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    Clinical Trial Results:
    A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults with Type 1 Diabetes

    Summary
    EudraCT number
    		 2008-008306-43
    Trial protocol
    		 DE  
    Global end of trial date
    03 May 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Mar 2016
    First version publication date
    01 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    AE data to be added

    Trial information

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    Trial identification
    Sponsor protocol code
    NN1250-1995
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01030926
    WHO universal trial number (UTN)
    		 U1111-1112-4715
    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-000456-PIP01-08 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
    22 Dec 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the pharmacokinetic total exposure of SIBA (NN1250, IDeg) in children, adolescents and adult subjects with type 1 diabetes
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (59th WMA General Assembly, Seoul 2008. Last amended with Note of Clarification on Paragraph 29 by the WMA General Assembly, Washington 2002, and Note of Clarification on Paragraph 30 by the WMA General assembly, Tokyo 2004) and International Conference on Harmonisation (ICH) Good Clinical Practice (June 1996).
    Background therapy
    		 The following non-investigational medicinal products were used: NPH insulin: Protaphane®, Novolin® N 100 IU/mL, in 3 mL FlexPen®) Insulin aspart: NovoRapid®, NovoLog® 100 U/mL, in 3 mL FlexPen®and in 10 mL vials)
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    08 Dec 2009
    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: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    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)
    13
    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
    		 The trial was conducted at one site in Germany.

    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
    In order to maintain the blinding, a person not otherwise involved in the conduct of the trial prepared the doses according to the randomisation provided by Novo Nordisk A/S. It was ensured that the cartridge or syringe containing trial product was not revealed to the subject or to the Investigator.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IDeg in Period 1
    Arm description
    		 In Period 1, subjects were randomly assigned to receive a single dose of IDeg.
    Arm type
    		 Cross-over assignment

    Investigational medicinal product name
    IDeg
    Investigational medicinal product code
    Other name
    SIBA, NN1250, insulin degludec
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IDeg (0.4 U/kg body weight [BW]), administered as a subcutaneous (s.c.) injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IGlar in Period 1
    Arm description
    		 In Period 1, subjects were randomly assigned to receive a single dose of IGlar.
    Arm type
    		 Cross-over assignment

    Investigational medicinal product name
    IGlar
    Investigational medicinal product code
    Other name
    Insulin glargine, Lantus
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IGlar (0.4 U/kg BW), administered as a s.c. injection into a lifted skin fold on the anterior surface of the thigh.

    Number of subjects in period 1
    		IDeg in Period 1 IGlar in Period 1
    Started
    19
    20
    Exposed
    18
    20
    Completed
    18
    20
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    In order to maintain the blinding, a person not otherwise involved in the conduct of the trial prepared the doses according to the randomisation provided by Novo Nordisk A/S. It was ensured that the cartridge or syringe containing trial product was not revealed to the subject or to the Investigator.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IDeg in Period 2
    Arm description
    		 Subjects, who received IGlar in Period 1, were assigned to receive a single dose of IDeg in Period 2. There was a wash-out period of 7-21 days in between Period 1 and Period 2.
    Arm type
    		 Cross-over assignment

    Investigational medicinal product name
    IDeg
    Investigational medicinal product code
    Other name
    SIBA, NN1250, insulin degludec
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IDeg (0.4 U/kg BW), administered as a subcutaneous (s.c.) injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IGlar in Period 2
    Arm description
    		 Subjects, who received IDeg in Period 1, were assigned to receive a single dose of IGlar in Period 2. There was a wash-out period of 7-21 days in between Period 1 and Period 2.
    Arm type
    		 Cross-over assignment

    Investigational medicinal product name
    IGlar
    Investigational medicinal product code
    Other name
    Insulin glargine, Lantus
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IGlar (0.4 U/kg BW), administered as a s.c. injection into a lifted skin fold on the anterior surface of the thigh.

    Number of subjects in period 2 [1]
    		IDeg in Period 2 IGlar in Period 2
    Started
    19
    18
    Exposed
    19
    18
    Completed
    19
    18
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One subject was withdrawn after Period 1 due to difficult venous conditions (difficulties of drawing blood).
    Period 3
    Period 3 title
    Period 3 (completers)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    In order to maintain the blinding, a person not otherwise involved in the conduct of the trial prepared the doses according to the randomisation provided by Novo Nordisk A/S. It was ensured that the cartridge or syringe containing trial product was not revealed to the subject or to the Investigator.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 IDeg: Children
    Arm description
    		 Subjects (children [6-11 years]) were randomly assigned to receive a single dose of IDeg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDeg
    Investigational medicinal product code
    Other name
    SIBA, NN1250, insulin degludec
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IDeg (0.4 U/kg BW), administered as a subcutaneous (s.c.) injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IDeg: Adolescents
    Arm description
    		 Subjects (adolescents [12-17 years]) were randomly assigned to receive a single dose of IDeg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDeg
    Investigational medicinal product code
    Other name
    SIBA, NN1250, insulin degludec
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IDeg (0.4 U/kg BW), administered as a subcutaneous (s.c.) injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IDeg: Adults
    Arm description
    		 Subjects (adults [18-65 years]) were randomly assigned to receive a single dose of IDeg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDeg
    Investigational medicinal product code
    Other name
    SIBA, NN1250, insulin degludec
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IDeg (0.4 U/kg BW), administered as a subcutaneous (s.c.) injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IGlar: Children
    Arm description
    		 Subjects (children [6-11 years]) were randomly assigned to receive a single dose of IGlar.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IGlar
    Investigational medicinal product code
    Other name
    Insulin glargine, Lantus
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IGlar (0.4 U/kg BW), administered as a s.c. injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IGlar: Adolescents
    Arm description
    		 Subjects (adolescents [12-17 years]) were randomly assigned to receive a single dose of IDeg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IGlar
    Investigational medicinal product code
    Other name
    Insulin glargine, Lantus
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IGlar (0.4 U/kg BW), administered as a s.c. injection into a lifted skin fold on the anterior surface of the thigh.

    Arm title
    		 IGlar: Adults
    Arm description
    		 Subjects (adults [18-65 years]) were randomly assigned to receive a single dose of IGlar.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IGlar
    Investigational medicinal product code
    Other name
    Insulin glargine, Lantus
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of IGlar (0.4 U/kg BW), administered as a s.c. injection into a lifted skin fold on the anterior surface of the thigh.

    Number of subjects in period 3
    		IDeg: Children IDeg: Adolescents IDeg: Adults IGlar: Children IGlar: Adolescents IGlar: Adults
    Started
    12
    13
    12
    12
    13
    12
    Exposed
    12
    13
    12
    12
    13
    12
    Completed
    12
    13
    12
    12
    13
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IDeg in Period 1
    Reporting group description
    		 In Period 1, subjects were randomly assigned to receive a single dose of IDeg.

    Reporting group title
    IGlar in Period 1
    Reporting group description
    		 In Period 1, subjects were randomly assigned to receive a single dose of IGlar.

    Reporting group values
    		 IDeg in Period 1 IGlar in Period 1 Total
    Number of subjects
    		 19 20 39
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 5 8 13
        Adolescents (12-17 years)
    		 5 8 13
        Adults (18-64 years)
    		 9 4 13
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 8 18
        Male
    		 9 12 21

    End points

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    End points reporting groups
    Reporting group title
    IDeg in Period 1
    Reporting group description
    		 In Period 1, subjects were randomly assigned to receive a single dose of IDeg.

    Reporting group title
    IGlar in Period 1
    Reporting group description
    		 In Period 1, subjects were randomly assigned to receive a single dose of IGlar.
    Reporting group title
    IDeg in Period 2
    Reporting group description
    		 Subjects, who received IGlar in Period 1, were assigned to receive a single dose of IDeg in Period 2. There was a wash-out period of 7-21 days in between Period 1 and Period 2.

    Reporting group title
    IGlar in Period 2
    Reporting group description
    		 Subjects, who received IDeg in Period 1, were assigned to receive a single dose of IGlar in Period 2. There was a wash-out period of 7-21 days in between Period 1 and Period 2.
    Reporting group title
    IDeg: Children
    Reporting group description
    		 Subjects (children [6-11 years]) were randomly assigned to receive a single dose of IDeg.

    Reporting group title
    IDeg: Adolescents
    Reporting group description
    		 Subjects (adolescents [12-17 years]) were randomly assigned to receive a single dose of IDeg.

    Reporting group title
    IDeg: Adults
    Reporting group description
    		 Subjects (adults [18-65 years]) were randomly assigned to receive a single dose of IDeg.

    Reporting group title
    IGlar: Children
    Reporting group description
    		 Subjects (children [6-11 years]) were randomly assigned to receive a single dose of IGlar.

    Reporting group title
    IGlar: Adolescents
    Reporting group description
    		 Subjects (adolescents [12-17 years]) were randomly assigned to receive a single dose of IDeg.

    Reporting group title
    IGlar: Adults
    Reporting group description
    		 Subjects (adults [18-65 years]) were randomly assigned to receive a single dose of IGlar.

    Primary: AUC_IDeg, 0-∞, SD, area under the serum IDeg concentration-time curve from 0 to infinity after single-dose

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    End point title
    		 AUC_IDeg, 0-∞, SD, area under the serum IDeg concentration-time curve from 0 to infinity after single-dose
    End point description
    End point type
    Primary
    End point timeframe
    0 to infinity
    End point values
    		 IDeg: Children IDeg: Adolescents IDeg: Adults
    Number of subjects analysed
    12
    13
    12
    Units: pmol*h/L
        geometric mean (geometric coefficient of variation)
    145891 ± 73
    130713 ± 30
    98594 ± 21
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The endpoints were log-transformed and analysed using an ANOVA model with age group and period as fixed effects and with different error-terms for each age-group.
    Comparison groups
    IDeg: Children v IDeg: Adults
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean ratio
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 2.24
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    IDeg: Adolescents v IDeg: Adults
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean ratio
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 1.64

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of first trial product administration to 7 to 21 days after last dosing visit.
    Adverse event reporting additional description
    Safety Analysis Set included all subjects receiving at least one dose of the investigational product 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
    13.1
    Reporting groups
    Reporting group title
    IDeg: Children (6-11 years)
    Reporting group description
    		 Subjects (children [6-11 years]), who received at least one dose of IDeg.

    Reporting group title
    IDeg: Adolescents (12-17 years)
    Reporting group description
    		 Subjects (adolescents [12-17 years]), who received at least one dose of IDeg.

    Reporting group title
    IDeg: Adults (18-65 years)
    Reporting group description
    		 Subjects (adults [18-65 years]), who received at least one dose of IDeg.

    Reporting group title
    IGlar: Children (6-11 years)
    Reporting group description
    		 Subjects (children [6-11 years]), who received at least one dose of IGlar.

    Reporting group title
    IGlar: Adolescents (12-17 years)
    Reporting group description
    		 Subjects (adolescents [12-17 years]), who received at least one dose of IGlar.

    Reporting group title
    IGlar: Adults (18-65 years)
    Reporting group description
    		 Subjects (adults [18-65 years]), who received at least one dose of IGlar.

    Serious adverse events
    		 IDeg: Children (6-11 years) IDeg: Adolescents (12-17 years) IDeg: Adults (18-65 years) IGlar: Children (6-11 years) IGlar: Adolescents (12-17 years) IGlar: Adults (18-65 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (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
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IDeg: Children (6-11 years) IDeg: Adolescents (12-17 years) IDeg: Adults (18-65 years) IGlar: Children (6-11 years) IGlar: Adolescents (12-17 years) IGlar: Adults (18-65 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Wrong drug administered
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    General disorders and administration site conditions
    Catheter site phlebitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    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
    18 Nov 2009
    The Protocol was amended mainly due to the following reasons: This trial was conducted with the purpose of investigating the pharmacokinetic properties of NN1250 (insulin degludec). To increase convenience for the children it was decided to allow the subjects and the investigator to decide on the injection site for insulin aspart. This had no influence on bioavailability and trial results. To align time windows on blood glucose sampling times with the time windows on the blood sampling for determination of insulin 454 and insulin glargine. For clarity on some of the question asked in relation to a hypoglycaemic episode. The period for when a hypoglycaemic episode is deemed as treatment emergent, had incorrectly been stated as until 5 days after last trial product administration, this should be 7 days. The period for when an adverse event is deemed as treatment emergent, had incorrectly been stated as until the follow up visit, this should be until 7 days after the last trial product administration.

    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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