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    Clinical Trial Results:
    A Trial Investigating the Pharmacokinetic Properties of NN5401 (insulin degludec/insulin aspart) in Children, Adolescents and Adults with Type 1 Diabetes

    Summary
    EudraCT number
    		 2009-016779-31
    Trial protocol
    		 DE  
    Global end of trial date
    30 Nov 2010

    Results information
    Results version number
    		 v1
    This version publication date
    16 Mar 2016
    First version publication date
    21 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    NN5401-1982
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01138488
    WHO universal trial number (UTN)
    		 -
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000479-PIP01-08
    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
    26 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the total exposure of SIAC (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    07 Jun 2010
    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: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Single centre in Germany

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Children
    Arm description
    		 Children (6-11) : All subjects received one single dose of (100 U/mL) insulin degludec/insulin aspart (IDegAsp) (0.5 U/kg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDegAsp
    Investigational medicinal product code
    IDegAsp
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All subjects received one single dose of IDegAsp (0.5 U/kg) administered as a subcutaneous injection into a lifted skin fold of the lower abdominal wall above the inguinal area. The administration of trial occurred at approximately 8:00 hours in the morning on a single test day.

    Arm title
    		 Adolescents
    Arm description
    		 Adolescents (12-17): All subjects received one single dose (100 U/mL) of IDegAsp (0.5 U/kg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDegAsp
    Investigational medicinal product code
    IDegAsp
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All subjects received one single dose of IDegAsp (0.5 U/kg) administered as a subcutaneous injection into a lifted skin fold of the lower abdominal wall above the inguinal area. The administration of trial occurred at approximately 8:00 hours in the morning on a single test day.

    Arm title
    		 Adults
    Arm description
    		 Adults (18-65): All subjects received one single dose (100 U/mL) of IDegAsp (0.5 U/kg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDegAsp
    Investigational medicinal product code
    IDegAsp
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    All subjects received one single dose of IDegAsp (0.5 U/kg) administered as a subcutaneous injection into a lifted skin fold of the lower abdominal wall above the inguinal area. The administration of trial occurred at approximately 8:00 hours in the morning on a single test day.

    Number of subjects in period 1
    		Children Adolescents Adults
    Started
    12
    13
    13
    Completed
    12
    13
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Children
    Reporting group description
    		 Children (6-11) : All subjects received one single dose of (100 U/mL) insulin degludec/insulin aspart (IDegAsp) (0.5 U/kg)

    Reporting group title
    Adolescents
    Reporting group description
    		 Adolescents (12-17): All subjects received one single dose (100 U/mL) of IDegAsp (0.5 U/kg)

    Reporting group title
    Adults
    Reporting group description
    		 Adults (18-65): All subjects received one single dose (100 U/mL) of IDegAsp (0.5 U/kg)

    Reporting group values
    		 Children Adolescents Adults Total
    Number of subjects
    		 12 13 13 38
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 12 0 0 12
        Adolescents (12-17 years)
    		 0 13 0 13
        Adults (18-64 years)
    		 0 0 13 13
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 5 4 15
        Male
    		 6 8 9 23
    Mean duration of diabetes
    Mean duration of diabetes
    Units: Years
        arithmetic mean (standard deviation)
    		 5.8 ± 3 5.6 ± 3.2 11.3 ± 6.2 -
    HbA1c
    Mean HbA1c%
    Units: Percentage
        arithmetic mean (standard deviation)
    		 7.7 ± 1 7.6 ± 0.9 7.7 ± 0.9 -

    End points

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    End points reporting groups
    Reporting group title
    Children
    Reporting group description
    		 Children (6-11) : All subjects received one single dose of (100 U/mL) insulin degludec/insulin aspart (IDegAsp) (0.5 U/kg)

    Reporting group title
    Adolescents
    Reporting group description
    		 Adolescents (12-17): All subjects received one single dose (100 U/mL) of IDegAsp (0.5 U/kg)

    Reporting group title
    Adults
    Reporting group description
    		 Adults (18-65): All subjects received one single dose (100 U/mL) of IDegAsp (0.5 U/kg)

    Primary: AUCI454, 0-∞,SD, area under the serum insulin 454 (insulin degludec) concentration-time curve from 0 to infinity after single dose

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    End point title
    		 AUCI454, 0-∞,SD, area under the serum insulin 454 (insulin degludec) concentration-time curve from 0 to infinity after single dose
    End point description
    End point type
    Primary
    End point timeframe
    0 to infinity after single dose
    End point values
    		 Children Adolescents Adults
    Number of subjects analysed
    11
    13
    13
    Units: pmol*h/L (CV%)
        geometric mean (geometric coefficient of variation)
    121569 ± 69
    104895 ± 36
    85367 ± 24
    Statistical analysis title
    		 Mean ratio and CI
    Comparison groups
    Children v Adults
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Mean ratio
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 2.16
    Notes
    [1] - Mean ratio was calculated for Children/Adults
    Statistical analysis title
    		 Mean ratios and CI
    Comparison groups
    Adolescents v Adults
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Mean ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.58
    Notes
    [2] - Mean ratio was calculated for Adolescents/Adults

    Primary: AUCIAsp,0-12h,SD, area under the serum insulin aspart concentration-time curve from 0 to 12 hours after a single dose

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    End point title
    		 AUCIAsp,0-12h,SD, area under the serum insulin aspart concentration-time curve from 0 to 12 hours after a single dose
    End point description
    End point type
    Primary
    End point timeframe
    0 to 12 hours after single dose
    End point values
    		 Children Adolescents Adults
    Number of subjects analysed
    11
    13
    13
    Units: pmol*h/L (CV%)
        geometric mean (geometric coefficient of variation)
    1507 ± 66
    1013 ± 49
    892 ± 53
    Statistical analysis title
    		 AUCIAsp,0-12h,
    Statistical analysis description
    AUCIAsp,0-12h,SD, area under the serum insulin aspart concentration-time curve from 0 to 12 hours after a single dose
    Comparison groups
    Children v Adults
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean ratio
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 2.8
    Statistical analysis title
    		 AUCIAsp,0-12h,
    Statistical analysis description
    AUCIAsp,0-12h,SD, area under the serum insulin aspart concentration-time curve from 0 to 12 hours after a single dose
    Comparison groups
    Adolescents v Adults
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean ratio
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.69

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Onset after first trial product administration and no later than 7 days after the last trial product administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Children
    Reporting group description
    		 -

    Reporting group title
    Adolescents
    Reporting group description
    		 -

    Reporting group title
    Adults
    Reporting group description
    		 -

    Serious adverse events
    		 Children Adolescents Adults
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Children Adolescents Adults
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
    1 / 13 (7.69%)
    4 / 13 (30.77%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    0
    1
    2
    Orthostatic intolerance
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Catheter site related reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Injection site haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    0
    1
    2
    Anal abscess
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Aug 2010
    • The BMI ranges for children were set too narrowly so that subjects with normal BMI could have been excluded from the trial. Thus, in order to ensure that children and adolescents with normal BMIs were included in the trial, BMI ranges were updated to be in accordance with the German guidelines of Association of obesity in childhood and adolescence. • The allowed minimum haemoglobin value for children and adolescents were set according to haemoglobin reference values for adults (minus approximately 10 percent). In order to follow local reference ranges of haemoglobin, values were adjusted to correspond to age specific reference ranges (minus 10 percent) in order to ensure that children and adolescents with normal haemoglobin levels were not excluded from the trial. • In addition other minor corrections and changes were included in the amendment.

    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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