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    Clinical Trial Results:
    Dipeptidyl peptidase-4 Inhibition and Narrow-band Ultraviolet-B light in Psoriasis (DINUP): A Randomised Clinical Trial.

    Summary
    EudraCT number
    		 2012-005483-10
    Trial protocol
    		 IE  
    Global end of trial date
    01 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Aug 2019
    First version publication date
    25 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DPIP-2012-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College Dublin
    Sponsor organisation address
    Catherine McAuley Centre, 21 Nelson Street, Dublin, Ireland,
    Public contact
    UCD Clinical Research Centre, University College Dublin, 353 17164593, rabia.hussain@ucd.ie
    Scientific contact
    UCD Clinical Research Centre, University College Dublin, 353 17164593, rabia.hussain@ucd.ie
    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
    02 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the research project is to determine the change in the psoriasis area and severity index (∆PASI) during twenty four weeks of treatment with a dipeptidyl peptidase-4 inhibitor (Januvia®, 100mg daily, or 50mg daily for participants with moderate kidney disease) in psoriasis patients undergoing narrow-band ultraviolet-B (NB-UVB) light therapy. This will be compared to the ∆PASI of psoriasis patients undergoing NB-UVB light therapy who are allocated randomly to not receive any additional treatment.
    Protection of trial subjects
    Comprehensive assessments of any apparent toxicity experienced by the research participant will be performed throughout the course of the study from the time of participant’s signature of informed consent. The safety of the investigational medicinal products will be assessed through the recording, reporting and analysing of baseline medical conditions, adverse events, vital signs and laboratory tests. If a participant is noted to score greater than 8 (out of 21) on either the anxiety or the depression components of the HADS, at this or any subsequent study visits, their GP will be advised of this and of the high likelihood of depressive/affective mental illness which may require treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 Psoriasis is a chronic, autoimmune skin disease affecting approximately 2% of the world’s population. It is characterised by keratinocyte hyperproliferation, by aberrant keratinocyte differentiation and by cutaneous inflammation. DPP-4 is expressed on keratinocytes and its activity is upregulated in psoriasis. DPP-4 inhibition suppresses keratinocyte proliferation and restores partially keratinocyte differentiation. Sitagliptin, a DPP-4 inhibitor, is an oral glucose-lowering agent approved for the treatment of type 2 diabetes mellitus. DPP-4 inhibitors prevent the degradation of insulin secretagogues such as glucagon-like peptide-1 thereby ameliorating hyperglycaemia without causing hypoglycaemia. DPP-4 inhibition may have systemic anti-inflammatory effects and a reduction in serum C-reactive protein. This randomised controlled trial assessed the effects of the DPP-4 inhibitor sitagliptin on psoriasis severity, psychological morbidity, cardiovascular disease risk factor profiles and immune parameters.
    Actual start date of recruitment
    01 Jul 2013
    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
    Ireland: 118
    Worldwide total number of subjects
    118
    EEA total number of subjects
    118
    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)
    110
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All research participants were recruited from St Vincent’s University Hospital, Elm Park, Dublin 4. Psoriasis outpatients attending the dermatology clinic who had a psoriasis area and severity index greater than 7 and who were due to undergo NB-UVB light therapy were invited to the screening visit by letter of invitation or during a clinic visit

    Pre-assignment
    Screening details
    		 Potentially eligible research participants were identified through use of patient databases in St Vincent’s University Hospital and through review of healthcare records in St Vincent’s University Hospital

    Period 1
    Period 1 title
    Baseline Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sitagliptin
    Arm description
    		 Subjects are given the DPP4 inhibitor sitagliptin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 x 50 mg daily (50 mg/day) for subjects with CrCl < 50 ml/min or eGFR < 50 ml/min/1.73m2 2 x 50 mg daily (100 mg/day) for subjects with CrCl ≥ 50 ml/min or eGFR ≥ 50 ml/min/1.73m2

    Arm title
    		 No drugs
    Arm description
    		 No drugs were given to subjects
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Sitagliptin No drugs
    Started
    60
    58
    Completed
    60
    58
    Period 2
    Period 2 title
    Trial period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sitagliptin
    Arm description
    		 Subjects are given the DPP4 inhibitor sitagliptin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 x 50 mg daily (50 mg/day) for subjects with CrCl < 50 ml/min or eGFR < 50 ml/min/1.73m2 2 x 50 mg daily (100 mg/day) for subjects with CrCl ≥ 50 ml/min or eGFR ≥ 50 ml/min/1.73m2

    Arm title
    		 No drugs
    Arm description
    		 No drugs were given to subjects
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Sitagliptin No drugs
    Started
    60
    58
    Completed
    48
    43
    Not completed
    12
    15
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    2
    1
         Lost to follow-up
    6
    9
         Lack of efficacy
    -
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Subjects are given the DPP4 inhibitor sitagliptin

    Reporting group title
    No drugs
    Reporting group description
    		 No drugs were given to subjects

    Reporting group values
    		 Sitagliptin No drugs Total
    Number of subjects
    		 60 58 118
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.86 ( 13.52 ) 44.74 ( 13.63 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 15 39
        Male
    		 36 43 79
    Ethnicity
    Units: Subjects
        Caucasian
    		 60 56 116
        African
    		 0 1 1
        East Asian
    		 0 1 1
    Smoker
    Units: Subjects
        Former
    		 23 27 50
        Current
    		 15 23 38
        Never
    		 22 7 29
        Unknown
    		 0 1 1
    Previous NB-UVB phototherapy
    Units: Subjects
        No
    		 32 28 60
        Yes
    		 28 29 57
        Unknown
    		 0 1 1
    Previous PUVA phototherapy
    Units: Subjects
        No
    		 52 53 105
        Yes
    		 8 5 13
    Chronic kidney disease stage
    Units: Subjects
        Stage 1
    		 42 33 75
        Stage 2
    		 17 20 37
        Stage 3a
    		 0 3 3
        Unknown
    		 1 2 3
    Currently using a topical psoriasis therapy
    Units: Subjects
        Yes
    		 40 30 70
        No
    		 19 28 47
        Unknown
    		 1 0 1
    Previous use of psoriasis systemic medication
    Units: Subjects
        No
    		 56 51 107
        Yes
    		 4 7 11
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.89 ( 16.28 ) 81.28 ( 15.81 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 173.1 ( 8.3 ) 172.9 ( 8.9 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.0 ( 5.3 ) 27.2 ( 4.8 ) -
    Duration of psoriasis
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 15.0 (6.0 to 20.8) 20.0 (8.0 to 32.8) -
    PASI score
    Units: score
        arithmetic mean (standard deviation)
    		 9.4 ( 2.9 ) 10.0 ( 3.1 ) -
    Body surface area
    Units: percent
        median (inter-quartile range (Q1-Q3))
    		 9 (7 to 14) 10 (8 to 16) -
    Total number of NB-UVB exposures
    Units: exposures
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 24) 0 (0 to 44) -
    Cumulative NB-UVB dose
    Units: mJ/cm2
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 19446) 0 (0 to 40983) -
    Total number of PUVA exposures
    Units: exposures
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 0) -
    Cumulative PUVA dose
    Units: J/cm2
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 0) -
    Alcohol consumption
    Units: units
        median (inter-quartile range (Q1-Q3))
    		 6 (2 to 12) 6 (2 to 12) -
    DLQI score
    Units: score
        arithmetic mean (standard deviation)
    		 9 ( 6 ) 10 ( 6 ) -
    HADS anxiety score
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 4 (3 to 7) 7 (5 to 9) -
    HADS depression score
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 3 (1 to 5) 3 (1 to 5) -
    HAQ-8 score
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 0.00 (0.00 to 0.00) 0.00 (0.00 to 0.00) -
    EQ-5D-3L utility score
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 0.850 (0.730 to 1.000) 0.830 (0.740 to 1.000) -
    EQ-5D VAS score
    Units: score
        arithmetic mean (standard deviation)
    		 74 ( 17 ) 75 ( 17 ) -
    Sitting diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 83 ( 12 ) 83 ( 10 ) -
    Sitting systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 134 ( 17 ) 133 ( 13 ) -
    Pulse
    Units: bpm
        arithmetic mean (standard deviation)
    		 72 ( 12 ) 72 ( 14 ) -
    White Blood Cells
    Units: 10^9/L
        arithmetic mean (standard deviation)
    		 6.8 ( 3.4 ) 6.9 ( 1.9 ) -
    Platelets
    Units: 10^9/L
        arithmetic mean (standard deviation)
    		 252 ( 53 ) 245 ( 60 ) -
    Haemoglobin
    Units: g/dL
        arithmetic mean (standard deviation)
    		 14.7 ( 1.3 ) 15.2 ( 1.0 ) -
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 35 ( 5 ) 36 ( 4 ) -
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 4.9 ( 0.6 ) 5.0 ( 0.6 ) -
    Cholesterol
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 5.0 ( 1.0 ) 5.1 ( 1.0 ) -
    HDL
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 1.57 ( 0.61 ) 1.50 ( 0.50 ) -
    LDL
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 2.91 ( 0.88 ) 2.96 ( 0.92 ) -
    Triglycerides
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 1.25 ( 0.62 ) 1.42 ( 0.80 ) -
    Creatinine
    Units: µmol/L
        arithmetic mean (standard deviation)
    		 74 ( 13 ) 77 ( 11 ) -
    C-reactive protein
    Units: mg/L
        arithmetic mean (standard deviation)
    		 7.3 ( 24.6 ) 3.4 ( 4.8 ) -
    ALT
    Units: U/L
        arithmetic mean (standard deviation)
    		 26 ( 15 ) 27 ( 13 ) -

    End points

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    End points reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Subjects are given the DPP4 inhibitor sitagliptin

    Reporting group title
    No drugs
    Reporting group description
    		 No drugs were given to subjects
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Subjects are given the DPP4 inhibitor sitagliptin

    Reporting group title
    No drugs
    Reporting group description
    		 No drugs were given to subjects

    Primary: Difference in PASI scores at 24 weeks

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    End point title
    		 Difference in PASI scores at 24 weeks
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: score
        arithmetic mean (confidence interval 95%)
    3.7 (3.0 to 4.3)
    4.7 (4.0 to 5.5)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0

    Secondary: Difference in PASI scores at 36 weeks

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    End point title
    		 Difference in PASI scores at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: score
        arithmetic mean (confidence interval 95%)
    4.6 (3.9 to 5.3)
    5.9 (4.9 to 6.8)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.091
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 0.2

    Secondary: Difference in DLQI scores at 24 weeks

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    End point title
    		 Difference in DLQI scores at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: change from baseline score
        arithmetic mean (confidence interval 95%)
    -6 (-8 to -5)
    -6 (-8 to -4)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.238
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 1

    Secondary: Difference in DLQI scores at 36 weeks

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    End point title
    		 Difference in DLQI scores at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: difference from baseline score
        arithmetic mean (confidence interval 95%)
    -5 (-7 to -3)
    -5 (-7 to -3)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.383
    Method
    		 Regression, Linear
    Parameter type
    		 Median difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 1

    Secondary: Difference in HADS scores at 24 weeks

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    End point title
    		 Difference in HADS scores at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: score
        arithmetic mean (confidence interval 95%)
    5 (4 to 6)
    8 (6 to 9)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 -1

    Secondary: Difference in HADS scores at 36 weeks

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    End point title
    		 Difference in HADS scores at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: score
        arithmetic mean (confidence interval 95%)
    5 (3 to 6)
    8 (7 to 10)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Regression, Linear
    Parameter type
    		 Median difference (net)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 -1

    Secondary: Difference in EQ-5D scores at 24 weeks

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    End point title
    		 Difference in EQ-5D scores at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: change from baseline score
        arithmetic mean (confidence interval 95%)
    0.108 (0.057 to 0.159)
    0.045 (-0.018 to 0.108)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.061
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.005
         upper limit
    		 0.117

    Secondary: Difference in EQ-5D scores at 36 weeks

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    End point title
    		 Difference in EQ-5D scores at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: change from baseline score
        arithmetic mean (confidence interval 95%)
    0.083 (0.020 to 0.145)
    -0.016 (-0.096 to 0.064)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    No drugs v Sitagliptin
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.096
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.015
         upper limit
    		 0.178

    Secondary: Difference in Visual Analogue Scale scores at 24 weeks

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    End point title
    		 Difference in Visual Analogue Scale scores at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: score
        arithmetic mean (confidence interval 95%)
    81 (77 to 85)
    84 (81 to 87)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.269
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 2

    Secondary: Difference in Visual Analogue Scale scores at 36 weeks

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    End point title
    		 Difference in Visual Analogue Scale scores at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: score
        arithmetic mean (confidence interval 95%)
    78 (74 to 83)
    79 (73 to 84)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.939
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 7

    Secondary: Difference in HAQ-8 scores at 24 weeks

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    End point title
    		 Difference in HAQ-8 scores at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: change from baseline score
        arithmetic mean (confidence interval 95%)
    -0.01 (-0.07 to 0.05)
    0.07 (0.01 to 0.14)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.229
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.04

    Secondary: Difference in HAQ-8 scores at 36 weeks

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    End point title
    		 Difference in HAQ-8 scores at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: change from baseline score
        arithmetic mean (confidence interval 95%)
    -0.01 (-0.04 to 0.01)
    0.04 (0.00 to 0.08)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.172
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.01

    Secondary: Difference in cumulative narrow-band UVB dose by 36 weeks

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    End point title
    		 Difference in cumulative narrow-band UVB dose by 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: natural log transformed cumulative dose
        arithmetic mean (confidence interval 95%)
    10.036 (9.873 to 10.199)
    10.102 (9.911 to 10.293)
    Statistical analysis title
    		 Difference log means adjusted to baseline measure
    Comparison groups
    No drugs v Sitagliptin
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 Lognormal regression
    Parameter type
    		 Log mean difference
    Point estimate
    -0.044
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.308
         upper limit
    		 0.22

    Secondary: Difference in number of narrow-band UVB exposures by 36 weeks

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    End point title
    		 Difference in number of narrow-band UVB exposures by 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: exposures
        arithmetic mean (confidence interval 95%)
    28 (27 to 29)
    27 (26 to 28)
    Statistical analysis title
    		 Incident rate ratio
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.307
    Method
    		 Poisson regression
    Parameter type
    		 Incident rate ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.12

    Secondary: Proportion of cases that reach PASI-50 by 36 weeks

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    End point title
    		 Proportion of cases that reach PASI-50 by 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    48
    43
    Units: cases that reach PASI-50 by 36 weeks
    22
    18
    Statistical analysis title
    		 Difference in proportions
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.703
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 2.7

    Secondary: Proportion of cases that reach PASI-75 by 36 weeks

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    End point title
    		 Proportion of cases that reach PASI-75 by 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    48
    43
    Units: cases that reach PASI-75 by 36 weeks
    13
    4
    Statistical analysis title
    		 Difference in proportions
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 12.14

    Secondary: Proportion of cases that relapse (PASI greater than 50% of original value) within 36 weeks

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    End point title
    		 Proportion of cases that relapse (PASI greater than 50% of original value) within 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    46
    42
    Units: cases that relapse
    27
    26
    Statistical analysis title
    		 Difference in proportions
    Comparison groups
    No drugs v Sitagliptin
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.759
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 2.06

    Secondary: Time taken to achieve PASI-50

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    End point title
    		 Time taken to achieve PASI-50
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    57
    Units: weeks
        median (confidence interval 95%)
    6.29 (5.86 to 10.57)
    6.29 (6.00 to 11.29)
    Statistical analysis title
    		 Difference in hazard rate
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.361
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.75

    Secondary: Time taken to achieve PASI-75

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    End point title
    		 Time taken to achieve PASI-75
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    57
    Units: weeks
        median (confidence interval 95%)
    12.86 (11.86 to 99999999)
    13.14 (12.14 to 99999999)
    Statistical analysis title
    		 Difference in hazard rate
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.443
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.94

    Secondary: Difference in systolic blood pressure at 24 weeks

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    End point title
    		 Difference in systolic blood pressure at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    130 (126 to 133)
    129 (126 to 132)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.912
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.29
         upper limit
    		 3.84

    Secondary: Difference in systolic blood pressure at 36 weeks

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    End point title
    		 Difference in systolic blood pressure at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    131 (128 to 134)
    132 (128 to 135)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.426
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.66
         upper limit
    		 2.45

    Secondary: Difference in diastolic blood pressure at 24 weeks

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    End point title
    		 Difference in diastolic blood pressure at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    80 (77 to 83)
    81 (78 to 83)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.683
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.11
         upper limit
    		 2.72

    Secondary: Difference in diastolic blood pressure at 36 weeks

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    End point title
    		 Difference in diastolic blood pressure at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    81 (79 to 83)
    82 (79 to 85)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.417
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.14
         upper limit
    		 1.75

    Secondary: Difference in pulse at 24 weeks

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    End point title
    		 Difference in pulse at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: bpm
        arithmetic mean (confidence interval 95%)
    73 (70 to 76)
    70 (67 to 74)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    No drugs v Sitagliptin
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.318
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 6

    Secondary: Difference in pulse at 36 weeks

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    End point title
    		 Difference in pulse at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: bpm
        arithmetic mean (confidence interval 95%)
    76 (72 to 79)
    72 (68 to 75)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.074
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 8

    Secondary: Difference in LDL cholesterol at 24 weeks

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    End point title
    		 Difference in LDL cholesterol at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    2.85 (2.63 to 3.07)
    2.95 (2.70 to 3.19)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.649
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.16

    Secondary: Difference in LDL cholesterol at 36 weeks

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    End point title
    		 Difference in LDL cholesterol at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    2.86 (2.63 to 3.09)
    2.95 (2.72 to 3.18)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.756
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.2

    Secondary: Difference in HDL cholesterol at 24 weeks

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    End point title
    		 Difference in HDL cholesterol at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    1.60 (1.46 to 1.74)
    1.50 (1.36 to 1.63)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.688
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.14

    Secondary: Difference in HDL cholesterol at 36 weeks

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    End point title
    		 Difference in HDL cholesterol at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    1.65 (1.48 to 1.82)
    1.49 (1.35 to 1.63)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.39
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.26

    Secondary: Difference in triglycerides at 24 weeks

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    End point title
    		 Difference in triglycerides at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    1.14 (0.99 to 1.29)
    1.37 (1.16 to 1.59)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.1

    Secondary: Difference in triglycerides at 36 weeks

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    End point title
    		 Difference in triglycerides at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    1.27 (1.10 to 1.44)
    1.39 (1.21 to 1.58)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.875
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.19

    Secondary: Difference in glucose at 24 weeks

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    End point title
    		 Difference in glucose at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    4.9 (4.7 to 5.0)
    5.0 (4.8 to 5.2)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.463
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.1

    Secondary: ifference in glucose at 36 weeks

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    End point title
    		 ifference in glucose at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    57
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    5.1 (4.7 to 5.4)
    4.9 (4.7 to 5.0)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.201
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.6

    Secondary: Difference in HbA1c at 24 weeks

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    End point title
    		 Difference in HbA1c at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/mol
        arithmetic mean (confidence interval 95%)
    34 (33 to 35)
    36 (35 to 37)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0

    Secondary: Difference in HbA1c at 36 weeks

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    End point title
    		 Difference in HbA1c at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mmol/mol
        arithmetic mean (confidence interval 95%)
    34 (33 to 36)
    35 (34 to 36)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1

    Secondary: Difference in haemoglobin at 24 weeks

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    End point title
    		 Difference in haemoglobin at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: g/dL
        arithmetic mean (confidence interval 95%)
    14.5 (14.2 to 14.8)
    15.0 (14.7 to 15.3)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.483
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.2

    Secondary: Difference in haemoglobin at 36 weeks

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    End point title
    		 Difference in haemoglobin at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: g/dL
        arithmetic mean (confidence interval 95%)
    14.6 (14.3 to 15.0)
    15.0 (14.7 to 15.3)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.628
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.4

    Secondary: Difference in creatinine at 24 weeks

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    End point title
    		 Difference in creatinine at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: µmol/L
        arithmetic mean (confidence interval 95%)
    76 (72 to 80)
    76 (73 to 79)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.168
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 5

    Secondary: Difference in creatinine at 36 weeks

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    End point title
    		 Difference in creatinine at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: µmol/L
        arithmetic mean (confidence interval 95%)
    74 (71 to 77)
    77 (74 to 80)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.269
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 1

    Secondary: Difference in white blood cell count at 24 weeks

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    End point title
    		 Difference in white blood cell count at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: 10^9/L
        arithmetic mean (confidence interval 95%)
    6.8 (6.2 to 7.4)
    6.5 (5.9 to 7.0)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.232
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.9

    Secondary: Difference in white blood cell count at 36 weeks

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    End point title
    		 Difference in white blood cell count at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: 10^9/L
        arithmetic mean (confidence interval 95%)
    6.4 (5.7 to 7.2)
    6.9 (6.3 to 7.5)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.221
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.3

    Secondary: Difference in platelet count at 24 weeks

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    End point title
    		 Difference in platelet count at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: 10^9/L
        arithmetic mean (confidence interval 95%)
    242 (229 to 254)
    245 (230 to 260)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.305
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19
         upper limit
    		 6

    Secondary: Difference in platelet count at 36 weeks

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    End point title
    		 Difference in platelet count at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: 10^9/L
        arithmetic mean (confidence interval 95%)
    252 (238 to 266)
    246 (228 to 264)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.779
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 19

    Secondary: Difference in C-reactive protein at 24 weeks

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    End point title
    		 Difference in C-reactive protein at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mg/L
        arithmetic mean (confidence interval 95%)
    2.9 (2.1 to 3.7)
    2.8 (2.1 to 3.5)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.748
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 1.3

    Secondary: Difference in C-reactive protein at 36 weeks

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    End point title
    		 Difference in C-reactive protein at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: mg/L
        arithmetic mean (confidence interval 95%)
    3.1 (2.0 to 4.2)
    5.9 (0.8 to 11.0)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.288
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 2.4

    Secondary: Difference in ALT at 24 weeks

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    End point title
    		 Difference in ALT at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: U/L
        arithmetic mean (confidence interval 95%)
    25 (21 to 29)
    27 (24 to 30)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    Sitagliptin v No drugs
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 2

    Secondary: Difference in ALT at 36 weeks

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    End point title
    		 Difference in ALT at 36 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    36 weeks
    End point values
    		 Sitagliptin No drugs
    Number of subjects analysed
    60
    58
    Units: U/L
        arithmetic mean (confidence interval 95%)
    27 (21 to 32)
    29 (22 to 37)
    Statistical analysis title
    		 Difference in means adjusted to baseline measure
    Comparison groups
    No drugs v Sitagliptin
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.709
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored during 36 weeks of the study and reported at each scheduled and unscheduled study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Subjects are given the DPP4 inhibitor sitagliptin

    Reporting group title
    No drugs
    Reporting group description
    		 No drugs were given to subjects

    Serious adverse events
    		 Sitagliptin No drugs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    6 / 58 (10.34%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Ovariectomy
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    CVA
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         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 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Postoperative bleeding
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         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: 0%
    Non-serious adverse events
    		 Sitagliptin No drugs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 60 (86.67%)
    47 / 58 (81.03%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian cyst
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Premalignant skin lesion
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Cystocele repair
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Hip replacement
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Tonsillectomy
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Tooth extraction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Per vaginal bleeding
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    Sore throat
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    2
    Depression
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Knee injury
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    2
    Cardiac disorders
    Hypercholesterolaemia
         subjects affected / exposed
    9 / 60 (15.00%)
    11 / 58 (18.97%)
         occurrences all number
    9
    12
    Hypertension
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    Vasovagal symptoms
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    Lightheadedness
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Paresthesia upper limb
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Hemoglobin increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Platelets decreased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Earache
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 58 (3.45%)
         occurrences all number
    5
    2
    C.difficile colitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    Gastroesophageal reflux
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
         occurrences all number
    1
    2
    Rectal bleeding
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Elevated triglycerides
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    2
    Fatty liver
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Liver enzyme abnormal
         subjects affected / exposed
    2 / 60 (3.33%)
    5 / 58 (8.62%)
         occurrences all number
    2
    5
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    9 / 60 (15.00%)
    18 / 58 (31.03%)
         occurrences all number
    12
    22
    Hematoma
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Polymorphic light eruption
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 58 (3.45%)
         occurrences all number
    2
    2
    Rash
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Creatinine increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Renal function abnormal
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Urine colour abnormal
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Blood glucose increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Diabetes mellitus
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Back injury
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    Cervical radiculopathy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Compound fracture - tibia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Foot pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Fracture
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Fractured ribs
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Knee pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Lateral epicondylitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Shoulder pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess breast
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Dental abscess
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Flu-like symptoms
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
         occurrences all number
    1
    2
    Herpes Simplex Virus
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    Herpes zoster
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Insect bite NOS
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 60 (6.67%)
    5 / 58 (8.62%)
         occurrences all number
    4
    5
    Pharyngitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 58 (3.45%)
         occurrences all number
    4
    2
    Skin and soft tissue infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Throat infection
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    Tinea corporis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    Tooth abscess
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 60 (20.00%)
    11 / 58 (18.97%)
         occurrences all number
    13
    13
    Urinary tract infections
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    Viral gastroenteritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26767505
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