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    Clinical Trial Results:
    A Comparative, Randomized, Open-Label, Multi-Center, Single Dose Pharmacokinetic, Pharmacodynamic and Safety Study of Alogliptin (12.5 mg and 25 mg) Between Children, Adolescents, and Adults with Type 2 (Non-Insulin Dependent) Diabetes Mellitus

    Summary
    EudraCT number
    		 2009-011221-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2016
    First version publication date
    29 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SYR-322_104
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00957268
    WHO universal trial number (UTN)
    		 U1111-1111-7810
    Sponsors
    Sponsor organisation name
    Takeda Development Center Americas, Inc.
    Sponsor organisation address
    One Takeda Parkway, Deerfield, United States, 60015
    Public contact
    Study Registration Call Centre, Takeda Global Research & Development Center, Inc., 001 800 778-2860, medicalinformation@tpna.com
    Scientific contact
    Study Registration Call Centre, Takeda Global Research & Development Center, Inc., 001 800 778-2860, medicalinformation@tpna.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000496-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 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.
    Protection of trial subjects
    All participants signed an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 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
    United States: 46
    Worldwide total number of subjects
    46
    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)
    2
    Adolescents (12-17 years)
    22
    Adults (18-64 years)
    21
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 6 investigative sites in the United States from 17 Sep 2009 to 22 Nov 2013.

    Pre-assignment
    Screening details
    		 Participants aged 10 to 65 with a diagnosis of type 2 diabetes mellitus were enrolled in 1 of 5 treatment groups and received 12.5 or 25 mg alogliptin once.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alogliptin 12.5 mg (age 10 to < 14 years)
    Arm description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alogliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alogliptin tablets

    Arm title
    		 Alogliptin 25 mg (Age 10 to < 14 Years)
    Arm description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alogliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alogliptin tablets

    Arm title
    		 Alogliptin 12.5 mg (Age 14 to < 18 Years)
    Arm description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alogliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alogliptin tablets

    Arm title
    		 Alogliptin 25 mg (Age 14 to < 18 Years)
    Arm description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alogliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alogliptin tablets

    Arm title
    		 Alogliptin 25 mg (Age 18 to 65 Years)
    Arm description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alogliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alogliptin tablets

    Number of subjects in period 1
    		Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Started
    5
    4
    8
    7
    22
    Completed
    5
    4
    7
    7
    22
    Not completed
    0
    0
    1
    0
    0
         'Voluntary Withdrawl '
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alogliptin 12.5 mg (age 10 to < 14 years)
    Reporting group description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 10 to < 14 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 12.5 mg (Age 14 to < 18 Years)
    Reporting group description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 14 to < 18 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 18 to 65 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years) Total
    Number of subjects
    		 5 4 8 7 22 46
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.4 ( 0.89 ) 12 ( 0.82 ) 15.4 ( 0.92 ) 15.1 ( 0.69 ) 51.3 ( 8.24 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 3 6 5 16 34
        Male
    		 1 1 2 2 6 12
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 0 1 1 1 4 7
        Non-Hispanic or Latina
    		 5 3 7 6 18 39
    Race/Ethnicity
    Units: Subjects
        Asian Black or African American
    		 5 3 4 5 15 32
        White
    		 0 1 4 2 7 14
    Smoking Status
    Units: Subjects
        Never Smoked
    		 5 4 8 7 14 38
        Current Smoker
    		 0 0 0 0 0 0
        Ex-Smoker
    		 0 0 0 0 8 8
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 162.4 ( 8.56 ) 165.8 ( 8.88 ) 168.6 ( 5.71 ) 168.9 ( 9.03 ) 167.5 ( 9.81 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 86.62 ( 13.979 ) 98.9 ( 11.957 ) 116.28 ( 33.163 ) 103.71 ( 17.103 ) 92.25 ( 16.454 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 32.22 ( 4.621 ) 36.16 ( 3.422 ) 40.92 ( 9.19 ) 36.46 ( 6.764 ) 32.84 ( 4.49 ) -

    End points

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    End points reporting groups
    Reporting group title
    Alogliptin 12.5 mg (age 10 to < 14 years)
    Reporting group description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 10 to < 14 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 12.5 mg (Age 14 to < 18 Years)
    Reporting group description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 14 to < 18 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 18 to 65 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subject who received at least one dose of study drug

    Primary: Cmax: Maximum Observed Plasma Concentration for Alogliptin

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    End point title
    		 Cmax: Maximum Observed Plasma Concentration for Alogliptin [1]
    End point description
    Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
    End point type
    Primary
    End point timeframe
    1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose
    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 analysis was only descriptive.
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [2]
    7
    22
    Units: ng/mL
        arithmetic mean (standard deviation)
    57.82 ( 31.5546 )
    101.38 ( 23.4277 )
    44.24 ( 16.7907 )
    96.74 ( 28.3818 )
    135.5 ( 34.2169 )
    Notes
    [2] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Primary: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin

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    End point title
    		 Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin [3]
    End point description
    Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
    End point type
    Primary
    End point timeframe
    1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose
    Notes
    [3] - 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 analysis was only descriptive.
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [4]
    7
    22
    Units: hour
        arithmetic mean (standard deviation)
    3.24 ( 1.106 )
    2.04 ( 0.0462 )
    5.58 ( 8.2052 )
    2.86 ( 1.4707 )
    2.09 ( 1.1566 )
    Notes
    [4] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Primary: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin

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    End point title
    		 AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin [5]
    End point description
    AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).
    End point type
    Primary
    End point timeframe
    1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose
    Notes
    [5] - 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 analysis was only descriptive.
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [6]
    7
    22
    Units: ng•hr/mL
        arithmetic mean (standard deviation)
    789.29 ( 144.0995 )
    1221.96 ( 128.0268 )
    688.63 ( 188.7887 )
    1318.41 ( 123.6279 )
    1704.02 ( 270.6604 )
    Notes
    [6] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

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    End point title
    		 Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
    End point description
    The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [7]
    7
    22
    Units: Percentage inhibition•hr
        arithmetic mean (standard deviation)
    1569.633 ( 115.9662 )
    1698.852 ( 74.1622 )
    1557.788 ( 179.517 )
    1854.391 ( 63.7486 )
    1890.012 ( 71.4549 )
    Notes
    [7] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

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    End point title
    		 Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
    End point description
    The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [8]
    7
    22
    Units: Percantage inhibition
        arithmetic mean (standard deviation)
    83.66 ( 4.1446 )
    89.3 ( 2.642 )
    81.643 ( 5.9267 )
    90.429 ( 1.7327 )
    92.65 ( 2.0068 )
    Notes
    [8] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

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    End point title
    		 Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
    End point description
    The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [9]
    7
    22
    Units: hour
        median (full range (min-max))
    4.05 (2 to 4.08)
    2.08 (2 to 4)
    4 (2 to 4.03)
    4 (3.97 to 4.12)
    2 (2 to 4.07)
    Notes
    [9] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

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    End point title
    		 Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition
    End point description
    The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [10]
    7
    21 [11]
    Units: Percentge inhibition
        arithmetic mean (standard deviation)
    52 ( 10.2976 )
    57.375 ( 5.1292 )
    55.4 ( 9.0239 )
    70.4 ( 5.766 )
    72.843 ( 5.2949 )
    Notes
    [10] - 1 Participant did not have data available for analysis.
    [11] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

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    End point title
    		 Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
    End point description
    The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [12]
    7
    21 [13]
    Units: pmol•hr/L
        arithmetic mean (standard deviation)
    117.842 ( 92.8964 )
    120.055 ( 60.6825 )
    168.099 ( 116.283 )
    122.948 ( 98.3822 )
    278.669 ( 102.3304 )
    Notes
    [12] - 1 Participant did not have data available for analysis.
    [13] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

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    End point title
    		 Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
    End point description
    The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [14]
    7
    21 [15]
    Units: pmol/L
        arithmetic mean (standard deviation)
    11.7 ( 4.6357 )
    7.475 ( 3.8767 )
    16.5 ( 15.0423 )
    9.129 ( 6.6668 )
    23.843 ( 12.1143 )
    Notes
    [14] - 1 Participant did not have data available for analysis.
    [15] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

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    End point title
    		 Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
    End point description
    The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [16]
    7
    21 [17]
    Units: hour
        median (full range (min-max))
    8.17 (8.03 to 12)
    11.985 (8 to 12)
    11.92 (8 to 12)
    8.02 (4 to 24)
    12 (2.33 to 24.02)
    Notes
    [16] - 1 Participant did not have data available for analysis.
    [17] - 1 Participant did not have data available for analysis.
    No statistical analyses for this end point

    Secondary: Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

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    End point title
    		 Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration
    End point description
    The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.
    End point type
    Secondary
    End point timeframe
    1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose
    End point values
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Number of subjects analysed
    5
    4
    7 [18]
    7
    21 [19]
    Units: pmol/L
        arithmetic mean (standard deviation)
    2.5 ( 5.3282 )
    4.575 ( 3.6372 )
    4.214 ( 5.2737 )
    4.329 ( 6.2203 )
    5.419 ( 6.2064 )
    Notes
    [18] - 1 Participant did not have data available for analysis.
    [19] - 1 participants did not have data available for analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Up to 31 days).
    Adverse event reporting additional description
    Safety set: All enrolled participants who received at least 1 dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Alogliptin 12.5 mg (age 10 to < 14 years)
    Reporting group description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 10 to < 14 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 12.5 mg (Age 14 to < 18 Years)
    Reporting group description
    		 Alogliptin 12.5 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 14 to < 18 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Reporting group title
    Alogliptin 25 mg (Age 18 to 65 Years)
    Reporting group description
    		 Alogliptin 25 mg, tablets, orally, 1 dose only.

    Serious adverse events
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (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
    		 Alogliptin 12.5 mg (age 10 to < 14 years) Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg (Age 18 to 65 Years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 4 (25.00%)
    5 / 8 (62.50%)
    2 / 7 (28.57%)
    9 / 22 (40.91%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Haematocrit decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vascular disorders
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    0
    1
    0
    4
    Presyncope
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nodule
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Tenderness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    0
    3
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash papular
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    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
    11 May 2009
    A substantial amendment was written that included revision to the study design to increase the number of study subjects, revision of inclusion criteria, revision of the exclusion criteria, inclusion of an additional regimen of alogliptin, clarification of Informed Consent Requirements, analysis of additional safety points, inclusion of updated safety information, revision of labs and blood volume, clarification of study procedures, and an update of the adverse event list.
    06 Jul 2009
    A substantial amendment was written that included revision of safety labs, revision of inclusion criteria, clarification of dosing, and updated methods of contraception.
    03 Aug 2009
    A substantial amendment was written that included revision of inclusion criteria, revision of exclusion criteria, revision of overdose criteria, revision of safety labs, and the addition of a follow-up phone call.
    17 Nov 2009
    A substantial amendment was written that included revision of inclusion criteria and safety labs.
    13 Apr 2010
    A substantial amendment was written that included revision of inclusion criteria and safety labs.
    13 Jul 2010
    A substantial amendment was written that included the deletion of 3 pharmacokinetic samples, reduction of total blood volume, revision of contraception information, and review and approval of all medications by the Investigator and the Takeda Medical Monitor due to changes in the exclusionary medication criteria.
    07 Dec 2011
    A substantial amendment was written that included revision of inclusion criteria, reduction of the sample size from 72 to 48 participants, and revision of safety labs.
    12 Mar 2012
    A substantial amendment was written that included clarification of study procedures, addition of a fasting insulin test to establish a baseline, and inclusion of a summary of plasma glucose and fasting insulin as part of the pharmacodynamic paramenters.

    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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