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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with metformin IR or metformin XR in pediatric patients with type 2 diabetes who have inadequate glycemic control on metformin alone

    Summary
    EudraCT number
    		 2010-024568-16
    Trial protocol
    		 BE   Outside EU/EEA   GB   IT  
    Global end of trial date
    22 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2017
    First version publication date
    23 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CV181147
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB, S-151 85 Södertälje, Sweden
    Sponsor organisation address
    S-151 85 Södertälje, Sweden, Södertälje, Sweden, S-151 85
    Public contact
    Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV, AstraZeneca AB, Eva.Johnsson@astrazeneca.com
    Scientific contact
    Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV, AstraZeneca AB, +46 31 7762484 762 484, Eva.Johnsson@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000200-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
    14 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The protocol-specified objectives presented in this synoptic report include the following: • To assess the safety and tolerability of saxagliptin as add on to metformin therapy in pediatric subjects aged 10 to < 18 years when administered for up to 16 weeks of short term therapy and 52 weeks of total therapy.
    Protection of trial subjects
    Freely given informed consent was obtained prior to clinical trial participation. Minor’s parents or legally acceptable representatives gasve fully informed written consent. Assent was obtained according to local regulations and if child is mentally capable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2012
    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
    United States: 3
    Country: Number of subjects enrolled
    Mexico: 3
    Worldwide total number of subjects
    6
    EEA total number of subjects
    0
    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)
    1
    Adolescents (12-17 years)
    5
    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
    		 A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with metformin IR or metformin XR in pediatric patients with type 2 diabetes who have inadequate glycemic control on metformin.

    Pre-assignment
    Screening details
    		 Approximately 236 subjects were planned to be randomized to study treatment (118 subjects per treatment group). Six subjects were randomized and treated in the study, and are included in the data analyses presented within this report.

    Period 1
    Period 1 title
    Overall Study (overall 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
    		 Saxagliptin
    Arm description
    		 Saxagliptin 2.5 or 5 mg according to body weight
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg or 5 mg according to body weight once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching saxagliptin
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching saxagliptin once daily

    Number of subjects in period 1
    		Saxagliptin Placebo
    Started
    4
    2
    Completed
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Saxagliptin
    Reporting group description
    		 Saxagliptin 2.5 or 5 mg according to body weight

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching saxagliptin

    Reporting group values
    		 Saxagliptin Placebo Total
    Number of subjects
    		 4 2 6
    Age Categorical
    Units: participants
        <=18 years
    		 4 2 6
        Between 18 and 65 years
    		 0 0 0
        >=65 years
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.8 ( 1.1 ) 16 ( 1 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 4 2 6
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Saxagliptin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Saxagliptin 2.5 mg or 5 mg according to the bodyweight

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Saxagliptin matching placebo

    Subject analysis sets values
    		 Saxagliptin Placebo
    Number of subjects
    4
    2
    Age Categorical
    Units: participants
        <=18 years
    4
    4
        Between 18 and 65 years
    0
    0
        >=65 years
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.8 ( 1.1 )
    16 ( 1 )
    Gender, Male/Female
    Units: participants
        Female
    4
    2
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Saxagliptin
    Reporting group description
    		 Saxagliptin 2.5 or 5 mg according to body weight

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching saxagliptin

    Subject analysis set title
    Saxagliptin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Saxagliptin 2.5 mg or 5 mg according to the bodyweight

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Saxagliptin matching placebo

    Primary: Mean change in HbA1c from baseline to Week 16

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    End point title
    		 Mean change in HbA1c from baseline to Week 16 [1]
    End point description
    End point type
    Primary
    End point timeframe
    16 week short term treatment period
    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: No statistical analysis has been performed for this end point due to a small number of subjects in the study
    End point values
    		 Saxagliptin Placebo
    Number of subjects analysed
    4
    2
    Units: percentage
        arithmetic mean (standard deviation)
    -1 ( 0.62 )
    0.9 ( 0.14 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 week
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Saxagliptin
    Reporting group description
    		 Saxagliptin 2.5 or 5 mg according to body weight

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching saxagliptin

    Serious adverse events
    		 Saxagliptin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Saxagliptin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    1 / 2 (50.00%)
    Investigations
    Urine output increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Stomach pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    pharyngitis streptococcal
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Oct 2011
    To clearly reflect that the randomization to study drugs saxagliptin and placebo will be stratified by metformin (XR or IR).

    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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