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    Clinical Trial Results:
    A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

    Due to a system error, the data reported in v1 and v2 are not correct and have been removed from public view.
    Summary
    EudraCT number
    		 2010-020053-14
    Trial protocol
    		 DE   AT   BE   NL   DK  
    Global end of trial date
    09 Mar 2012

    Results information
    Results version number
    		 v3(current)
    This version publication date
    15 Jul 2016
    First version publication date
    28 Jan 2015
    Other versions
    		 v1 (removed from public view) , v2 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    28431754DIA3015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01137812
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands, B235-0
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    09 Mar 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of the addition of treatment with canagliflozin compared with the addition of treatment with sitagliptin on HbA1c after 52 weeks. To assess the safety and tolerability of canagliflozin
    Protection of trial subjects
    A company internal Medical Safety Review Committee (MSRC) was established to monitor the safety of participants participating in this study. The MSRC included, but will not be limited to, at least 1 medical expert and at least 1 statistician. The MSRC was composed of individuals from the sponsor organization. The MSRC monitored the progress of the study by reviewing blinded data on a regular basis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 46
    Country: Number of subjects enrolled
    Brazil: 156
    Country: Number of subjects enrolled
    Canada: 86
    Country: Number of subjects enrolled
    India: 56
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Malaysia: 24
    Country: Number of subjects enrolled
    New Zealand: 24
    Country: Number of subjects enrolled
    Singapore: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 19
    Country: Number of subjects enrolled
    Ukraine: 46
    Country: Number of subjects enrolled
    United States: 243
    Worldwide total number of subjects
    756
    EEA total number of subjects
    88
    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)
    612
    From 65 to 84 years
    142
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between 30 June 2010 and 09 March 2012 and recruited participants from 140 study centers located in 17 countries worldwide.

    Pre-assignment
    Screening details
    		 A total of 756 participants were randomly allocated to the 2 treatment arms in the study. 755 participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and the safety analysis set.

    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
    		 Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Canagliflozin 300 mg
    Arm description
    		 Canagliflozin 300 milligram (mg) capsule once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with 300 mg Canagliflozin capsule once a daily.

    Arm title
    		 Sitagliptin 100 mg
    Arm description
    		 Sitagliptin 100 mg capsule orally once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with 100 mg sitagliptin capsule once daily.

    Number of subjects in period 1 [1]
    		Canagliflozin 300 mg Sitagliptin 100 mg
    Started
    377
    378
    Completed
    254
    210
    Not completed
    123
    168
         Creatinine or eGFR withdrawal criteria
    22
    14
         Consent withdrawn by subject
    5
    13
         Physician decision
    2
    3
         Adverse event, non-fatal
    21
    14
         Death
    2
    -
         Study terminated by sponsor
    1
    -
         Noncompliance with study drug
    4
    4
         Unspecified
    19
    27
         Participant met glycemic withdrawal criteria
    40
    85
         Lost to follow-up
    6
    8
         Protocol deviation
    1
    -
    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: One subject was randomly assigned to canagliflozin 300 mg group, but not dosed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Canagliflozin 300 mg
    Reporting group description
    		 Canagliflozin 300 milligram (mg) capsule once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.

    Reporting group title
    Sitagliptin 100 mg
    Reporting group description
    		 Sitagliptin 100 mg capsule orally once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.

    Reporting group values
    		 Canagliflozin 300 mg Sitagliptin 100 mg Total
    Number of subjects
    		 377 378 755
    Age categorical
    Units: Subjects
        Less Than and Equal to (<=) 18 years
    		 0 0 0
        Between 18 and 65 years
    		 304 307 611
        Greater Than and Equal to (>=) 65 years
    		 73 71 144
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.6 ( 9.62 ) 56.7 ( 9.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 170 163 333
        Male
    		 207 215 422

    End points

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    End points reporting groups
    Reporting group title
    Canagliflozin 300 mg
    Reporting group description
    		 Canagliflozin 300 milligram (mg) capsule once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.

    Reporting group title
    Sitagliptin 100 mg
    Reporting group description
    		 Sitagliptin 100 mg capsule orally once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.

    Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52

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    End point title
    		 Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
    End point description
    Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Here "n" defines the number of participants who analysed for this end point.
    End point type
    Primary
    End point timeframe
    Day 1 (Baseline), Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    377
    378
    Units: percent
    arithmetic mean (standard deviation)
        Baseline (n = 374, 365)
    8.12 ( 0.91 )
    8.13 ( 0.916 )
        Change at week 52 (n= 374, 365)
    -1 ( 0.94 )
    -0.63 ( 1.022 )
    Statistical analysis title
    		 Week 52: Change From Baseline in HbA1c
    Statistical analysis description
    If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference [canagliflozin minus sitagliptin] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.
    Comparison groups
    Sitagliptin 100 mg v Canagliflozin 300 mg
    Number of subjects included in analysis
    755
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.064
    Notes
    [1] - Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.

    Secondary: Percentage of Participants With HbA1c Less Than (<) 7% at Week 52

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    End point title
    		 Percentage of Participants With HbA1c Less Than (<) 7% at Week 52
    End point description
    Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    374
    365
    Units: Percentage of Participants
        number (not applicable)
    47.6
    35.3
    Statistical analysis title
    		 Week 52: Percentage of Participants With HbA1c <7%
    Comparison groups
    Canagliflozin 300 mg v Sitagliptin 100 mg
    Number of subjects included in analysis
    739
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 2.48

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    377
    378
    Units: milligram(s)/decilitre
    arithmetic mean (standard deviation)
        Baseline
    9.42 ( 2.639 )
    9.09 ( 2.423 )
        Change at week 52
    -1.72 ( 2.452 )
    -0.19 ( 2.881 )
    Statistical analysis title
    		 Week 52: Change From Baseline in FPG
    Comparison groups
    Canagliflozin 300 mg v Sitagliptin 100 mg
    Number of subjects included in analysis
    755
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.658
         upper limit
    		 -1.012

    Secondary: Percent Change From Baseline in Body Weight at Week 52

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    End point title
    		 Percent Change From Baseline in Body Weight at Week 52
    End point description
    Here 'n' signifies the number of participants analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    377
    378
    Units: percentage change
    arithmetic mean (standard deviation)
        Baseline (n= 375, 367)
    87.58 ( 23.159 )
    89.61 ( 23.147 )
        Percentage change at week 52 (n= 375, 367)
    -2.6 ( 3.7 )
    0.2 ( 3.6 )
    Statistical analysis title
    		 Week 52: Percent Change in Body Weight
    Comparison groups
    Canagliflozin 300 mg v Sitagliptin 100 mg
    Number of subjects included in analysis
    755
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -2.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3

    Secondary: Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

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    End point title
    		 Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    375
    367
    Units: millimeter of mercury (mm Hg)
        least squares mean (standard error)
    -5.06 ( 0.656 )
    0.85 ( 0.666 )
    Statistical analysis title
    		 Week 52: Change From Baseline in SBP
    Comparison groups
    Canagliflozin 300 mg v Sitagliptin 100 mg
    Number of subjects included in analysis
    742
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -5.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.642
         upper limit
    		 -4.175
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.883

    Secondary: Percent Change From Baseline in Triglycerides at Week 52

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    End point title
    		 Percent Change From Baseline in Triglycerides at Week 52
    End point description
    Here 'n' signifies the number of participants analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    377
    378
    Units: Percentage change
    arithmetic mean (standard deviation)
        Baseline (n= 365, 353)
    2.06 ( 1.389 )
    1.9 ( 1.327 )
        Percentage change from Baseline (n = 365, 353)
    7.8 ( 60.6 )
    11.6 ( 44.1 )
    Statistical analysis title
    		 Week 52: Percent Change in Triglycerides
    Comparison groups
    Canagliflozin 300 mg v Sitagliptin 100 mg
    Number of subjects included in analysis
    755
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.554
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 5.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.9

    Secondary: Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52

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    End point title
    		 Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52
    End point description
    Here 'n' signifies the number of participants analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Number of subjects analysed
    377
    378
    Units: percentage change
    arithmetic mean (standard deviation)
        Baseline (n = 364, 353)
    1.18 ( 0.308 )
    1.18 ( 0.308 )
        Percentage change from baseline (n = 364, 353)
    8.2 ( 16.9 )
    1.3 ( 17.2 )
    Statistical analysis title
    		 Week 52: Percent Change in HDL-C
    Comparison groups
    Canagliflozin 300 mg v Sitagliptin 100 mg
    Number of subjects included in analysis
    755
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least-Squares Mean Difference
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 9.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline upto 30 days after the last dose of study drug (Week 52) or early withdrawal
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Canagliflozin 300 mg
    Reporting group description
    		 Canagliflozin 300 milligram (mg) capsule once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.

    Reporting group title
    Sitagliptin 100 mg
    Reporting group description
    		 Sitagliptin 100 mg capsule orally once daily for 52 weeks along with protocol-specified doses of metformin and sulphonylurea.

    Serious adverse events
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 377 (6.37%)
    21 / 378 (5.56%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer stage unspecified
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial thrombosis limb
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         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
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 377 (0.53%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory arrest
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 377 (0.53%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         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 / 377 (0.00%)
    2 / 378 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder oedema
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (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
    Leukocytoclastic vasculitis
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (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
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (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
    Bronchopneumonia
         subjects affected / exposed
    1 / 377 (0.27%)
    0 / 378 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 377 (0.00%)
    2 / 378 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    0 / 377 (0.00%)
    1 / 378 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Canagliflozin 300 mg Sitagliptin 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    157 / 377 (41.64%)
    159 / 378 (42.06%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    29 / 377 (7.69%)
    27 / 378 (7.14%)
         occurrences all number
    46
    32
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    17 / 377 (4.51%)
    26 / 378 (6.88%)
         occurrences all number
    21
    32
    Infections and infestations
    Influenza
         subjects affected / exposed
    22 / 377 (5.84%)
    15 / 378 (3.97%)
         occurrences all number
    26
    21
    Nasopharyngitis
         subjects affected / exposed
    33 / 377 (8.75%)
    38 / 378 (10.05%)
         occurrences all number
    40
    44
    Upper respiratory tract infection
         subjects affected / exposed
    33 / 377 (8.75%)
    21 / 378 (5.56%)
         occurrences all number
    38
    28
    Urinary tract infection
         subjects affected / exposed
    15 / 377 (3.98%)
    19 / 378 (5.03%)
         occurrences all number
    16
    21
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    66 / 377 (17.51%)
    75 / 378 (19.84%)
         occurrences all number
    223
    259

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2010
    The overall reason for the amendment was to modify the exclusion criterion for the estimated glomerular filtration rate (eGFR) in order to expand participant eligibility yet remain consistent with the use of metformin per the local label.

    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
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