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    Clinical Trial Results:
    A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study with a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg once daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a background combination of Metformin and Sulfonylurea

    Summary
    EudraCT number
    		 2011-002231-26
    Trial protocol
    		 DE   CZ   SK   ES  
    Global end of trial date
    12 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2016
    First version publication date
    12 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1693C00005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01392677
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden1, Molndal, Sweden, SF-431 83
    Public contact
    Eva Johnsson, Astra Zeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Eva Johnsson, Astra Zeneca, ClinicalTrialTransparency@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
    18 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and SU and placebo in combination with metformin and SU.
    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 International Conference on Harmonisation/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples. The investigator at each center ensured that the patient, parent, guardian, or legal representative (as appropriate) was given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. The patient, parent, guardian, or legal representative (as appropriate) were notified that they were free to discontinue from the study at any time and were given the opportunity to ask questions and allowed time to consider the information provided.
    Background therapy
    		 Stable dose combination therapy of metformin at least 1500 mg each day and maximum tolerated dose which must be at least half maximum dose of sulfonylurea for at least 8 weeks prior to enrolment.
    Evidence for comparator
    		 Placebo-controlled.
    Actual start date of recruitment
    24 Oct 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 55
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Slovakia: 36
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Czech Republic: 28
    Worldwide total number of subjects
    218
    EEA total number of subjects
    163
    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)
    142
    From 65 to 84 years
    76
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of 859 participants enrolled, 736 completed the qualification phase. Of these 597 subjects were randomized and 596 received treatment and 262 were excluded due to adverse events (4), incorrect enrollment (229), withdrawn consent (23), lost to follow-up (2), and other reasons (4).

    Pre-assignment
    Screening details
    		 During enrollment, diet and life-style advice was given to participants and was reinforced during a placebo lead-in period. Dose of anti-hyperglycemic combination therapy of metformin >= 1500 mg/day and maximum tolerated dose which must be at least half the maximum dose of sulfonylurea for at least 8 weeks prior to enrollment were to remain stable.

    Period 1
    Period 1 title
    24-week Double-Blind (Full 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
    		 Placebo plus metformin plus sulfonylurea
    Arm description
    		 Placebo
    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
    QD

    Arm title
    		 Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Arm description
    		 Dapagliflozn 10 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Farxiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg oral administration

    Number of subjects in period 1 [1]
    		Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Started
    108
    108
    Completed
    101
    101
    Not completed
    7
    7
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    3
    1
         Other reason not completed
    4
    4
    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 summaries represent the full analysis set (FAS) and was provided to correspond with the analysis set evaluated in efficacy analyses. This population required subjects to receive at least one dose of study medication, and to have baseline and post-treatment assessments available for at least one efficacy parameter.The number of subjects in the FAS is less than the the number worldwide subjects enrolled in the trial

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo plus metformin plus sulfonylurea
    Reporting group description
    		 Placebo

    Reporting group title
    Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Reporting group description
    		 Dapagliflozn 10 mg

    Reporting group values
    		 Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea Total
    Number of subjects
    		 108 108 216
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 72 69 141
        From 65-74 years
    		 26 30 56
        75 years and over
    		 10 9 19
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 60.9 ( 9.24 ) 61.1 ( 9.65 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 48 62 110
        Male
    		 60 46 106
    Body Mass Index Category
    Percent
    Units: Subjects
        < 25 kg/m^2
    		 2 6 8
        >= 25 kg/m^2 - <27 kg/m^2
    		 11 12 23
        >=27 kg/m^2 - <30 kg/m^2
    		 26 23 49
        >=30 kg/m^2
    		 69 67 136
    Race
    Race
    Units: Subjects
        White
    		 102 104 206
        Black/African-American
    		 1 0 1
        Asian
    		 4 3 7
        Other
    		 1 1 2
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 1 1 2
        Not Hispanic/Latino
    		 107 107 214
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized subjects that received at least 1 dose of double-blind study medication, with a baseline and at least 1 post-baseline assessment for an efficacy paramter.

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    216
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    141
        From 65-74 years
    56
        75 years and over
    19
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    61 ( 9.42 )
    Gender, Male/Female
    Units: Participants
        Female
    110
        Male
    106
    Body Mass Index Category
    Percent
    Units: Subjects
        < 25 kg/m^2
    8
        >= 25 kg/m^2 - <27 kg/m^2
    23
        >=27 kg/m^2 - <30 kg/m^2
    49
        >=30 kg/m^2
    136
    Race
    Race
    Units: Subjects
        White
    206
        Black/African-American
    1
        Asian
    7
        Other
    2
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    2
        Not Hispanic/Latino
    214

    End points

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    End points reporting groups
    Reporting group title
    Placebo plus metformin plus sulfonylurea
    Reporting group description
    		 Placebo

    Reporting group title
    Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Reporting group description
    		 Dapagliflozn 10 mg

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized subjects that received at least 1 dose of double-blind study medication, with a baseline and at least 1 post-baseline assessment for an efficacy paramter.

    Primary: Adjusted mean change from baseline in Hemoglobin A1C (HbA1c) at Week 24 (Repeated Measures Model [RMM])

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    End point title
    		 Adjusted mean change from baseline in Hemoglobin A1C (HbA1c) at Week 24 (Repeated Measures Model [RMM])
    End point description
    HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the startdate and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment onor prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, and 24 in the double-blind period.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects analysed
    108
    108
    Units: Percent
        least squares mean (standard error)
    -0.17 ( 0.073 )
    -0.86 ( 0.0714 )
    Statistical analysis title
    		 Primary Endpoint Analysis
    Statistical analysis description
    H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0
    Comparison groups
    Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 -0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1022
    Notes
    [1] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives

    Secondary: Adjusted mean change from baseline in FPG at Week 24 (Last Observation Carried Forward [LOCF])

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    End point title
    		 Adjusted mean change from baseline in FPG at Week 24 (Last Observation Carried Forward [LOCF])
    End point description
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects analysed
    107
    108
    Units: mg/dL
        least squares mean (standard error)
    -0.78 ( 3.4424 )
    -34.23 ( 3.4262 )
    Statistical analysis title
    		 First Secondary Endpoint Analysis
    Statistical analysis description
    H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0
    Comparison groups
    Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -33.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.08
         upper limit
    		 -23.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8846
    Notes
    [2] - Last Observation Carried Forward (LOCF)
    [3] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives

    Secondary: Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])

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    End point title
    		 Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
    End point description
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1and Weeks 4, 8, 16, and 24 of the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects analysed
    108
    108
    Units: kg
        least squares mean (standard error)
    -0.58 ( 0.258 )
    -2.65 ( 0.258 )
    Statistical analysis title
    		 Second Secondary Endpoint Analysis
    Statistical analysis description
    HA: mean(treat) minus mean(placebo) =/= 0
    Comparison groups
    Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.79
         upper limit
    		 -1.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3651
    Notes
    [4] - Last Observation Carried Forward (LOCF)
    [5] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives

    Secondary: Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

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    End point title
    		 Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
    End point description
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects analysed
    108
    108
    Units: Percentage of participants
        least squares mean (standard error)
    11.1 ( 2.884 )
    31.8 ( 4.319 )
    Statistical analysis title
    		 Third Secondary Endpoint Analysis
    Statistical analysis description
    H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0
    Comparison groups
    Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.0001 [7]
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    20.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 30.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.056
    Notes
    [6] - Last Observation Carried Forward (LOCF)
    [7] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives

    Secondary: Adjusted Mean Change from Baseline in Seated Systolic Blood Pressure at Week 8 (Last Observation Carried Forward [LOCF])

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    End point title
    		 Adjusted Mean Change from Baseline in Seated Systolic Blood Pressure at Week 8 (Last Observation Carried Forward [LOCF])
    End point description
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was definedas the last assessment on or prior to the date of the first dose of the double-blind study medication. Systolic blood pressure measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 4, 8, 16, and 24 of the double-blind period.
    End point type
    Secondary
    End point timeframe
    From Baseline to week 8
    End point values
    		 Placebo plus metformin plus sulfonylurea Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects analysed
    105
    105
    Units: mmHg
        least squares mean (standard error)
    -0.27 ( 1.1782 )
    -4.04 ( 1.1782 )
    Statistical analysis title
    		 Fourth Secondary Endpoint Analysis
    Statistical analysis description
    H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0
    Comparison groups
    Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.025 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.05
         upper limit
    		 -0.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6677
    Notes
    [8] - Last Obaservation Carried Forward (LOCF)
    [9] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 52-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
    Adverse event reporting additional description
    Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Dapagliflozin 10mg plus metformin plus sulfonylurea
    Reporting group description
    		 Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea

    Reporting group title
    Placebo plus metformin plus sulfonylurea
    Reporting group description
    		 Placebo once daily plus background combination of metformin and sulfonylurea

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The number of non-serious AEs was not reported in the clinical study report in accordance with safety analysis conventions which required the numbers and percentages of subjects that experienced at least one non-serious adverse event. As the number of non-serious AEs and the corresponding numbers and percentages of subjects that experienced at least one non-serious event were not both available in the clinical study report, the absence of complete data as required could not be reported
    Serious adverse events
    		 Dapagliflozin 10mg plus metformin plus sulfonylurea Placebo plus metformin plus sulfonylurea
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 109 (6.42%)
    8 / 109 (7.34%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    renal cell carcinoma
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
    Additional description: Benign Lung Neoplasm
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injuries NEC
    Additional description: Vascular Rupture
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Penis deviation
    Additional description: Phimosis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    aortic valve stenosis
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arrhythmia
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Bleeding intracranial
    Additional description: Intracranial Haemorrhage
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischemia cerebral
    Additional description: Transient Ischaemic Attack
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatic neuralgia
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic organ injury
    Additional description: Pelvic Prolapse
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp of corpus uteri
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural disorder
    Additional description: Haemothorax
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus ureteric
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    sympathetic posterior cervical syndrome
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
    Additional description: Muskuloskeletal
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    diabetic gangrene
         subjects affected / exposed
    0 / 109 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal pneumonia
    Additional description: Pneumonia NOS
         subjects affected / exposed
    1 / 109 (0.92%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         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 plus metformin plus sulfonylurea Placebo plus metformin plus sulfonylurea
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 109 (0.00%)
    0 / 109 (0.00%)

    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.
    Last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints excluded data after rescue.Disposition for the full analysis set had fewer subjects than adverse event summaries, and fewer subjects than enrolled.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25592197
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