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    Clinical Trial Results:
    A 24 Week Multicentre, Randomised, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years

    Summary
    EudraCT number
    		 2015-005041-31
    Trial protocol
    		 GB   HU   RO  
    Global end of trial date
    06 Apr 2020

    Results information
    Results version number
    		 v3(current)
    This version publication date
    13 Feb 2022
    First version publication date
    16 Oct 2020
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D1690C00017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02725593
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Forskargatan 18, Sudertalje, Sweden, 151 85
    Public contact
    Global Clinical Lead, AstraZeneca AB, +46 18872409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca AB, +46 18872409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000694-PIP01-09
    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
    06 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aimed to compare the mean change from baseline in glycated haemoglobin (HbA1c) achieved with dapagliflozin against the mean achieved with placebo after 24 weeks of double-blind add-on treatment in participants aged 10 to less than 25 years with type 2 diabetes mellitus (T2DM) who have inadequate glycaemic control on diet and exercise with metformin or insulin ± metformin.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with ICH/GCP, applicable regulatory requirements, and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2016
    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
    Hungary: 2
    Country: Number of subjects enrolled
    Israel: 13
    Country: Number of subjects enrolled
    Mexico: 16
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    72
    EEA total number of subjects
    2
    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)
    7
    Adolescents (12-17 years)
    46
    Adults (18-64 years)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 42 study centres in 7 countries worldwide.

    Pre-assignment
    Screening details
    		 Participants reported to the clinical study site for screening within 12 to 8 weeks of 1st study drug administration. 168 participants were screened and 72 participants were randomized and included in the full analysis set.

    Period 1
    Period 1 title
    Blinded treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg
    Arm description
    		 Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dapagliflozin 10 mg administered orally once daily.

    Arm title
    		 Placebo/ Dapagliflozin 10mg
    Arm description
    		 Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo administered orally once daily.

    Number of subjects in period 1
    		Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Started
    39
    33
    Received treatment
    39
    33
    Completed
    34
    27
    Not completed
    5
    6
         Consent withdrawn by subject
    4
    3
         Withdrawal by Parent/Guardian
    -
    2
         Lost to follow-up
    1
    1
    Period 2
    Period 2 title
    Long term extension
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg
    Arm description
    		 Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dapagliflozin 10 mg administered orally once daily.

    Arm title
    		 Placebo/ Dapagliflozin 10mg
    Arm description
    		 Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dapagliflozin 10 mg administered orally once daily.

    Number of subjects in period 2 [1]
    		Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Started
    33
    27
    Completed
    32
    24
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    3
    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: 1 participant who completed Period 1 did not enter the long-term extension.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dapagliflozin 10mg/ Dapagliflozin 10mg
    Reporting group description
    		 Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.

    Reporting group title
    Placebo/ Dapagliflozin 10mg
    Reporting group description
    		 Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.

    Reporting group values
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg Total
    Number of subjects
    		 39 33 72
    Age Categorical
    Units: Participants
        ≥10 and ≤15
    		 16 14 30
        >15 and <18
    		 13 10 23
        ≥18 and <25
    		 10 9 19
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 16.1 ( 3.3 ) 16.2 ( 3.6 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 24 19 43
        Male
    		 15 14 29
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 28 16 44
        Black or African American
    		 8 10 18
        Asian
    		 0 1 1
        Native Hawaiian or other Pacific Islander
    		 1 0 1
        American Indian or Alaska Native
    		 2 3 5
        Other
    		 0 3 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 12 12 24
        Not Hispanic or Latino
    		 26 21 47
        Unknown or Not Reported
    		 1 0 1
    Geographic Region
    Units: Subjects
        North America
    		 16 16 32
        Latin America
    		 7 9 16
        Europe
    		 16 8 24
        Asia/Pacific
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Dapagliflozin 10mg/ Dapagliflozin 10mg
    Reporting group description
    		 Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.

    Reporting group title
    Placebo/ Dapagliflozin 10mg
    Reporting group description
    		 Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
    Reporting group title
    Dapagliflozin 10mg/ Dapagliflozin 10mg
    Reporting group description
    		 Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.

    Reporting group title
    Placebo/ Dapagliflozin 10mg
    Reporting group description
    		 Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.

    Primary: Adjusted change from baseline in glycated haemoglobin (HbA1c) at Week 24

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    End point title
    		 Adjusted change from baseline in glycated haemoglobin (HbA1c) at Week 24
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Number of subjects analysed
    31
    23
    Units: Percentage of HbA1c
        least squares mean (standard error)
    -0.25 ( 0.30 )
    0.50 ( 0.34 )
    Statistical analysis title
    		 Dapagliflozin vs Placebo
    Comparison groups
    Dapagliflozin 10mg/ Dapagliflozin 10mg v Placebo/ Dapagliflozin 10mg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.101
    Method
    		 Mixed model repeated measures analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.45

    Secondary: Adjusted change from baseline in fasting plasma glucose (FPG) at Week 24

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    End point title
    		 Adjusted change from baseline in fasting plasma glucose (FPG) at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Number of subjects analysed
    31
    23
    Units: mmol/L
        least squares mean (standard error)
    -0.07 ( 0.53 )
    0.72 ( 0.61 )
    Statistical analysis title
    		 Dapagliflozin vs Placebo
    Comparison groups
    Dapagliflozin 10mg/ Dapagliflozin 10mg v Placebo/ Dapagliflozin 10mg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34
    Method
    		 Mixed model repeated measures analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.42
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.81

    Secondary: Percentage of participants who required glycemic rescue medication or permanently discontinued treatment due to lack of glycemic control

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    End point title
    		 Percentage of participants who required glycemic rescue medication or permanently discontinued treatment due to lack of glycemic control
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Number of subjects analysed
    39
    33
    Units: Percentage of participants
        number (not applicable)
    5.1
    9.1
    Statistical analysis title
    		 Dapagliflozin vs Placebo
    Comparison groups
    Dapagliflozin 10mg/ Dapagliflozin 10mg v Placebo/ Dapagliflozin 10mg
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.655
    Method
    		 Fisher’s exact test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.11
         upper limit
    		 9.62

    Secondary: Percentage of participants with baseline glycated haemoglobin (HbA1c) >= 7% who achieved HbA1c level < 7% at Week 24

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    End point title
    		 Percentage of participants with baseline glycated haemoglobin (HbA1c) >= 7% who achieved HbA1c level < 7% at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Number of subjects analysed
    28
    24
    Units: Percentage of participants
        number (not applicable)
    25.0
    4.2
    Statistical analysis title
    		 Dapagliflozin vs Placebo
    Comparison groups
    Dapagliflozin 10mg/ Dapagliflozin 10mg v Placebo/ Dapagliflozin 10mg
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.056
    Method
    		 Fisher’s exact test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 41.11

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to a maximum of 56 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Dapagliflozin 10mg/ Dapagliflozin 10mg
    Reporting group description
    		 -

    Reporting group title
    Placebo/ Dapagliflozin 10mg
    Reporting group description
    		 -

    Serious adverse events
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 33 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dapagliflozin 10mg/ Dapagliflozin 10mg Placebo/ Dapagliflozin 10mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 39 (61.54%)
    19 / 33 (57.58%)
    Investigations
    Weight increased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    2
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 33 (12.12%)
         occurrences all number
    6
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 33 (6.06%)
         occurrences all number
    2
    3
    Nausea
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 33 (0.00%)
         occurrences all number
    4
    0
    Toothache
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 33 (6.06%)
         occurrences all number
    1
    4
    Vomiting
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 39 (10.26%)
    1 / 33 (3.03%)
         occurrences all number
    4
    1
    Cough
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 33 (6.06%)
         occurrences all number
    2
    3
    Sinus congestion
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Microalbuminuria
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    2
    2
    Pain in extremity
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Fungal infection
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 39 (12.82%)
    2 / 33 (6.06%)
         occurrences all number
    5
    3
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 33 (3.03%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    3
    Dyslipidaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 33 (9.09%)
         occurrences all number
    1
    3
    Vitamin D deficiency
         subjects affected / exposed
    5 / 39 (12.82%)
    2 / 33 (6.06%)
         occurrences all number
    5
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2016
    The protocol was amended to incorporate new safety information related to DKA. Symptoms and predisposing factors for DKA were described for patients to be appropriately assessed and management of HbA1c values.
    13 Feb 2017
    The protocol was amended to reflect the end of Bristol Myers Squibb’s role in the study. The duration of the screening period was extended, and details relating to the masking of spot urine glucose, the study weeks relating to lack of glycaemic control criteria for initiation of rescue medication, and the use of third-party vendors for lost to follow-up patients were clarified.
    20 Sep 2017
    The protocol was amended to increase the number of participants randomized in the study to ensure that at least 50 patients would complete the 24-week treatment period on study drug and the Week 24 assessment.

    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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