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    Clinical Trial Results:
    An open-label, randomised, multicentre, single-dose, parallel group trial to evaluate pharmacokinetics and pharmacodynamics of empagliflozin in children and adolescents from 10 to less than 18 years of age with type 2 diabetes mellitus

    Summary
    EudraCT number
    		 2013-002304-14
    Trial protocol
    		 DE   Outside EU/EEA   AT   FR  
    Global end of trial date
    29 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Aug 2016
    First version publication date
    13 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1245.87
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02121483
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim (BI), +1 800 2430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim (BI), +1 800 2430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000082-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
    30 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this trial were to assess the pharmacokinetics and the pharmacodynamics of a single dose of empagliflozin in children and adolescents with type 2 diabetes mellitus.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
    Background therapy
    		 Patient could take Metformin or basal or multiple dose injection (MDI) insulin as background in addition to diet and exercise.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2014
    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
    France: 1
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    United States: 22
    Country: Number of subjects enrolled
    South Africa: 10
    Worldwide total number of subjects
    39
    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)
    6
    Adolescents (12-17 years)
    33
    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
    		 -

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subjects) met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding is not applicable as this trial was conducted in an open-label manner at the trial sites. Also, the trial is uncontrolled trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Empagliflozin 5mg
    Arm description
    		 Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Empagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.

    Arm title
    		 Empagliflozin 10mg
    Arm description
    		 Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Empagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.

    Arm title
    		 Empagliflozin 25mg
    Arm description
    		 Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Empagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.

    Number of subjects in period 1 [1]
    		Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Started
    9
    8
    10
    Completed
    9
    8
    10
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Empagliflozin 5mg
    Reporting group description
    		 Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.

    Reporting group title
    Empagliflozin 10mg
    Reporting group description
    		 Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.

    Reporting group title
    Empagliflozin 25mg
    Reporting group description
    		 Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.

    Reporting group values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg Total
    Number of subjects
    		 9 8 10 27
    Age categorical
    Units: Subjects
    Age Continuous
    Treated Set (TS): The TS included all patients who were allocated trial medication and received trial medication (empagliflozin).
    Units: Years
        arithmetic mean (standard deviation)
    		 13.7 ( 2 ) 14.5 ( 1.9 ) 14.2 ( 2.1 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 6 5 7 18
        Male
    		 3 3 3 9

    End points

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    End points reporting groups
    Reporting group title
    Empagliflozin 5mg
    Reporting group description
    		 Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.

    Reporting group title
    Empagliflozin 10mg
    Reporting group description
    		 Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.

    Reporting group title
    Empagliflozin 25mg
    Reporting group description
    		 Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.

    Primary: AUC0-inf

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    End point title
    		 AUC0-inf
    End point description
    Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.
    End point type
    Primary
    End point timeframe
    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    9 [1]
    8 [2]
    10 [3]
    Units: nmol*h/L
        geometric mean (geometric coefficient of variation)
    1150 ( 47.6 )
    1430 ( 17.2 )
    5060 ( 29.5 )
    Notes
    [1] - PKS
    [2] - PKS
    [3] - PKS
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.
    Comparison groups
    Empagliflozin 5mg v Empagliflozin 10mg v Empagliflozin 25mg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    0.949
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7276
         upper limit
    		 1.1704
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1075

    Primary: AUC0-tz

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    End point title
    		 AUC0-tz
    End point description
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).
    End point type
    Primary
    End point timeframe
    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    9 [4]
    8 [5]
    10 [6]
    Units: nmol*h/L
        geometric mean (geometric coefficient of variation)
    1110 ( 49.9 )
    1400 ( 17.1 )
    4980 ( 29.1 )
    Notes
    [4] - PKS
    [5] - PKS
    [6] - PKS
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.
    Comparison groups
    Empagliflozin 5mg v Empagliflozin 10mg v Empagliflozin 25mg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    0.9597
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7356
         upper limit
    		 1.1838
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1088

    Primary: Cmax

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    End point title
    		 Cmax
    End point description
    Maximum measured concentration in plasma (Cmax).
    End point type
    Primary
    End point timeframe
    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    9 [7]
    8 [8]
    10 [9]
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    159 ( 44.5 )
    188 ( 50.2 )
    602 ( 61.1 )
    Notes
    [7] - PKS
    [8] - PKS
    [9] - PKS
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.
    Comparison groups
    Empagliflozin 5mg v Empagliflozin 10mg v Empagliflozin 25mg
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Regression, Linear
    Parameter type
    		 Slope
    Point estimate
    0.8554
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5504
         upper limit
    		 1.1603
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1481

    Primary: tmax

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    End point title
    		 tmax [10]
    End point description
    Maximum measured concentration in plasma (tmax)
    End point type
    Primary
    End point timeframe
    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
    Notes
    [10] - 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    9 [11]
    8 [12]
    10 [13]
    Units: hours
        median (full range (min-max))
    1.5 (0.95 to 7.92)
    1.25 (0.967 to 4.17)
    1.78 (0.5 to 4)
    Notes
    [11] - PKS
    [12] - PKS
    [13] - PKS
    No statistical analyses for this end point

    Primary: t1/2

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    End point title
    		 t1/2 [14]
    End point description
    Terminal half-life in plasma (t1/2).
    End point type
    Primary
    End point timeframe
    Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
    Notes
    [14] - 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    9 [15]
    8 [16]
    10 [17]
    Units: hours
        geometric mean (geometric coefficient of variation)
    6.92 ( 19.4 )
    7.35 ( 29.3 )
    7.8 ( 29.6 )
    Notes
    [15] - PKS
    [16] - PKS
    [17] - PKS
    No statistical analyses for this end point

    Secondary: Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake

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    End point title
    		 Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake
    End point description
    Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake. For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘UGE at baseline’ and ‘FPG at baseline’ as continuous covariates. Means presented are the adjusted means. Treated Set (TS) including patients with UGE data on both visits is the population set used for the endpoint.
    End point type
    Secondary
    End point timeframe
    baseline and 24 hours
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    8 [18]
    8 [19]
    10 [20]
    Units: g/24h
        arithmetic mean (standard error)
    53.1 ( 10.24 )
    73 ( 10.14 )
    87.4 ( 9.39 )
    Notes
    [18] - TS
    [19] - TS
    [20] - TS
    No statistical analyses for this end point

    Secondary: Change from baseline in Fasting Plasma Glucose (FPG) at 24 h after study drug intake

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    End point title
    		 Change from baseline in Fasting Plasma Glucose (FPG) at 24 h after study drug intake
    End point description
    Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake. For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘FPG at baseline’ as continuous covariate. Means presented are the adjusted means. Treated Set (TS) including patients with FPG data on both visits was the population set used for this endpoint.
    End point type
    Secondary
    End point timeframe
    baseline and 24 hours
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    7 [21]
    8 [22]
    10 [23]
    Units: mg/dL
        arithmetic mean (standard error)
    -15.5 ( 6.53 )
    -16.6 ( 6.29 )
    -20.4 ( 5.68 )
    Notes
    [21] - TS
    [22] - TS
    [23] - TS
    No statistical analyses for this end point

    Secondary: Change from baseline in 8-point plasma glucose profile over 24 h after study drug intake

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    End point title
    		 Change from baseline in 8-point plasma glucose profile over 24 h after study drug intake
    End point description
    Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1). For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as fixed effect and ‘MDG at baseline’ as continuous covariate. Means presented are the adjusted means. Treated Set (TS) including patients with plasma glucose profile data on both visits is the population set used for this endpoint.
    End point type
    Secondary
    End point timeframe
    baseline and 24 hours
    End point values
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Number of subjects analysed
    5 [24]
    4 [25]
    7 [26]
    Units: mg/dL
        arithmetic mean (standard error)
    -12.9 ( 7.95 )
    -6.5 ( 9.21 )
    -13.2 ( 7 )
    Notes
    [24] - TS
    [25] - TS
    [26] - TS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events reported within 7 days following trial drug administration were considered on treatment, up to 8 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Empagliflozin 5mg
    Reporting group description
    		 Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.

    Reporting group title
    Empagliflozin 10mg
    Reporting group description
    		 Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.

    Reporting group title
    Empagliflozin 25mg
    Reporting group description
    		 Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.

    Serious adverse events
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Empagliflozin 5mg Empagliflozin 10mg Empagliflozin 25mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Anal pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2014
    In agreement with FDA and EMA/PDCO, patient on a stable dose of basal insulin (given alone or in combination with metformin treatment) could also be included in the trial and the clinical trial protocol was adapted throughout to accommodate for this change in the main criteria for inclusion. Exclusion Criterion No. 2 was modified to ‘History of acute metabolic de-compensation, such as diabetic ketoacidosis within 3 months before the screening visit with theexception of acute de-compensation at the time of T2DM diagnosis’, as it had been discussed at the Investigator Meeting that acute de-compensation at the time of diagnosis of T2DM was not to be a reason for exclusion and was therefore listed as an exception.
    09 Feb 2015
    The main criteria for inclusion as well as Inclusion Criteria No. 3 and 4 were adapted by removal of the lower HbA1c limit as well as by removal of a minimum dose of metformin and addition of stable dosing for metformin (for patients on metformin background therapy). As agreed with the FDA and the EMA/PDCO, these changes were to improve recruitment while accounting for special characteristics of paediatric patients with T2DM.
    29 Jul 2015
    As agreed with FDA and EMA/PDCO, patients on MDI insulin (with a maximum total daily dose) were to also be included in the trial. In addition, the weekly insulin dose change allowed prior to randomisation was revised. The clinical trial protocol was adapted throughout to accommodate for this change in the main criteria for inclusion. Metabolic acidosis, ketoacidosis, and diabetic ketoacidosis were added to the list of AESIs upon request by the FDA in order to collect as much information as possible about the potential risk in ongoing trials with SGLT-2 inhibitors. The potential risk of diabetic ketoacidosis during treatment with SGLT-2 inhibitors was added in the benefit-risk assessment. Furthermore, recommendations in case of diabetic ketoacidosis symptoms were given and diabetic ketoacidosis was defined as a reason for withdrawal of individual patients.

    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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