

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    End point title
    		 Change in HbA1c from baseline to month 30 [8]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Month 30.
    Notes
    [8] - 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: The clinical study protocol defined statistical methods for efficacy data regarding C-peptide and immune system as well as Adverse events and other safety data as being composed of summary tables with descriptive statistics.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    10
    14
    14
    11
    Units: HbA1c (mmol/mol)
        arithmetic mean (standard deviation)
    12.4 ( 5.816 )
    13.286 ( 15.563 )
    7.286 ( 11.323 )
    10.909 ( 16.837 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were recorded by the physician at every visit throughout the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients will be assigned to receive Ibuprofen as oral suspension; 400 mg every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group B
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 1 subcutaneous injection with 20 μg Diamyd and one with placebo given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster dose (providing a total dose of 40 μg Diamyd).

    Reporting group title
    Group C
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and from Day 1 through 450 also oral drops of Vitamin D 2000 IU per day (i.e. 25 drops per day). In addition 2 subcutaneous injections with 20 μg Diamyd given at two different sites in the stomach area, each on Days 15 and 45, i.e., prime and booster doses (providing a total dose of 80μg Diamyd).

    Reporting group title
    Group D
    Reporting group description
    		 Patients will be assigned to receive placebo as oral suspension every morning from Day 1 through 90 and placebo oral drops from Day 1 through 450, and 2 subcutaneous injections with placebo (given at two different sites in the stomach area), each on Days 15 and 45

    Serious adverse events
    		 Group A Group B Group C Group D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Group A Group B Group C Group D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 16 (75.00%)
    15 / 16 (93.75%)
    16 / 16 (100.00%)
    14 / 15 (93.33%)
    Surgical and medical procedures
    Breast operation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Injection site oedema
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    1
    1
    Injection site rash
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Injection site reaction
         subjects affected / exposed
    5 / 16 (31.25%)
    4 / 16 (25.00%)
    6 / 16 (37.50%)
    6 / 15 (40.00%)
         occurrences all number
    8
    5
    7
    7
    Pyrexia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2
    2
    Injection site pain
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Injection site nodule
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    2
    1
    2
    3
    Injection site erythema
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Injection site swelling
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    0
    1
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Back injury
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Ligament sprain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    0
    2
    Juvenile myoclonic epilepsy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    1
    2
    Diarrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    2
    Coeliac disease
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Pruritus genital
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Acne
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Microalbuminuria
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Costochondritis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Viral infection
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    3
    0
    4
    Urinary tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 16 (37.50%)
    7 / 16 (43.75%)
    7 / 16 (43.75%)
    4 / 15 (26.67%)
         occurrences all number
    10
    8
    8
    4
    Tonsillitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pseudocroup
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    1
    1
    Tinea infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    1
    0
    0
    3
    Cystitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Varicella
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Borrelia infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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