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    Clinical Trial Results:
    A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency

    Summary
    EudraCT number
    2013-000013-20
    Trial protocol
    SI   BE   AT   SE   ES   FR  
    Global end of trial date
    04 Nov 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    15 Apr 2016
    First version publication date
    16 May 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    AE data to be updated

    Trial information

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    Trial identification
    Sponsor protocol code
    NN8640-4042
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01973244
    WHO universal trial number (UTN)
    U1111-1138-2206
    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
    19 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate safety and tolerability of a single subcutaneous (s.c.) dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with growth hormone deficiency (GHD)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013), ICH Good Clinical Practice (GCP) (1996) and FDA 21 CFR 312.120.
    Background therapy
    Not applicable.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    16 Dec 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
    Slovenia: 6
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Macedonia, the former Yugoslav Republic of: 4
    Worldwide total number of subjects
    32
    EEA total number of subjects
    23
    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)
    32
    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
    The trial was conducted at 14 sites in 8 countries.

    Pre-assignment
    Screening details
    Not applicable.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    0.02 mg/Kg - NNC0195-0092
    Arm description
    0.02 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0195-0092
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.02 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Arm title
    0.04 mg/Kg - NNC0195-0092
    Arm description
    0.04 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0195-0092
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.04 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Arm title
    0.08 mg/Kg - NNC0195-0092
    Arm description
    0.08 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0195-0092
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.08 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Arm title
    0.16 mg/Kg - NNC0195-0092
    Arm description
    0.16 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.
    Arm type
    Experimental

    Investigational medicinal product name
    NNC0195-0092
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.16 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Arm title
    0.03 mg/Kg - Norditropin® SimpleXx®
    Arm description
    0.03 mg/Kg, once daily dose of Norditropin® SimpleXx® was administered to subjects subcutaneously, for 7 days.
    Arm type
    Active comparator

    Investigational medicinal product name
    Norditropin® SimpleXx®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.03 mg/Kg, once daily dose of Norditropin® SimpleXx® was administered to subjects subcutaneously, for 7 days.

    Number of subjects in period 1
    0.02 mg/Kg - NNC0195-0092 0.04 mg/Kg - NNC0195-0092 0.08 mg/Kg - NNC0195-0092 0.16 mg/Kg - NNC0195-0092 0.03 mg/Kg - Norditropin® SimpleXx®
    Started
    6
    6
    6
    6
    8
    Completed
    6
    6
    6
    6
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    0.02 mg/Kg - NNC0195-0092
    Reporting group description
    0.02 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.04 mg/Kg - NNC0195-0092
    Reporting group description
    0.04 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.08 mg/Kg - NNC0195-0092
    Reporting group description
    0.08 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.16 mg/Kg - NNC0195-0092
    Reporting group description
    0.16 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.03 mg/Kg - Norditropin® SimpleXx®
    Reporting group description
    0.03 mg/Kg, once daily dose of Norditropin® SimpleXx® was administered to subjects subcutaneously, for 7 days.

    Reporting group values
    0.02 mg/Kg - NNC0195-0092 0.04 mg/Kg - NNC0195-0092 0.08 mg/Kg - NNC0195-0092 0.16 mg/Kg - NNC0195-0092 0.03 mg/Kg - Norditropin® SimpleXx® Total
    Number of subjects
    6 6 6 6 8 32
    Age categorical
    Units: Subjects
        Children (2-11 years)
    6 6 6 6 8 32
    Gender categorical
    Units: Subjects
        Female
    2 5 1 1 0 9
        Male
    4 1 5 5 8 23
    Height
    Units: meter
        arithmetic mean (standard deviation)
    1.2 ± 0.1 1.3 ± 0.1 1.3 ± 0.1 1.3 ± 0.1 1.3 ± 0.2 -
    Body weight
    Units: Kg
        arithmetic mean (standard deviation)
    23.1 ± 8.9 27.8 ± 5.6 27.1 ± 7.4 26.7 ± 6.9 26.1 ± 7.5 -
    Body mass index (BMI)
    Units: Kg/m2
        arithmetic mean (standard deviation)
    15.8 ± 2.2 17.4 ± 3.4 16.6 ± 1.9 15.6 ± 1.9 16.2 ± 1.4 -

    End points

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    End points reporting groups
    Reporting group title
    0.02 mg/Kg - NNC0195-0092
    Reporting group description
    0.02 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.04 mg/Kg - NNC0195-0092
    Reporting group description
    0.04 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.08 mg/Kg - NNC0195-0092
    Reporting group description
    0.08 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.16 mg/Kg - NNC0195-0092
    Reporting group description
    0.16 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.03 mg/Kg - Norditropin® SimpleXx®
    Reporting group description
    0.03 mg/Kg, once daily dose of Norditropin® SimpleXx® was administered to subjects subcutaneously, for 7 days.

    Primary: Incidence of adverse events (AEs)

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    End point title
    Incidence of adverse events (AEs) [1]
    End point description
    Incidence of adverse events (AEs) from first administration of trial product and up until day 35 (final visit).
    End point type
    Primary
    End point timeframe
    From first administration of trial product and up until day 35 (final visit).
    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 primary endpoint investigates safety and is analysed using descriptive statistics, and thus no statistical analysis is performed.
    End point values
    0.02 mg/Kg - NNC0195-0092 0.04 mg/Kg - NNC0195-0092 0.08 mg/Kg - NNC0195-0092 0.16 mg/Kg - NNC0195-0092 0.03 mg/Kg - Norditropin® SimpleXx®
    Number of subjects analysed
    6 [2]
    6 [3]
    6 [4]
    6 [5]
    8 [6]
    Units: Number of adverse events
    3
    9
    3
    4
    2
    Notes
    [2] - 3 events were reported in 2 subjects
    [3] - 9 events were reported in 4 subjects
    [4] - 3 events were reported in 2 subjects
    [5] - 4 events were reported in 3 subjects
    [6] - 2 events were reported in 1 subject
    No statistical analyses for this end point

    Secondary: The area under the insulin-like growth factor I (IGF-I) concentration-time curve (AUC 0-168h)

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    End point title
    The area under the insulin-like growth factor I (IGF-I) concentration-time curve (AUC 0-168h)
    End point description
    The area under the insulin-like growth factor I (IGF-I) concentration-time curve (AUC 0-168h)
    End point type
    Secondary
    End point timeframe
    From 0 to 168 hours after dosing.
    End point values
    0.02 mg/Kg - NNC0195-0092 0.04 mg/Kg - NNC0195-0092 0.08 mg/Kg - NNC0195-0092 0.16 mg/Kg - NNC0195-0092 0.03 mg/Kg - Norditropin® SimpleXx®
    Number of subjects analysed
    6
    6
    6
    6
    8
    Units: ng*h/mL
        geometric mean (geometric coefficient of variation)
    16153 ± 57
    24199 ± 86.6
    42218 ± 28.1
    34350 ± 13.5
    34989 ± 59.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first trial-related activity after the subject has signed the informed consent until the end of the post-treatment follow-up period (up until day 35).
    Adverse event reporting additional description
    An adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    0.04 mg/Kg - NNC0195-0092
    Reporting group description
    0.04 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.08 mg/Kg - NNC0195-0092
    Reporting group description
    0.08 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Reporting group title
    0.16 mg/Kg - NNC0195-0092
    Reporting group description
    0.16 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously..

    Reporting group title
    0.03 mg/Kg - Norditropin® SimpleXx®
    Reporting group description
    0.03 mg/Kg, once daily dose of Norditropin® SimpleXx® was administered to subjects subcutaneously, for 7 days.

    Reporting group title
    0.02 mg/Kg - NNC0195-0092
    Reporting group description
    0.02 mg/Kg, single dose of NNC0195-0092 was administered to subjects subcutaneously.

    Serious adverse events
    0.04 mg/Kg - NNC0195-0092 0.08 mg/Kg - NNC0195-0092 0.16 mg/Kg - NNC0195-0092 0.03 mg/Kg - Norditropin® SimpleXx® 0.02 mg/Kg - NNC0195-0092
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    0.04 mg/Kg - NNC0195-0092 0.08 mg/Kg - NNC0195-0092 0.16 mg/Kg - NNC0195-0092 0.03 mg/Kg - Norditropin® SimpleXx® 0.02 mg/Kg - NNC0195-0092
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    1 / 8 (12.50%)
    2 / 6 (33.33%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site swelling
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Nausea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Enterobiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Otitis media
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    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.
    Not applicable.
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