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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy with Saxagliptin added to Dapagliflozin in Combination with Metformin compared to Therapy with Placebo added to Dapagliflozin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Dapagliflozin

    Summary
    EudraCT number
    		 2011-006323-37
    Trial protocol
    		 CZ   HU   PL  
    Global end of trial date
    12 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2016
    First version publication date
    01 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CV181-168
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01619059
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Västra Mälarehamnen 9, Södertälje, Sweden, S-151851170
    Public contact
    Eva Johnsson, AstraZeneca AB, 46 +46 31 7762484, Eva.Johnsson@astrazeneca.com
    Scientific contact
    Eva Johnsson, AstraZeneca AB, 46 +46 31 7762484, Eva.Johnsson@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 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
    Protection of trial subjects
    Study eligibility was based on inclusion and exclusion criteria. Eligible subjects entered the 24-week, short-term, double-blind treatment period, and were randomly assigned by the Interactive Voice Response System (IVRS). Randomization schedules for both subject treatment and containers were generated and kept by the Randomization Center located within the Drug Supply Management Department at BMS and stored in a secure location with restricted access
    Background therapy
    		 Dapagliflozin plus metformin
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jun 2012
    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
    Canada: 90
    Country: Number of subjects enrolled
    Czech Republic: 24
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Mexico: 137
    Country: Number of subjects enrolled
    Puerto Rico: 13
    Country: Number of subjects enrolled
    Romania: 64
    Country: Number of subjects enrolled
    Russian Federation: 133
    Country: Number of subjects enrolled
    United States: 336
    Country: Number of subjects enrolled
    Poland: 45
    Worldwide total number of subjects
    857
    EEA total number of subjects
    148
    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)
    705
    From 65 to 84 years
    152
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrollment: 857 subjects

    Pre-assignment
    Screening details
    		 Open-lable Period: 484 subjects Completed Open-lable Period: 431 subjects Randomized to Short-Term (ST) Treatment Period: 315 subjects Entered Long-Term (LT) Treatment Period: 297 subjects

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Dapagliflozin 10mg + Metformin
    Arm description
    		 Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
    Arm type
    		 Active comparator

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

    Arm title
    		 Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Arm description
    		 Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Arm 2

    Number of subjects in period 1 [1]
    		Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Started
    162
    153
    Completed
    156
    142
    Not completed
    6
    11
         Consent withdrawn by subject
    2
    5
         Adverse event, non-fatal
    1
    -
         Non-compliance, not Met Study Criteria
    1
    2
         Lost to follow-up
    2
    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: Of 315 participants randomized, 298 completed Short-Term (ST) treatment period. Of 297 participants entered Long-Term (LT) treatment period, 280 completed.
    Period 2
    Period 2 title
    Long-Term (LT) Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Dapagliflozin 10mg + Metformin
    Arm description
    		 Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo + Dapagliflozin 10mg + Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Tablet
    Routes of administration
    Oral use, Oral use
    Dosage and administration details
    Placebo + Dapagliflozin 10mg + Metformin

    Arm title
    		 Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Arm description
    		 Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin

    Number of subjects in period 2 [2]
    		Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Started
    155
    142
    Completed
    147
    133
    Not completed
    8
    9
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    3
    2
         Adverse event, non-fatal
    2
    3
         Not Met Study Criteria
    -
    1
         Lost to follow-up
    2
    2
         Lack of efficacy
    -
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Of 315 participants randomized, 298 completed Short-Term (ST) treatment period. Of 297 participants entered Long-Term (LT) treatment period, 280 completed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Reporting group title
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Reporting group values
    		 Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin Total
    Number of subjects
    		 162 153 315
    Age categorical
    Units: Subjects
        Adults (<65 years)
    		 140 132 272
        Adults (>=65 years)
    		 22 21 43
    Age Continuous |
    Units: YEARS
        arithmetic mean (standard deviation)
    		 54.5 ( 9.32 ) 54.7 ( 9.83 ) -
    Gender, Male/Female
    Units: Participants
        FEMALE
    		 76 73 149
        MALE
    		 86 80 166
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    		 8 5 13
        BLACK/AFRICAN AMERICAN
    		 9 11 20
        OTHER
    		 4 1 5
        WHITE
    		 141 136 277
    Subject analysis sets

    Subject analysis set title
    Randomized and Treated Subjects Data Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Randomized and Treated Subjects Data Set

    Subject analysis sets values
    		 Randomized and Treated Subjects Data Set
    Number of subjects
    315
    Age categorical
    Units: Subjects
        Adults (<65 years)
    272
        Adults (>=65 years)
    43
    Age Continuous |
    Units: YEARS
        arithmetic mean (standard deviation)
    54.6 ( 9.56 )
    Gender, Male/Female
    Units: Participants
        FEMALE
    166
        MALE
    149
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    13
        BLACK/AFRICAN AMERICAN
    20
        OTHER
    5
        WHITE
    277

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Reporting group title
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
    Reporting group title
    Placebo + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Reporting group title
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Subject analysis set title
    Randomized and Treated Subjects Data Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Randomized and Treated Subjects Data Set

    Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24

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    End point title
    		 Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
    End point description
    HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Number of subjects analysed
    149
    139
    Units: Percent
        least squares mean (standard error)
    -0.16 ( 0.0605 )
    -0.51 ( 0.0624 )
    Statistical analysis title
    		 Mean Change From Baseline in HBA1C
    Statistical analysis description
    Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
    Comparison groups
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin v Placebo + Dapagliflozin 10mg + Metformin
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 -0.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.087
    Notes
    [1] - Tested at alpha=0.05

    Secondary: Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) from a Liquid Meal Tolerance Test (MTT) at Week 24

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    End point title
    		 Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) from a Liquid Meal Tolerance Test (MTT) at Week 24
    End point description
    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Number of subjects analysed
    144
    135
    Units: mg/dL
        least squares mean (standard error)
    -31.3 ( 3.182 )
    -37.1 ( 3.286 )
    Statistical analysis title
    		 Mean Change From Baseline in PPG
    Statistical analysis description
    Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) from a Liquid Meal Tolerance Test (MTT) at Week 24
    Comparison groups
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin v Placebo + Dapagliflozin 10mg + Metformin
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2014 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.9
         upper limit
    		 3.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.576
    Notes
    [2] - Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure

    Secondary: Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24

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    End point title
    		 Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24
    End point description
    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    		 Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Number of subjects analysed
    146
    139
    Units: mg/dL
        least squares mean (standard error)
    -5.3 ( 2.59 )
    -9.1 ( 2.644 )
    Statistical analysis title
    		 Mean Change From Baseline in FPG
    Statistical analysis description
    Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24
    Comparison groups
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin v Placebo + Dapagliflozin 10mg + Metformin
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.713

    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
    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
    From Baseline to Week 24
    End point values
    		 Placebo + Dapagliflozin 10mg + Metformin Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Number of subjects analysed
    146
    139
    Units: Percent of participants
        number (confidence interval)
    23.1 (16.9 to 29.3)
    35.3 (28.2 to 42.4)
    Statistical analysis title
    		 Glycemic Response HbA1C <7.0%
    Statistical analysis description
    Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
    Comparison groups
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin v Placebo + Dapagliflozin 10mg + Metformin
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.4
         upper limit
    		 21
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.504

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Short-term + Long-term Treatment Period - Including Data After Rescue - Treated Subjects
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Saxagliptin 5mg + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Reporting group title
    Placebo + Dapagliflozin 10mg + Metformin
    Reporting group description
    		 Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

    Serious adverse events
    		 Saxagliptin 5mg + Dapagliflozin 10mg + Metformin Placebo + Dapagliflozin 10mg + Metformin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 153 (4.58%)
    11 / 162 (6.79%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HEPATIC CANCER
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (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 ARTERY THROMBOSIS
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL VASCULAR DISORDER
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERNIA
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    UTERINE HAEMORRHAGE
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    STAPHYLOCOCCUS TEST POSITIVE
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ANGINA PECTORIS
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    SYNCOPE
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    RETINAL DETACHMENT
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    COLITIS
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    DIABETIC FOOT
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN ULCER
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    RHABDOMYOLYSIS
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (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
    PYELONEPHRITIS
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Saxagliptin 5mg + Dapagliflozin 10mg + Metformin Placebo + Dapagliflozin 10mg + Metformin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 153 (24.18%)
    37 / 162 (22.84%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    9 / 153 (5.88%)
    12 / 162 (7.41%)
         occurrences all number
    12
    13
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    8 / 153 (5.23%)
    6 / 162 (3.70%)
         occurrences all number
    8
    6
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 153 (5.88%)
    8 / 162 (4.94%)
         occurrences all number
    10
    8
    URINARY TRACT INFECTION
         subjects affected / exposed
    11 / 153 (7.19%)
    11 / 162 (6.79%)
         occurrences all number
    16
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2012
    The objective of this Amendment is to permit the collection and storage of blood samples

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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