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    Clinical Trial Results:
    An 8-week, single centre, randomized, parallel-group, double-blind, placebo controlled phase IV trial to evaluate Dapagliflozin 10 mg once daily effects on insulin resistance in subjects with type 2 diabetes mellitus

    Summary
    EudraCT number
    		 2014-005377-36
    Trial protocol
    		 FI  
    Global end of trial date
    29 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2017
    First version publication date
    12 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1690C00025
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D
    Sponsor organisation address
    SE-431 83, Molndal, Sweden,
    Public contact
    Anna Maria Langkilde, CVMD Development, 46 317761000, annamaria.langkilde@astrazeneca.com
    Scientific contact
    Anna Maria Langkilde, CVMD Development, 46 317761000, annamaria.langkilde@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if dapagliflozin 10 mg once daily when compared to placebo improves insulin sensitivity in skeletal muscle after 8 weeks of treatment in type 2 diabetes mellitus (T2D) patients
    Protection of trial subjects
    At any time, subjects were free to discontinue IP or withdraw from the study (i.e., IP and assessments), without prejudice to further treatment. A subject that decided to discontinue IP was always asked about the reason(s) and the presence of any AEs. If possible, they were seen and assessed by an Investigator. If a subject withdrew after at least 4 weeks of treatment, the assessment normally scheduled at Visit 4 could be performed at the time of the withdrawal (except when the informed consent had been withdrawn). AEs were followed up and all remaining IP was returned by the subject.
    Background therapy
    		 Stable metformin, dipeptidyl peptidase-4 inhibitors (DPP-IV) or sulphonylurea treatment, or on stable treatment with metformin in combination with sulphonylurea or DPP-IV
    Evidence for comparator
    		 Placebo comparator represents absence of additional treatment with an anti-diabetic agent.
    Actual start date of recruitment
    23 Mar 2015
    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
    Finland: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    13
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects were recruited at a single invenstigative site in Turku, Finland

    Pre-assignment
    Screening details
    		 A total of 55 subjects were screened and 32 were randomised and treated.

    Period 1
    Period 1 title
    Randomized analysis set (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
    Blinding implementation details
    Double-blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dapagliflozin 10 MG
    Arm description
    		 Dapagliflozin 10 MG once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    A10BX09
    Other name
    Forxiga, Farxiga
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg taken orally once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching Dapagliflozin 10 MG
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet QD

    Number of subjects in period 1
    		Dapagliflozin 10 MG Placebo
    Started
    16
    16
    Completed
    15
    16
    Not completed
    1
    0
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dapagliflozin 10 MG
    Reporting group description
    		 Dapagliflozin 10 MG once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily

    Reporting group values
    		 Dapagliflozin 10 MG Placebo Total
    Number of subjects
    		 16 16 32
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 11 19
        From 65-84 years
    		 8 5 13
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.9 ( 7.4 ) 62.1 ( 8.4 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 3 4 7
        Male
    		 13 12 25
    Race
    Units: Subjects
        White
    		 16 16 32

    End points

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    End points reporting groups
    Reporting group title
    Dapagliflozin 10 MG
    Reporting group description
    		 Dapagliflozin 10 MG once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily

    Primary: Adjusted mean change from baseline in skeletal muscle insulin-stimulated glucose uptake

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    End point title
    		 Adjusted mean change from baseline in skeletal muscle insulin-stimulated glucose uptake
    End point description
    Least square mean estimates obtained from analysis of covariance model of change from baseline with model terms for treatment, sex, and baseline
    End point type
    Primary
    End point timeframe
    From baseline to Week 8
    End point values
    		 Dapagliflozin 10 MG Placebo
    Number of subjects analysed
    15
    16
    Units: umol/min/kg
        least squares mean (standard deviation)
    0.8404 ( 3.3226 )
    -0.3304 ( 5.1869 )
    Statistical analysis title
    		 Skeletal muscle insulin-stimulated glucose uptake
    Statistical analysis description
    Comparison of least square mean mean change from baseline in skeletal muscle insulin-stimulated glucose uptake from analysis of covariance model of change from baseline in skeletal muscle insulin-stimulated glucose uptake with terms for baseline, sex, and treatment
    Comparison groups
    Dapagliflozin 10 MG v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9984
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.0742
         upper limit
    		 3.0681

    Secondary: Adjusted mean change from baseline in adipose tissue insulin-stimulated glucose uptake

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    End point title
    		 Adjusted mean change from baseline in adipose tissue insulin-stimulated glucose uptake
    End point description
    Least square mean estimates obtained from analysis of covariance model of change from baseline with model terms for treatment, sex, and baseline
    End point type
    Secondary
    End point timeframe
    From baseline to Week 8
    End point values
    		 Dapagliflozin 10 MG Placebo
    Number of subjects analysed
    15
    16
    Units: umol/min/kg
        least squares mean (standard error)
    1.0412 ( 1.4992 )
    -0.6403 ( 1.3644 )
    Statistical analysis title
    		 Adipose tissue insulin-stimulated glucose uptake
    Statistical analysis description
    Comparison of least square mean mean change from baseline in adipose tissue insulin-stimulated glucose uptake from analysis of covariance model of change from baseline in adipose tissue insulin-stimulated glucose uptake with terms for baseline, sex, and treatment
    Comparison groups
    Dapagliflozin 10 MG v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.3794
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.6815
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1788
         upper limit
    		 5.5418
    Notes
    [1] - Least square mean estimates obtained from analysis of covariance model of change from baseline with model terms for treatment, sex, and baseline

    Secondary: Adjusted mean change from baseline in liver insulin-stimulated glucose uptake

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    End point title
    		 Adjusted mean change from baseline in liver insulin-stimulated glucose uptake
    End point description
    Least square mean estimates obtained from analysis of covariance model of change from baseline with model terms for treatment and baseline
    End point type
    Secondary
    End point timeframe
    From baseline to Week 8
    End point values
    		 Dapagliflozin 10 MG Placebo
    Number of subjects analysed
    15
    16
    Units: umol/min/kg
        least squares mean (standard error)
    0.2681 ( 1.7477 )
    1.5896 ( 1.52 )
    Statistical analysis title
    		 Liver insulin-stimulated gluocose uptake
    Statistical analysis description
    Comparison of least square mean mean change from baseline in liver insulin-stimulated glucose uptake from analysis of covariance model of change from baseline in liver insulin-stimulated glucose uptake with terms for baseline, sex, and treatment
    Comparison groups
    Dapagliflozin 10 MG v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5317
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3215
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6017
         upper limit
    		 2.9587

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first day of double-blind study medication to either four (non-serious AEs) or thirty (SAEs) days beyond the last dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Dapalgliflozin 10 MG
    Reporting group description
    		 Dapagliflozin 10 MG once daily added to stable metformin, sulphonylurea or DPP-IV alone or metformin in combination with sulphonylurea or DPP-IV

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily added to stable metformin, sulphonylurea or DPP-IV alone or metformin in combination with sulphonylurea or DPP-IV

    Serious adverse events
    		 Dapalgliflozin 10 MG Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (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
    		 Dapalgliflozin 10 MG Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 16 (37.50%)
    7 / 16 (43.75%)
    Investigations
    Blood gluocse decrease
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    orthostatic hypotension
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypoaesthesia
    Additional description: NOS
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Thirst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    4 / 16 (25.00%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Balanitis
    Additional description: NOS
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infections NEC
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Sinusitis
    Additional description: NOS
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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