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    Clinical Trial Results:
    - PRE-POINT-EARLY STUDY - Pilot study using oral insulin at early age for immune efficacy in primary prevention of type 1 diabetes

    Summary
    EudraCT number
    		 2014-005287-15
    Trial protocol
    		 DE  
    Global end of trial date
    21 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2020
    First version publication date
    22 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    808040017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02547519
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München; Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, Munich, Germany, 81675
    Public contact
    Prof. Dr. Anette-G. Ziegler, Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, +49 8931872896, anette-g.ziegler@helmholtz-muenchen.de
    Scientific contact
    Prof. Dr. Anette-G. Ziegler, Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, +49 8931872896, anette-g.ziegler@helmholtz-muenchen.de
    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
    21 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether daily administration of up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to insulin with features of immune regulation.
    Protection of trial subjects
    Local anesthetics (EMLA) to reduce pain during blood draws
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Dec 2015
    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
    Germany: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    38
    Children (2-11 years)
    6
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Children from age 6 months to 2 years who have at least one first degree relative with type 1 diabetes diagnosed before age 40 years.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oral Insulin
    Arm description
    		 Human Insulin (7.5 mg, 22.5 mg, 67.5 mg per day) is given orally daily together with food for the duration of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral Insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Content of one capsule (7.5 mg, 22.5 mg or 67.5 mg Human insulin) is given orally daily together with food for the duration of the study.

    Arm title
    		 Placebo
    Arm description
    		 Content of one capsule is given orally daily together with food for the duration of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo is given orally daily together with food for the duration of the study.

    Number of subjects in period 1
    		Oral Insulin Placebo
    Started
    22
    22
    Completed
    21
    20
    Not completed
    1
    2
         Adverse event, non-fatal
    -
    1
         Dropped out due to illness of the sibling twin
    1
    -
         due to social/familiar problems
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oral Insulin
    Reporting group description
    		 Human Insulin (7.5 mg, 22.5 mg, 67.5 mg per day) is given orally daily together with food for the duration of the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Content of one capsule is given orally daily together with food for the duration of the study.

    Reporting group values
    		 Oral Insulin Placebo Total
    Number of subjects
    		 22 22 44
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 20 18 38
        Children (2-11 years)
    		 2 4 6
    Gender categorical
    Units: Subjects
        female
    		 7 10 17
        male
    		 15 12 27
    Subject analysis sets

    Subject analysis set title
    INS AA genotype oral insulin
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Frequency of immune responses was compared between treatment groups in subjects with susceptible INS AA genotype.

    Subject analysis set title
    INS AA genotype placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Frequency of immune responses was compared between treatment groups in subjects with susceptible INS AA genotype.

    Subject analysis set title
    Safety / Insulin
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    There was no difference between Placebo and Insulin group in: - blood glucose, - Insulin, - C-Peptide values, - the Insulin / C-Peptide ratio or - the areas under the concentration time curve for glucose, Insulin or C-Peptide.

    Subject analysis set title
    Safety / Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    There was no difference between Placebo and Insulin group in: - blood glucose, - Insulin, - C-Peptide values, - the Insulin / C-Peptide ratio or - the areas under the concentration time curve for glucose, Insulin or C-Peptide.

    Subject analysis sets values
    		 INS AA genotype oral insulin INS AA genotype placebo Safety / Insulin Safety / Placebo
    Number of subjects
    11
    11
    22
    21
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    10
    9
        Children (2-11 years)
    1
    2
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        female
    2
    6
        male
    9
    5

    End points

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    End points reporting groups
    Reporting group title
    Oral Insulin
    Reporting group description
    		 Human Insulin (7.5 mg, 22.5 mg, 67.5 mg per day) is given orally daily together with food for the duration of the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Content of one capsule is given orally daily together with food for the duration of the study.

    Subject analysis set title
    INS AA genotype oral insulin
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Frequency of immune responses was compared between treatment groups in subjects with susceptible INS AA genotype.

    Subject analysis set title
    INS AA genotype placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Frequency of immune responses was compared between treatment groups in subjects with susceptible INS AA genotype.

    Subject analysis set title
    Safety / Insulin
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    There was no difference between Placebo and Insulin group in: - blood glucose, - Insulin, - C-Peptide values, - the Insulin / C-Peptide ratio or - the areas under the concentration time curve for glucose, Insulin or C-Peptide.

    Subject analysis set title
    Safety / Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    There was no difference between Placebo and Insulin group in: - blood glucose, - Insulin, - C-Peptide values, - the Insulin / C-Peptide ratio or - the areas under the concentration time curve for glucose, Insulin or C-Peptide.

    Primary: Immune response

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    End point title
    		 Immune response
    End point description
    Immune response was defined as an increase in serum IgG antibodies to insulin, salivary IgA antibodies to insulin, or serum IAA and a CD4+ T cell response was defined as a stimulation index (SI) above 3 that was more than 2-fold increased over baseline.
    End point type
    Primary
    End point timeframe
    12 months (from baseline until end of treatment)
    End point values
    		 Oral Insulin Placebo INS AA genotype oral insulin INS AA genotype placebo
    Number of subjects analysed
    22
    21
    11
    11
    Units: subjects
    12
    14
    9
    7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Oral Insulin
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54 [1]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - The difference in the frequency of observed positive outcomes between the 2 treatment arms was not significant.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    INS AA genotype placebo v INS AA genotype oral insulin
    Number of subjects included in analysis
    22
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.64
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Gene expression of insulin responsive CD4+ T-Cells at 12 months

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    End point title
    		 Gene expression of insulin responsive CD4+ T-Cells at 12 months
    End point description
    Gene expression values of insulin responsive CD4+ T-cells was measured as FOXP3 Treg/IFNg cell ratio
    End point type
    Secondary
    End point timeframe
    at 12 months
    End point values
    		 Oral Insulin Placebo
    Number of subjects analysed
    1
    4
    Units: --
        median (inter-quartile range (Q1-Q3))
    1.00 (1.00 to 1.00)
    6.44 (4.61 to 14.00)
    No statistical analyses for this end point

    Other pre-specified: Antibody Response to insulin

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    End point title
    		 Antibody Response to insulin
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 months (Baseline to End of treatment)
    End point values
    		 Oral Insulin Placebo INS AA genotype oral insulin INS AA genotype placebo
    Number of subjects analysed
    22
    21
    11
    11
    Units: subjects
    9
    7
    8
    2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Oral Insulin v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    INS AA genotype oral insulin v INS AA genotype placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03 [2]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [2] - The difference in observed positive outcomes between the two treatment arms was significant.

    Other pre-specified: CD4+ T-Cell Response to insulin

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    End point title
    		 CD4+ T-Cell Response to insulin
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 months ( Baseline until End of Treatment)
    End point values
    		 Oral Insulin Placebo
    Number of subjects analysed
    22
    21
    Units: subjects
    4
    8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Oral Insulin v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Fisher exact
    Confidence interval

    Other pre-specified: LOG2 CD4+ T-Cell Values at 9 months

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    End point title
    		 LOG2 CD4+ T-Cell Values at 9 months
    End point description
    End point type
    Other pre-specified
    End point timeframe
    at 9 months
    End point values
    		 Oral Insulin Placebo
    Number of subjects analysed
    19
    21
    Units: SI (stimulation index)
        median (inter-quartile range (Q1-Q3))
    0.54 (-0.09 to 0.99)
    0.55 (0.20 to 0.93)
    No statistical analyses for this end point

    Other pre-specified: LOG2 CD4+ T-Cell Values at 12 months

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    End point title
    		 LOG2 CD4+ T-Cell Values at 12 months
    End point description
    End point type
    Other pre-specified
    End point timeframe
    at 12 months
    End point values
    		 Oral Insulin Placebo
    Number of subjects analysed
    18
    18
    Units: SI (stimulation index)
        median (inter-quartile range (Q1-Q3))
    -0.04 (-0.47 to 0.21)
    0.50 (-0.07 to 0.87)
    No statistical analyses for this end point

    Other pre-specified: IGE Analysis Placebo versus Verum at 12 month

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    End point title
    		 IGE Analysis Placebo versus Verum at 12 month
    End point description
    End point type
    Other pre-specified
    End point timeframe
    At 12 month visit
    End point values
    		 Safety / Insulin Safety / Placebo
    Number of subjects analysed
    22
    21
    Units: Subjects
    17
    17
    Statistical analysis title
    		 Analyse 1
    Comparison groups
    Safety / Insulin v Safety / Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.174
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Other pre-specified: Safety

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    End point title
    		 Safety
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Complete study duration
    End point values
    		 Safety / Insulin Safety / Placebo
    Number of subjects analysed
    22
    21
    Units: Subjects
    8
    1
    Statistical analysis title
    		 Analysis 1 / Skin and subcutaneus tissue disorders
    Comparison groups
    Safety / Insulin v Safety / Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded throughout the study; documentation and assessment of AEs and SAEs occurred during 3 monthly visits.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Reference placebo, filled with microcrystalline cellulose as filling substance, orally, once daily for the duration of the study

    Reporting group title
    Verum
    Reporting group description
    		 Human Insulin (7.5mg, 22.5mg, 67.5mg), orally, once daily for the duration of the study

    Serious adverse events
    		 Placebo Verum
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 22 (13.64%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    burns second degree
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stair fall
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Invagination
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia right basal lobe
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Pneumonia / Bronchitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis with dehydration
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Verum
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 21 (90.48%)
    21 / 22 (95.45%)
    Investigations
    Temperature elevation
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Falling down
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Fibula fracture
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Wasp sting
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Hydrozele
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Inguinal hernia repair
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Routine vaccination
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Orchiopexy
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Lymphadenitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    General malaise
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    3
    Fever
         subjects affected / exposed
    11 / 21 (52.38%)
    14 / 22 (63.64%)
         occurrences all number
    18
    26
    Fatigue
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Immune system disorders
    Peanut allergy
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
    8 / 22 (36.36%)
         occurrences all number
    2
    10
    Invagination of intestine
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Threw up
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Stomatitis/Stomatitis aphtosa
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Teething/Teething pain
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 22 (9.09%)
         occurrences all number
    3
    5
    Vomiting
         subjects affected / exposed
    3 / 21 (14.29%)
    4 / 22 (18.18%)
         occurrences all number
    3
    6
    Tooth pain
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 22 (9.09%)
         occurrences all number
    3
    6
    Respiratory, thoracic and mediastinal disorders
    Cough/Coughing
         subjects affected / exposed
    4 / 21 (19.05%)
    6 / 22 (27.27%)
         occurrences all number
    6
    14
    Runny nose
         subjects affected / exposed
    1 / 21 (4.76%)
    5 / 22 (22.73%)
         occurrences all number
    1
    5
    Sore throat
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Reactive airways disease
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Diaper rash
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    4
    Eczema
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    Erythema/Erythema facial
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    Exanthema
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    Infections and infestations
    Acute gastroenteritis/Gastroenteritis/Gastroenteritis and fungal infection
         subjects affected / exposed
    7 / 21 (33.33%)
    12 / 22 (54.55%)
         occurrences all number
    7
    20
    Bronchitis/Bronchitis viral
         subjects affected / exposed
    6 / 21 (28.57%)
    6 / 22 (27.27%)
         occurrences all number
    7
    7
    Common cold
         subjects affected / exposed
    13 / 21 (61.90%)
    10 / 22 (45.45%)
         occurrences all number
    25
    28
    Conjunctivitis
         subjects affected / exposed
    5 / 21 (23.81%)
    5 / 22 (22.73%)
         occurrences all number
    5
    6
    Gingivitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    hand-mouth-feet disease
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 22 (9.09%)
         occurrences all number
    3
    2
    croup
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Febrile cold (excl flu like illness)
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    Impetigo
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Otitis / Otitis media
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 22 (0.00%)
         occurrences all number
    5
    0
    Pneumonia/Obstructive pneumonia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 22 (18.18%)
         occurrences all number
    11
    4
    Viral infection
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Oral infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    3
    Herpes simplex
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    no appetite
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    dehydration
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Aug 2015
    Investigator's Brochure (IB): Chapter 6 of the IB has been revised and updated. Furthermore, the results, especially the safety data, of the completed Pre-POINT study were described in more detail. Study protocol: (1) The benefit-risk analysis in chapter 2.6.1 and 2.6.2 was described in more detail with regard to the current results of the Pre-POINT study and other studies with oral insulin for the prevention of type 1 diabetes (DPT-1 study and TN07-TrialNet Oral Insulin Study) and analyzed with regard to the benefit-risk ratio on this basis. (2) The dosage information from international units has been added in Chapters 2.8 and 6.1.1. (3) It is also included in the study protocol that the study physician clearly indicates the risk of approximately 10% of patients suffering from type 1 diabetes during the consenting process (Chapter 7.2). Patient information and patient informed consent: The information on current study results was revised and presented in more detail.

    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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