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    Clinical Trial Results:
    A 26-week open label, randomised, 2-armed, parallel group, multi-centre trial investigating efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn in combination with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose of metformin ± other oral antidiabetic drug(s) ± basal insulin

    Summary
    EudraCT number
    		 2013-005500-33
    Trial protocol
    		 HU   IT   DE   HR   GR   ES   PT  
    Global end of trial date
    14 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2016
    First version publication date
    29 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN304-4093
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02131272
    WHO universal trial number (UTN)
    		 U1111-1151-4056
    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
    21 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin neutral protamine hagedorn (NPH) in combination with the maximum tolerated dose (MTD) of metformin and diet/exercise in controlling glycaemia, after 26 weeks of treatment, in children and adolescents (aged 10–17 years) with type 2 diabetes, who are insufficiently treated with the MTD of metformin ± other OAD(s) ± basal insulin.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice and FDA 21 CFR 312.120.
    Background therapy
    		 Subjects continued treatment with metformin on their pre-study dose(s) throughout the trial.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    11 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    India: 4
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    42
    EEA total number of subjects
    1
    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)
    3
    Adolescents (12-17 years)
    39
    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 following 12 countries screened subjects (no. of sites that randomised subjects within parentheses): Brazil (1), Germany (1), India (3), Israel (1), South Korea (1), Malaysia (3), Mexico (1), Russian Federation (1) Taiwan (3), Turkey (3), United States (6), Hungary (0). A total of 24 sites in 11 countries randomised subjects to treatment.

    Pre-assignment
    Screening details
    		 Subjects continued their treatment with metformin during the trial.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Insulin detemir + metformin + diet/exercise
    Arm description
    		 Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin detemir
    Investigational medicinal product code
    Other name
    Insulin detemir
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period.

    Arm title
    		 Insulin NPH + metformin + diet/exercise
    Arm description
    		 Subjects were treated with insulin NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin neutral protamine hagedorn (NPH)
    Investigational medicinal product code
    Other name
    Insulin human
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1−0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period.

    Number of subjects in period 1
    		Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Started
    20
    22
    Completed
    19
    20
    Not completed
    1
    2
         Withdrawal Criteria
    1
    -
         Consent withdrawn by subject
    -
    1
         Consent withdrawn by parent
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Insulin detemir + metformin + diet/exercise
    Reporting group description
    		 Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.

    Reporting group title
    Insulin NPH + metformin + diet/exercise
    Reporting group description
    		 Subjects were treated with insulin NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.

    Reporting group values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise Total
    Number of subjects
    		 20 22 42
    Age Categorical
    Units: Subjects
        Adolescents (10-14 years)
    		 9 11 20
        Adults (15-17 years)
    		 11 11 22
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15 ( 2.1 ) 15 ( 2.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 12 15 27
        Male
    		 8 7 15
    Glycosylated haemoglobin (HbA1c)
    Units: pecentage of glycosylated HbA1c
        arithmetic mean (standard deviation)
    		 8.72 ( 0.86 ) 8.95 ( 1.05 ) -
    Body weight standard deviation score (SDS)
    The body weight SD scores were derived from the age and sex of the subjects and the body weight together with growth curves defined for the reference population (US population).
    Units: standard deviation score
        arithmetic mean (standard deviation)
    		 1.532 ( 0.685 ) 1.26 ( 0.835 ) -

    End points

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    End points reporting groups
    Reporting group title
    Insulin detemir + metformin + diet/exercise
    Reporting group description
    		 Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.

    Reporting group title
    Insulin NPH + metformin + diet/exercise
    Reporting group description
    		 Subjects were treated with insulin NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.

    Primary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    Estimated mean change in glycosylated haemoglobin from baseline to week 26.
    End point type
    Primary
    End point timeframe
    From baseline to week 26
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20
    22
    Units: Pecentage of glycosylated haemoglobin
        least squares mean (standard error)
    -0.64 ( 0.32 )
    -0.81 ( 0.31 )
    Statistical analysis title
    		 Mixed model for repeated measurements (MMRM)
    Statistical analysis description
    HbA1c measurements were analysed using MMRM with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.
    Comparison groups
    Insulin detemir + metformin + diet/exercise v Insulin NPH + metformin + diet/exercise
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.3075 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment contrast
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 1.09
    Notes
    [1] - Efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.
    [2] - P value is reported for one-sided test.

    Secondary: Change in body weight standard deviation score (SDS)

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    End point title
    		 Change in body weight standard deviation score (SDS)
    End point description
    Change in body weight standard deviation score (SDS) from baseline to week 26. The SD scores were derived from the age and sex of the subjects and the body weight together with growth curves defined for the reference population (US population).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 26
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20
    22
    Units: standard deviation score
        arithmetic mean (standard deviation)
    0.006 ( 0.192 )
    0.098 ( 0.139 )
    No statistical analyses for this end point

    Secondary: Proportion of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment

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    End point title
    		 Proportion of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
    End point description
    Percentage of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    At week 26
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20
    21 [3]
    Units: Percentage of subjects
        number (not applicable)
    25
    33.3
    Notes
    [3] - Subjects who have been exposed for a minimum of 14 weeks are included in the analysis.
    No statistical analyses for this end point

    Secondary: Proportion of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment

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    End point title
    		 Proportion of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
    End point description
    Percentage of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    At Week 26
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20
    21 [4]
    Units: Percentage of subjects
        number (not applicable)
    30
    38.1
    Notes
    [4] - Subjects who have been exposed for a minimum of 14 weeks contributed to the analysis.
    No statistical analyses for this end point

    Secondary: Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes

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    End point title
    		 Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes
    End point description
    The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20
    22
    Units: Number of episodes
        Severe
    0
    0
        Blood glucose confirmed symptomatic
    0
    1
    No statistical analyses for this end point

    Secondary: Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes

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    End point title
    		 Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes
    End point description
    Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20 [5]
    22 [6]
    Units: Number of episodes
        Severe
    0
    0
        BG confirmed symptomatic
    4
    12
    Notes
    [5] - One subject contributed to the events reported in this arm.
    [6] - 5 subjects contributed to the events reported in this arm.
    No statistical analyses for this end point

    Secondary: Incidence of adverse events (AEs)

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    End point title
    		 Incidence of adverse events (AEs)
    End point description
    The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    During the 26 weeks of treatment
    End point values
    		 Insulin detemir + metformin + diet/exercise Insulin NPH + metformin + diet/exercise
    Number of subjects analysed
    20 [7]
    22 [8]
    Units: Number of events
    30
    41
    Notes
    [7] - AEs were reported by 8 subjects in this arm.
    [8] - AEs were reported by 13 subjects in this arm.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
    Adverse event reporting additional description
    Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Insulin NPH + metformin + diet/exercise
    Reporting group description
    		 Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.

    Reporting group title
    Insulin detemir + metformin + diet/exercise
    Reporting group description
    		 Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.

    Serious adverse events
    		 Insulin NPH + metformin + diet/exercise Insulin detemir + metformin + diet/exercise
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Insulin NPH + metformin + diet/exercise Insulin detemir + metformin + diet/exercise
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 22 (40.91%)
    8 / 20 (40.00%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Soft tissue injury
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 22 (4.55%)
    3 / 20 (15.00%)
         occurrences all number
    4
    4
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Lip dry
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 22 (13.64%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    4
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Gastroenteritis viral
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Viral infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2015
    • Reduced the number of fasting visits, blood samples and assessments. • Clinic visit 3 had been changed to a phone contact.• The trial population was updated to include subjects who were treated with a maximum tolerated dose of metformin or who had documented complete metformin intolerance.• An additional exclusion criterion had been added.• Additional text regarding the informed consent process had been added.

    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.
    The trial was terminated earlier than planned. Based on the low number of subjects, the conclusions should be interpreted with caution.
    For support, Contact us.
    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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