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    Clinical Trial Results:
    A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active-Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared with Sulphonylurea all given as Add-on Therapy to Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

    Summary
    EudraCT number
    		 2015-002376-24
    Trial protocol
    		 DE   HU   CZ   SK   PL  
    Global end of trial date
    24 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2018
    First version publication date
    29 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1689C00014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Cambridge Science Park, Cambridge, United Kingdom, CB4 0FZ
    Public contact
    Eva Johnsson, MD, PhD, AstraZeneca, +46 031776 24 84, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Eva Johnsson, MD, PhD, AstraZeneca, +46 031776 24 84, 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
    24 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to compare the absolute change from baseline in HbA1c at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin.
    Protection of trial subjects
    All subjects were monitored throughout the study to ensure adequate glycaemic control.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 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
    Germany: 470
    Country: Number of subjects enrolled
    Hungary: 167
    Country: Number of subjects enrolled
    Slovakia: 144
    Country: Number of subjects enrolled
    Poland: 87
    Country: Number of subjects enrolled
    Czech Republic: 71
    Worldwide total number of subjects
    939
    EEA total number of subjects
    939
    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)
    684
    From 65 to 84 years
    255
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Sites were allowed to perform a pre-study screening assessment prior to enrolment Visit to screen for HbA1c criteria. All potentially eligible subjects underwent screening and submitted laboratory samples at Enrolment (Visit 1, 2 weeks prior to randomisation).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dapagliflozin 10mg
    Arm description
    		 Dapagliflozin 10mg + Metformin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Dapagliflozin
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg, orally, green, plain, diamond-shaped, film-coated tablet

    Arm title
    		 Saxagliptin 5mg and Dapagliflozin 10mg
    Arm description
    		 Saxagliptin 5mg and Dapagliflozin 10mg + Metformin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxagliptin
    Investigational medicinal product code
    Saxagliptin
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg, orally, plain, yellow, biconvex, round, film-coated tablet

    Arm title
    		 Glimepiride 1mg/2mg/4mg
    Arm description
    		 Glimepiride 1mg/2mg/4mg + Metformin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Glimepiride
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1, 2, or 4 mg, orally, opaque gray capsule

    Number of subjects in period 1
    		Dapagliflozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg
    Started
    314
    312
    313
    Completed
    281
    298
    288
    Not completed
    33
    14
    25
         Consent withdrawn by subject
    8
    4
    5
         Adverse event, non-fatal
    7
    1
    2
         Failure to Meet Randomization Criteria
    2
    -
    1
         Developed Study Withdrawal Criteria
    4
    1
    2
         Lost to follow-up
    1
    1
    3
         Other reasons not specified
    10
    7
    12
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dapagliflozin 10mg
    Reporting group description
    		 Dapagliflozin 10mg + Metformin

    Reporting group title
    Saxagliptin 5mg and Dapagliflozin 10mg
    Reporting group description
    		 Saxagliptin 5mg and Dapagliflozin 10mg + Metformin

    Reporting group title
    Glimepiride 1mg/2mg/4mg
    Reporting group description
    		 Glimepiride 1mg/2mg/4mg + Metformin

    Reporting group values
    		 Dapagliflozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg Total
    Number of subjects
    		 314 312 313 939
    Age, Customized
    Units: Subjects
        <65|
    		 232 226 226 684
        >=65-<75|
    		 81 86 85 252
        >=75|
    		 1 0 2 3
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 57.4 ( 9.36 ) 59.2 ( 7.87 ) 58.6 ( 8.38 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 112 122 105 339
        Male
    		 202 190 208 600
    Race/Ethnicity, Customized
    Units: Subjects
        Asian|
    		 1 3 0 4
        Black Or African American|
    		 2 2 2 6
        White|
    		 311 307 311 929

    End points

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    End points reporting groups
    Reporting group title
    Dapagliflozin 10mg
    Reporting group description
    		 Dapagliflozin 10mg + Metformin

    Reporting group title
    Saxagliptin 5mg and Dapagliflozin 10mg
    Reporting group description
    		 Saxagliptin 5mg and Dapagliflozin 10mg + Metformin

    Reporting group title
    Glimepiride 1mg/2mg/4mg
    Reporting group description
    		 Glimepiride 1mg/2mg/4mg + Metformin

    Subject analysis set title
    Dapaglifozin 10mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Dapaglifozin 10mg + Metformin

    Subject analysis set title
    Saxagliptin 5mg and Dapagliflozin 10mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Saxagliptin 5mg and Dapagliflozin 10mg + Metformin

    Subject analysis set title
    Glimepiride 1mg/2mg/4mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Glimepiride 1mg/2mg/4mg + Metformin

    Primary: Change in Haemoglobin A1c (HbA1c) from baseline to week 52

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    End point title
    		 Change in Haemoglobin A1c (HbA1c) from baseline to week 52
    End point description
    Change in HbA1c from baseline (week 0) to week 52
    End point type
    Primary
    End point timeframe
    Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
    End point values
    		 Dapaglifozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg
    Number of subjects analysed
    309
    311
    305
    Units: HbA1c %
        least squares mean (standard error)
    -0.82 ( 0.049 )
    -1.2 ( 0.046 )
    -0.99 ( 0.048 )
    Statistical analysis title
    		 Dapaglifozin vs Glimepiride
    Statistical analysis description
    Non-Inferiority
    Comparison groups
    Dapaglifozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0294
         upper limit
    		 0.2986
    Notes
    [1] - The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.
    Statistical analysis title
    		 Saxagliptin and Dapagliflozin vs Glimepiride
    Statistical analysis description
    Non-Inferiority
    Comparison groups
    Saxagliptin 5mg and Dapagliflozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    616
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.001 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3443
         upper limit
    		 -0.0825
    Notes
    [2] - The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.
    [3] - For Superiority

    Secondary: Patients with at least one episode of confirmed hypoglycaemia

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    End point title
    		 Patients with at least one episode of confirmed hypoglycaemia
    End point description
    Proportion of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period
    End point type
    Secondary
    End point timeframe
    Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
    End point values
    		 Dapaglifozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg
    Number of subjects analysed
    311
    312
    309
    Units: Patients
    0
    1
    13
    Statistical analysis title
    		 Dapaglifozin vs Glimepiride
    Comparison groups
    Dapaglifozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    620
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -4.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.45
         upper limit
    		 -1.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.14
    Statistical analysis title
    		 Saxagliptin and Dapagliflozin vs Glimepiride
    Comparison groups
    Saxagliptin 5mg and Dapagliflozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    621
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -3.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.21
         upper limit
    		 -1.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.19

    Secondary: Change in total body weight from baseline at week 52

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    End point title
    		 Change in total body weight from baseline at week 52
    End point description
    Change in body weight from baseline (week 0) to week 52
    End point type
    Secondary
    End point timeframe
    Over the 52 week treatment period
    End point values
    		 Dapaglifozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg
    Number of subjects analysed
    311
    312
    308
    Units: Weight (kg)
        least squares mean (standard error)
    -3.54 ( 0.231 )
    -3.15 ( 0.219 )
    1.76 ( 0.224 )
    Statistical analysis title
    		 Dapaglifozin vs Glimepiride
    Comparison groups
    Dapaglifozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    619
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.93
         upper limit
    		 -4.67
    Statistical analysis title
    		 Saxagliptin and Dapagliflozin vs Glimepiride
    Comparison groups
    Saxagliptin 5mg and Dapagliflozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    620
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.52
         upper limit
    		 -4.29

    Secondary: Change in Fasting Plasma Glucose (FPG) from baseline to week 52

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    End point title
    		 Change in Fasting Plasma Glucose (FPG) from baseline to week 52
    End point description
    Change in FPG from baseline (week 0) to week 52
    End point type
    Secondary
    End point timeframe
    Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
    End point values
    		 Dapaglifozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg
    Number of subjects analysed
    309
    311
    308
    Units: FPG (mmol/L)
        least squares mean (standard error)
    -1.62 ( 0.106 )
    -2.08 ( 0.100 )
    -1.49 ( 0.105 )
    Statistical analysis title
    		 Dapaglifozin vs Glimepiride
    Comparison groups
    Dapaglifozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    617
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.374
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.16
    Statistical analysis title
    		 Saxagliptin and Dapagliflozin vs Glimepiride
    Comparison groups
    Saxagliptin 5mg and Dapagliflozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    619
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 -0.31

    Secondary: Time to rescue

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    End point title
    		 Time to rescue
    End point description
    Time to rescue during the 52 week double blind treatment period
    End point type
    Secondary
    End point timeframe
    Over the 52 week treatment period
    End point values
    		 Dapaglifozin 10mg Saxagliptin 5mg and Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg
    Number of subjects analysed
    311 [4]
    312 [5]
    309 [6]
    Units: Number
    311
    312
    309
    Notes
    [4] - Percentage rescued = 18.6
    [5] - Percentage rescued = 8.3
    [6] - Percentage rescued = 21.4
    Statistical analysis title
    		 Dapaglifozin vs Glimepiride
    Comparison groups
    Dapaglifozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    620
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.777
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.35
    Statistical analysis title
    		 Saxagliptin and Dapagliflozin vs Glimepiride
    Comparison groups
    Saxagliptin 5mg and Dapagliflozin 10mg v Glimepiride 1mg/2mg/4mg
    Number of subjects included in analysis
    621
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 0.57

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of study medication. Includes all data regardless of use of rescue treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Dapagliflozin 10mg
    Reporting group description
    		 Dapagliflozin 10mg + Metformin

    Reporting group title
    Glimepiride 1mg/2mg/4mg
    Reporting group description
    		 Glimepiride 1mg/2mg/4mg + Metformin

    Reporting group title
    Saxagliptin 5mg and Dapagliflozin 10mg
    Reporting group description
    		 Saxagliptin 5mg and Dapagliflozin 10mg + Metformin

    Serious adverse events
    		 Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg Saxagliptin 5mg and Dapagliflozin 10mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 313 (12.46%)
    35 / 312 (11.22%)
    22 / 312 (7.05%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic neuroma
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melanoma recurrent
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 313 (0.00%)
    2 / 312 (0.64%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somatic symptom disorder
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epicondylitis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 313 (0.00%)
    2 / 312 (0.64%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 313 (0.32%)
    2 / 312 (0.64%)
    3 / 312 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain stem infarction
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 313 (0.64%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vitritis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 313 (0.00%)
    2 / 312 (0.64%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 312 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder prolapse
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    2 / 313 (0.64%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid haemorrhage
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 313 (0.64%)
    2 / 312 (0.64%)
    2 / 312 (0.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle rigidity
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 313 (0.32%)
    2 / 312 (0.64%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plantar fasciitis
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 312 (0.00%)
    1 / 312 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Micrococcus infection
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 312 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reiter's syndrome
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 312 (0.00%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dapagliflozin 10mg Glimepiride 1mg/2mg/4mg Saxagliptin 5mg and Dapagliflozin 10mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 313 (9.27%)
    37 / 312 (11.86%)
    31 / 312 (9.94%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    29 / 313 (9.27%)
    37 / 312 (11.86%)
    31 / 312 (9.94%)
         occurrences all number
    40
    49
    39

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2016
    Number of study sites and number of subjects planned, other secondary objectives updated
    01 Nov 2016
    To update the HbA1c range and further clarification of hypoglycaemia
    12 Jan 2017
    Clarification of analysis set definition and adding superiority test to analyses

    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
    For support, Contact us.
    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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