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    Clinical Trial Results:
    A trial investigating the pharmacokinetic properties of FIAsp in children, adolescents and adults with type 1 diabetes.

    Summary
    EudraCT number
    		 2011-002104-32
    Trial protocol
    		 DE  
    Global end of trial date
    24 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Mar 2016
    First version publication date
    08 Feb 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    New AE data to be uploaded

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN1218-3888
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02035371
    WHO universal trial number (UTN)
    		 U1111-1121-1469
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the total exposure of faster-acting insulin aspart (also known as FIAsp) between children, adolescents and adult subjects with type 1 diabetes.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996) and FDA 21 CFR 312.120.
    Background therapy
    		 Not applicable.
    Evidence for comparator
    		 Not Applicable
    Actual start date of recruitment
    13 Jan 2014
    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
    Germany: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    12
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was conducted at one site in Germany (single centre study).

    Pre-assignment
    Screening details
    		 Not applicable.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The trial was randomised, single-centre, double-blind, single-dose, two-period cross-over trial.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Faster-acting insulin aspart first, then NovoRapid
    Arm description
    		 Subjects received faster-acting insulin aspart followed by NovoRapid.
    Arm type
    		 crossover assignment

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Arm title
    		 NovoRapid first, then faster-acting insulin aspart
    Arm description
    		 Subjects received NovoRapid first, followed by faster-acting insulin aspart.
    Arm type
    		 crossover assignment

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial product dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Number of subjects in period 1
    		Faster-acting insulin aspart first, then NovoRapid NovoRapid first, then faster-acting insulin aspart
    Started
    21
    19
    Completed
    19
    19
    Not completed
    2
    0
         Difficulty in blood sampling in rescheduled visit
    1
    -
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Period 2- completers
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This was randomised, single- centre, double- blind ,single dose ,two- period cross over trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NovoRapid first, then faster-acting insulin aspart
    Arm description
    		 Subjects received NovoRapid first followed by faster-acting insulin aspart.
    Arm type
    		 crossover assignment

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Arm title
    		 Faster-acting insulin aspart first, then NovoRapid
    Arm description
    		 Subjects received faster- acting insulin aspart first, followed by NovoRapid.
    Arm type
    		 crossover assignment

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level were 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Number of subjects in period 2
    		NovoRapid first, then faster-acting insulin aspart Faster-acting insulin aspart first, then NovoRapid
    Started
    19
    19
    Completed
    19
    19
    Period 3
    Period 3 title
    Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This trial was randomised, double-blind, single centre, single dose, two-period , cross over study.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Faster-acting insulin aspart: Children (6-11 years)
    Arm description
    		 Subjects received faster-acting Insulin aspart followed by NovoRapid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Arm title
    		 Faster-acting insulin aspart: Adolescents (12-17 years)
    Arm description
    		 Subjects received faster-acting Insulin aspart followed by NovoRapid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Arm title
    		 Faster-acting insulin aspart: Adults (18-64 years)
    Arm description
    		 Subjects received faster-acting Insulin aspart followed by NovoRapid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faster-acting insulin aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial products dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Arm title
    		 NovoRapid: Children (6-11years)
    Arm description
    		 Subjects received NovoRapid followed by faster-acting Insulin aspart.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial product dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Arm title
    		 NovoRapid: Adolescents (12-17 years)
    Arm description
    		 Subjects received NovoRapid followed by faster-acting Insulin aspart.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial product, the dose level was 0.2 U/kg body weight. The trial product were administered subcutaneously in the abdomen.

    Arm title
    		 NovoRapid: Adults (18-64 years)
    Arm description
    		 Subjects received NovoRapid followed by faster-acting insulin aspart.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    NovoRapid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Trial product dose level was 0.2 U/kg body weight. The trial products were administered subcutaneously in the abdomen.

    Number of subjects in period 3
    		Faster-acting insulin aspart: Children (6-11 years) Faster-acting insulin aspart: Adolescents (12-17 years) Faster-acting insulin aspart: Adults (18-64 years) NovoRapid: Children (6-11years) NovoRapid: Adolescents (12-17 years) NovoRapid: Adults (18-64 years)
    Started
    12
    13
    15
    12
    13
    13
    Completed
    12
    13
    13
    12
    13
    13
    Not completed
    0
    0
    2
    0
    0
    0
         Difficulty in blood sampling in rescheduled visit
    -
    -
    1
    -
    -
    -
         Protocol deviation
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 Each subject were randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-22 days.

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 40 40
    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)
    		 12 12
        Adolescents (12-17 years)
    		 13 13
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Faster-acting insulin aspart first, then NovoRapid
    Reporting group description
    		 Subjects received faster-acting insulin aspart followed by NovoRapid.

    Reporting group title
    NovoRapid first, then faster-acting insulin aspart
    Reporting group description
    		 Subjects received NovoRapid first, followed by faster-acting insulin aspart.
    Reporting group title
    NovoRapid first, then faster-acting insulin aspart
    Reporting group description
    		 Subjects received NovoRapid first followed by faster-acting insulin aspart.

    Reporting group title
    Faster-acting insulin aspart first, then NovoRapid
    Reporting group description
    		 Subjects received faster- acting insulin aspart first, followed by NovoRapid.
    Reporting group title
    Faster-acting insulin aspart: Children (6-11 years)
    Reporting group description
    		 Subjects received faster-acting Insulin aspart followed by NovoRapid.

    Reporting group title
    Faster-acting insulin aspart: Adolescents (12-17 years)
    Reporting group description
    		 Subjects received faster-acting Insulin aspart followed by NovoRapid.

    Reporting group title
    Faster-acting insulin aspart: Adults (18-64 years)
    Reporting group description
    		 Subjects received faster-acting Insulin aspart followed by NovoRapid.

    Reporting group title
    NovoRapid: Children (6-11years)
    Reporting group description
    		 Subjects received NovoRapid followed by faster-acting Insulin aspart.

    Reporting group title
    NovoRapid: Adolescents (12-17 years)
    Reporting group description
    		 Subjects received NovoRapid followed by faster-acting Insulin aspart.

    Reporting group title
    NovoRapid: Adults (18-64 years)
    Reporting group description
    		 Subjects received NovoRapid followed by faster-acting insulin aspart.

    Primary: AUCIAsp, 0–12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours

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    End point title
    		 AUCIAsp, 0–12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
    End point description
    Area under the serum insulin aspart concentration-time curve.
    End point type
    Primary
    End point timeframe
    0-12 hours
    End point values
    		 Faster-acting insulin aspart: Children (6-11 years) Faster-acting insulin aspart: Adolescents (12-17 years) Faster-acting insulin aspart: Adults (18-64 years) NovoRapid: Children (6-11years) NovoRapid: Adolescents (12-17 years) NovoRapid: Adults (18-64 years)
    Number of subjects analysed
    12
    13
    15
    12
    13
    13
    Units: pmol h/L
        median (full range (min-max))
    380.45 (308.26 to 562.02)
    504.66 (411.56 to 717.09)
    687.68 (465.16 to 913.32)
    455.59 (250.63 to 539.3)
    510.56 (371.26 to 821.21)
    686.89 (500.51 to 861.14)
    Statistical analysis title
    		 AUC (0-12h) Faster Aspart : Children/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by-treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    Faster-acting insulin aspart: Adults (18-64 years) v Faster-acting insulin aspart: Children (6-11 years)
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 0.69
    Notes
    [1] - Exploratory comparison
    Statistical analysis title
    		 AUC (0-12h) Faster Aspart : Adolescents/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by-treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    Faster-acting insulin aspart: Adolescents (12-17 years) v Faster-acting insulin aspart: Adults (18-64 years)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.9
    Notes
    [2] - Exploratory comparison
    Statistical analysis title
    		 AUC (0-12h ) NovoRapid: Children/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    NovoRapid: Children (6-11years) v NovoRapid: Adults (18-64 years)
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.7
    Notes
    [3] - Exploratory comparison
    Statistical analysis title
    		 AUC (0-12h) NovoRapid : Adolescents/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    NovoRapid: Adolescents (12-17 years) v NovoRapid: Adults (18-64 years)
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.87
    Notes
    [4] - Exploratory comparison

    Secondary: Cmax,IAsp,maximum observed serum insulin aspart concentration

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    End point title
    		 Cmax,IAsp,maximum observed serum insulin aspart concentration
    End point description
    Maximum observed serum insulin aspart concentration.
    End point type
    Secondary
    End point timeframe
    From 0-12hours
    End point values
    		 Faster-acting insulin aspart: Children (6-11 years) Faster-acting insulin aspart: Adolescents (12-17 years) Faster-acting insulin aspart: Adults (18-64 years) NovoRapid: Children (6-11years) NovoRapid: Adolescents (12-17 years) NovoRapid: Adults (18-64 years)
    Number of subjects analysed
    12
    13
    15
    12
    13
    13
    Units: pmol/L
        median (full range (min-max))
    255.1 (160.8 to 380.1)
    276.8 (165 to 458.2)
    257.7 (149.1 to 502.3)
    271.65 (113 to 412.9)
    261.3 (155.4 to 400.1)
    267.3 (154.2 to 430.3)
    Statistical analysis title
    		 Cmax Faster aspart : Children/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by-treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    Faster-acting insulin aspart: Children (6-11 years) v Faster-acting insulin aspart: Adults (18-64 years)
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.17
    Notes
    [5] - Exploratory comparison
    Statistical analysis title
    		 Cmax Faster aspart : Adolescents/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    Faster-acting insulin aspart: Adolescents (12-17 years) v Faster-acting insulin aspart: Adults (18-64 years)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.26
    Notes
    [6] - Exploratory comparison
    Statistical analysis title
    		 Cmax NovoRapid : Children/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by-treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    NovoRapid: Children (6-11years) v NovoRapid: Adults (18-64 years)
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.18
    Notes
    [7] - Exploratory comparison
    Statistical analysis title
    		 Cmax NovoRapid : Adolescents/Adults
    Statistical analysis description
    The endpoint was log-transformed and then analysed using a linear mixed model with age-group, treatment, age-group-by-treatment interaction and period as fixed effects and subject as a random effect. The variance of the random effect and the residual variance depend on age.
    Comparison groups
    NovoRapid: Adolescents (12-17 years) v NovoRapid: Adults (18-64 years)
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric-mean ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.17
    Notes
    [8] - Exploratory comparison

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events were collected at visit 2 (Day 1 and Day 2),visit 3 (Day 1, Day 2, 3-22 days after V2, D2), and Follow-up visit (7-22 days after V3, D2).
    Adverse event reporting additional description
    Safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Subjects in the safety analysis set contributed to the evaluation "as treated".
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Faster-acting insulin aspart: Children (6-11years)
    Reporting group description
    		 Subjects received faster-acting insulin aspart followed by NovoRapid.

    Reporting group title
    Faster-acting insulin aspart: Adolescents (12-17 years)
    Reporting group description
    		 Subjects received faster-acting insulin aspart followed by NovoRapid.

    Reporting group title
    Faster-acting insulin aspart: Adults (18-64 years)
    Reporting group description
    		 Subjects received faster-acting insulin aspart followed by NovoRapid.

    Reporting group title
    NovoRapid: Children (6-11years)
    Reporting group description
    		 Subjects received NovoRapid followed by faster-acting insulin aspart.

    Reporting group title
    NovoRapid: Adolescents (12-17 years)
    Reporting group description
    		 Subjects received NovoRapid followed by faster-acting insulin aspart.

    Reporting group title
    NovoRapid: Adults (18-64 years)
    Reporting group description
    		 Subjects received NovoRapid followed by faster-acting insulin aspart.

    Serious adverse events
    		 Faster-acting insulin aspart: Children (6-11years) Faster-acting insulin aspart: Adolescents (12-17 years) Faster-acting insulin aspart: Adults (18-64 years) NovoRapid: Children (6-11years) NovoRapid: Adolescents (12-17 years) NovoRapid: Adults (18-64 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Faster-acting insulin aspart: Children (6-11years) Faster-acting insulin aspart: Adolescents (12-17 years) Faster-acting insulin aspart: Adults (18-64 years) NovoRapid: Children (6-11years) NovoRapid: Adolescents (12-17 years) NovoRapid: Adults (18-64 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    3 / 15 (20.00%)
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    2 / 13 (15.38%)
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Catheter site haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Apr 2014
    One substantial amendment was made to the protocol, and this occurred after first patient first visit. The changes introduced in the amendment were 1.Extension of the maximum time allowed between visits in order to provide more flexibility in the scheduling of patients to attend visits From 3−21 days to 3−22 days between the screening visit (V1) and the first dosing visit (V2). From 3−12 days to 3−22 days between dosing visits (V2 and V3). From 7−21 days to 7−22 days between the second dosing visit (V3) and the follow-up visit (V4) 2. The timing of the fundoscopy assessment at the screening visit (V1) was extended to allow assessment up until the day before the first dosing visit (V2), day 1 to provide more flexibility in the screening of subjects. 3. Addition of dose to the information collected for concomitant medication, in order to be consistent with the concomitant medication form.

    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.
    Not applicable
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