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    Clinical Trial Results:
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK8835/PF04971729) in the Treatment of Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

    Summary
    EudraCT number
    		 2013-003697-26
    Trial protocol
    		 CZ   SK   FI   BG   HU  
    Global end of trial date
    06 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2017
    First version publication date
    04 Jun 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    8835-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02036515
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Pfizer Protocol Number: B1521015
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    06 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a safety and efficacy study of ertugliflozin (MK8835/PF04971729) in the treatment of participants withtype 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C) lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5mg and 15mg doses of ertugliflozin.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure(s) defined for this individual study was (were) in place for the protection of trial subjects: During the double-blind treatment period, participants who met progressively more stringent glycemic rescue criteria were to receive open-label glimepiride rescue medication. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol-specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Mar 2014
    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
    Argentina: 16
    Country: Number of subjects enrolled
    Bulgaria: 32
    Country: Number of subjects enrolled
    Colombia: 17
    Country: Number of subjects enrolled
    Czech Republic: 48
    Country: Number of subjects enrolled
    Finland: 27
    Country: Number of subjects enrolled
    Hungary: 27
    Country: Number of subjects enrolled
    Israel: 35
    Country: Number of subjects enrolled
    Korea, Republic of: 63
    Country: Number of subjects enrolled
    Malaysia: 30
    Country: Number of subjects enrolled
    Romania: 39
    Country: Number of subjects enrolled
    Slovakia: 36
    Country: Number of subjects enrolled
    United States: 94
    Worldwide total number of subjects
    464
    EEA total number of subjects
    209
    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)
    326
    From 65 to 84 years
    138
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Two participants were randomized to Ertugliflozin 15 mg, but did not receive any treatment.

    Period 1
    Period 1 title
    Randomization period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ertugliflozin 5 mg
    Arm description
    		 Ertugliflozin, 5 mg, oral, once daily for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ertugliflozin 5 mg
    Investigational medicinal product code
    Other name
    MK-8835 PF-04971729
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Amaryl
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator’s discretion

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Lantus
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

    Arm title
    		 Ertugliflozin 15 mg
    Arm description
    		 Ertugliflozin, 15 mg, oral, once daily for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ertugliflozin 5 mg
    Investigational medicinal product code
    Other name
    MK-8835 PF-04971729
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks

    Investigational medicinal product name
    Ertugliflozin 10 mg
    Investigational medicinal product code
    Other name
    MK-8835 PF-04971729
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, oral, 10 mg tablet once daily for 52 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Glucophage Glucophage XR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Amaryl
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator’s discretion

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Lantus
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo to ertuglifozin, oral, once daily for 52 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to ertugliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to ertugliflozin 5 mg and 10 mg once daily for 52 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Glucophage Glucophage XR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Amaryl
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator’s discretion

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Lantus
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

    Number of subjects in period 1
    		Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Started
    156
    155
    153
    Completed
    156
    153
    153
    Not completed
    0
    2
    0
         Screen failure
    -
    2
    -
    Period 2
    Period 2 title
    52-week treatment period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ertugliflozin 5 mg
    Arm description
    		 Ertugliflozin, 5 mg, oral, once daily for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ertugliflozin 5 mg
    Investigational medicinal product code
    Other name
    MK-8835 PF-04971729
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Amaryl
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator’s discretion

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Lantus
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

    Arm title
    		 Ertugliflozin 15 mg
    Arm description
    		 Ertugliflozin, 15 mg, oral, once daily for 52 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ertugliflozin 5 mg
    Investigational medicinal product code
    Other name
    MK-8835 PF-04971729
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks

    Investigational medicinal product name
    Ertugliflozin 10 mg
    Investigational medicinal product code
    Other name
    MK-8835 PF-04971729
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, oral, 10 mg tablet once daily for 52 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Glucophage Glucophage XR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Amaryl
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator’s discretion

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Lantus
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo to ertuglifozin, oral, once daily for 52 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to ertugliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to ertugliflozin 5 mg and 10 mg once daily for 52 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Glucophage Glucophage XR
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Amaryl
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator’s discretion

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Lantus
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine may have been initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The baseline period (52-week treatment period) consists of participants who received at least one dose of study medication. Period 1 includes 2 participants who were randomized but not treated.
    Number of subjects in period 2 [2]
    		Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Started
    156
    153
    153
    Completed
    151
    143
    139
    Not completed
    5
    10
    14
         Consent withdrawn by subject
    4
    7
    9
         Adverse event, non-fatal
    1
    1
    2
         Non-compliance with study drug
    -
    -
    2
         Lost to follow-up
    -
    2
    -
         Hyperglycemia
    -
    -
    1
    Notes
    [2] - 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: The worldwide number of subjects enrolled in the study includes 2 participants who were randomized but not treated. The baseline period (52-week treatment period) consists of participants who received at least one dose of study medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ertugliflozin 5 mg
    Reporting group description
    		 Ertugliflozin, 5 mg, oral, once daily for 52 weeks

    Reporting group title
    Ertugliflozin 15 mg
    Reporting group description
    		 Ertugliflozin, 15 mg, oral, once daily for 52 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to ertuglifozin, oral, once daily for 52 weeks

    Reporting group values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo Total
    Number of subjects
    		 156 153 153 462
    Age categorical
    Units: Subjects
        <45 years
    		 10 9 15 34
        45 to 64 years
    		 97 102 91 290
        65 years and older
    		 49 42 47 138
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.2 ± 9.3 59.7 ± 8.6 58.3 ± 9.2 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 75 71 53 199
        Male
    		 81 82 100 263
    Study Specific Characteristic | Hemoglobin A1c (A1C)
    Participants with baseline data: ertugliflozin 5 mg, n=155; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=459
    Units: Percent
        arithmetic mean (standard deviation)
    		 8.05 ± 0.86 8 ± 0.83 8.03 ± 0.93 -
    Study Specific Characteristic | Fasting plasma glucose
    Participants with baseline data: ertugliflozin 5 mg, n=156; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=460
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 167.7 ± 37.7 171.7 ± 39.1 169.6 ± 37.8 -
    Study Specific Characteristic | Body weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    		 87.6 ± 18.6 86.6 ± 19.5 86.4 ± 20.8 -
    Study Specific Characteristic | Estimated glomerular filtration rate (eGFR)
    Units: mL/min/1.73m^2
        arithmetic mean (standard deviation)
    		 87 ± 17.5 86.9 ± 15.6 89.9 ± 17.5 -

    End points

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    End points reporting groups
    Reporting group title
    Ertugliflozin 5 mg
    Reporting group description
    		 Ertugliflozin, 5 mg, oral, once daily for 52 weeks

    Reporting group title
    Ertugliflozin 15 mg
    Reporting group description
    		 Ertugliflozin, 15 mg, oral, once daily for 52 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to ertuglifozin, oral, once daily for 52 weeks
    Reporting group title
    Ertugliflozin 5 mg
    Reporting group description
    		 Ertugliflozin, 5 mg, oral, once daily for 52 weeks

    Reporting group title
    Ertugliflozin 15 mg
    Reporting group description
    		 Ertugliflozin, 15 mg, oral, once daily for 52 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to ertuglifozin, oral, once daily for 52 weeks

    Primary: Change from baseline in hemoglobin A1C at Week 26

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    End point title
    		 Change from baseline in hemoglobin A1C at Week 26
    End point description
    A1C is measured as percent. Thus this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
    End point type
    Primary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.78 (-0.91 to -0.65)
    -0.86 (-0.99 to -0.72)
    -0.09 (-0.23 to -0.04)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [1]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 -0.5
    Notes
    [1] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [2]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares mean
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 -0.58
    Notes
    [2] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication

    Primary: Percentage of Participants Experiencing An Adverse Event (AE)

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    End point title
    		 Percentage of Participants Experiencing An Adverse Event (AE)
    End point description
    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy. Analysis population consisted of all randomized participants who took at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 54
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percentage of participants
        number (not applicable)
    57.7
    60.1
    63.4
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 5.2
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 7.6

    Primary: Percentage of Participants Discontinuing Study Treatment Due to an AE

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    End point title
    		 Percentage of Participants Discontinuing Study Treatment Due to an AE
    End point description
    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy. Analysis population consisted of all randomized participants who took at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percentage of participants
        number (not applicable)
    4.5
    3.9
    3.9
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 5.6
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 4.9

    Secondary: Change from baseline in fasting plasma glucose (FPG) at Week 26

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    End point title
    		 Change from baseline in fasting plasma glucose (FPG) at Week 26
    End point description
    The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -26.91 (-32.58 to -21.24)
    -33.04 (-38.71 to -27.36)
    -1.76 (-7.7 to 4.18)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [3]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Differenc in least squares means
    Point estimate
    -25.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.76
         upper limit
    		 -17.54
    Notes
    [3] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [4]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares means
    Point estimate
    -31.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.9
         upper limit
    		 -23.66
    Notes
    [4] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication

    Secondary: Change from baseline in body weight at Week 26

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    End point title
    		 Change from baseline in body weight at Week 26
    End point description
    The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: kg
        least squares mean (confidence interval 95%)
    -3.35 (-3.78 to -2.91)
    -3.04 (-3.48 to -2.6)
    -1.32 (-1.77 to -0.87)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [5]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares means
    Point estimate
    -2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.65
         upper limit
    		 -1.4
    Notes
    [5] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [6]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares means
    Point estimate
    -1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.35
         upper limit
    		 -1.09
    Notes
    [6] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication

    Secondary: Percentage of participants with an A1C <7% (53 mmol/mol) at Week 26

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    End point title
    		 Percentage of participants with an A1C <7% (53 mmol/mol) at Week 26
    End point description
    A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percentage of participants
        number (not applicable)
    32.1
    39.9
    17
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [7]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.74
         upper limit
    		 5.72
    Notes
    [7] - Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [8]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in least squares means
    Point estimate
    4.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.44
         upper limit
    		 8.02
    Notes
    [8] - Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.

    Secondary: Change from baseline in sitting systolic blood pressure at Week 26

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    End point title
    		 Change from baseline in sitting systolic blood pressure at Week 26
    End point description
    The change from baseline is the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: mmHg
    least squares mean (standard error)
        Baseline
    130.87 ± 0.62
    130.87 ± 0.62
    130.87 ± 0.62
        Change from baseline
    -3.81 ± 0.87
    -4.82 ± 0.88
    -0.88 ± 0.93
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.019 [9]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares means
    Point estimate
    -2.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.36
         upper limit
    		 -0.49
    Notes
    [9] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.002 [10]
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares means
    Point estimate
    -3.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.39
         upper limit
    		 -1.5
    Notes
    [10] - Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication

    Secondary: Change from baseline in hemoglobin A1C at Week 52

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    End point title
    		 Change from baseline in hemoglobin A1C at Week 52
    End point description
    A1C is measured as percent. Thus this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.75 (-0.9 to -0.59)
    -0.81 (-0.97 to -0.66)
    0.02 (-0.15 to 0.19)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 -0.54
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 -0.61

    Secondary: Change from baseline in FPG at Week 52

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    End point title
    		 Change from baseline in FPG at Week 52
    End point description
    The change from baseline is the Week 52 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -25.57 (-30.91 to -20.23)
    -26.38 (-31.8 to -20.97)
    3.19 (-3.08 to 9.47)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -28.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.44
         upper limit
    		 -21.09
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -29.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.3
         upper limit
    		 -21.85

    Secondary: Change from baseline in body weight at Week 52

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    End point title
    		 Change from baseline in body weight at Week 52
    End point description
    The change from baseline is the Week 52 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: kg
        least squares mean (confidence interval 95%)
    -3.46 (-4.07 to -2.85)
    -2.83 (-3.45 to -2.21)
    -0.95 (-1.65 to -0.26)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.43
         upper limit
    		 -1.59
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.81
         upper limit
    		 -0.95

    Secondary: Percentage of participants with an A1C <7% (53 mmol/mol) at Week 52

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    End point title
    		 Percentage of participants with an A1C <7% (53 mmol/mol) at Week 52
    End point description
    A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percentage of participants
        number (not applicable)
    33.3
    32.7
    13.7
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 6.64
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.22
         upper limit
    		 7.28

    Secondary: Change from baseline in sitting systolic blood pressure at Week 52

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    End point title
    		 Change from baseline in sitting systolic blood pressure at Week 52
    End point description
    The change from baseline is the Week 52 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: mmHg
    least squares mean (standard error)
        Baseline
    130.92 ± 0.62
    130.92 ± 0.62
    130.92 ± 0.62
        Change from baseline
    -4.16 ± 0.95
    -4.09 ± 0.96
    0.83 ± 1.14
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -4.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.82
         upper limit
    		 -2.15
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -4.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.76
         upper limit
    		 -2.07

    Secondary: Change from baseline in sitting diastolic blood pressure at Week 26

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    End point title
    		 Change from baseline in sitting diastolic blood pressure at Week 26
    End point description
    The change from baseline is the Week 26 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: mmHg
    least squares mean (standard error)
        Baseline
    78.42 ± 0.36
    78.42 ± 0.36
    78.42 ± 0.36
        Change from baseline
    -1.68 ± 0.61
    -1.81 ± 0.62
    -0.43 ± 0.65
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.97
         upper limit
    		 0.48
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.11
         upper limit
    		 0.36

    Secondary: Change from baseline in sitting diastolic blood pressure at Week 52

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    End point title
    		 Change from baseline in sitting diastolic blood pressure at Week 52
    End point description
    The change from baseline is the Week 52 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: mmHg
    least squares mean (standard error)
        Baseline
    78.44 ± 0.36
    78.44 ± 0.36
    78.44 ± 0.36
        Change from baseline
    -1.52 ± 0.61
    -1.38 ± 0.62
    -0.53 ± 0.73
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.82
         upper limit
    		 0.84
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.69
         upper limit
    		 0.99

    Secondary: Percentage of participants receiving glycemic rescue medication by Week 26

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    End point title
    		 Percentage of participants receiving glycemic rescue medication by Week 26
    End point description
    Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Analysis population included all randomized participants who took at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percentage of participants
        number (not applicable)
    1.3
    2
    16.3
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percent
    Point estimate
    -15.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.9
         upper limit
    		 -9.4
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percent
    Point estimate
    -14.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.3
         upper limit
    		 -8.5

    Secondary: Percentage of participants receiving glycemic rescue medication by Week 52

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    End point title
    		 Percentage of participants receiving glycemic rescue medication by Week 52
    End point description
    Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Analysis population included all randomized participants who took at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Percentage of participants
        number (not applicable)
    12.8
    13.7
    41.8
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.3
         upper limit
    		 -19.4
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -28.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.5
         upper limit
    		 -18.4

    Secondary: Time to initiation of glycemic rescue by Week 26

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    End point title
    		 Time to initiation of glycemic rescue by Week 26
    End point description
    Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days. Analysis population included all randomized participants who took at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Up to week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Days
        Minimum time to initiation of glycemic rescue
    135
    43
    26
        Maximum time to initiation of glycemic rescue
    141
    147
    212
    No statistical analyses for this end point

    Secondary: Time to initiation of glycemic rescue by Week 52

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    End point title
    		 Time to initiation of glycemic rescue by Week 52
    End point description
    Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days. Analysis population included all randomized participants who took at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Up to week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    156
    153
    153
    Units: Days
        Minimum time to initiation of glycemic rescue
    135
    43
    26
        Maximum time to initiation of glycemic rescue
    295
    299
    327
    No statistical analyses for this end point

    Secondary: Baseline homeostasis model assessment of β-cell function (HOMA-%β) value

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    End point title
    		 Baseline homeostasis model assessment of β-cell function (HOMA-%β) value
    End point description
    HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Analysis population included all randomized participants who took at least one dose of study medication and had HOMA-%β measurement at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    140
    131
    127
    Units: Percentage
        arithmetic mean (standard deviation)
    47.99 ± 23.89
    48.54 ± 34.782
    48.04 ± 30.733
    No statistical analyses for this end point

    Secondary: Change from baseline in HOMA-%β at Week 26

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    End point title
    		 Change from baseline in HOMA-%β at Week 26
    End point description
    HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    153
    151
    147
    Units: Percentage
        least squares mean (confidence interval 95%)
    13.28 (8.87 to 17.68)
    12.43 (7.94 to 16.93)
    0.52 (-4.08 to 5.12)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    12.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.83
         upper limit
    		 18.68
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    11.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.94
         upper limit
    		 17.88

    Secondary: Change from baseline in HOMA-%β at Week 52

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    End point title
    		 Change from baseline in HOMA-%β at Week 52
    End point description
    HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    155
    152
    152
    Units: Percentage
        least squares mean (confidence interval 95%)
    10.85 (6.29 to 15.41)
    10.93 (6.24 to 15.61)
    -1.93 (-6.88 to 3.02)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    12.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.54
         upper limit
    		 19.03
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    12.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.54
         upper limit
    		 19.18

    Secondary: Baseline EQ-5D 3-level version (EQ-5D-3L) Questionnaire Score

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    End point title
    		 Baseline EQ-5D 3-level version (EQ-5D-3L) Questionnaire Score
    End point description
    The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ visual analogue score (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Analysis population included all randomized participants who took at least one dose of study medication and had a baseline EQ-5D-3L measurement.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    150
    150
    152
    Units: Score on a scale
        arithmetic mean (standard deviation)
    0.88 ± 0.166
    0.89 ± 0.182
    0.9 ± 0.144
    No statistical analyses for this end point

    Secondary: Change from baseline in EQ-5D-3L Questionnaire Score at Week 26

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    End point title
    		 Change from baseline in EQ-5D-3L Questionnaire Score at Week 26
    End point description
    The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Decrease from baseline in EQ-5D-3L signifies improvement. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 26
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    155
    151
    153
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    0 (-0.02 to 0.03)
    0.02 (0 to 0.04)
    0.01 (-0.01 to 0.04)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.02
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.04

    Secondary: Change from baseline in EQ-5D-3L score at Week 52

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    End point title
    		 Change from baseline in EQ-5D-3L score at Week 52
    End point description
    The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Decrease from baseline in EQ-5D-3L signifies improvement. Data presented exclude data following the initiation of rescue therapy. Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
    Number of subjects analysed
    155
    151
    153
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    0.03 (0 to 0.05)
    0 (-0.03 to 0.03)
    0.02 (-0.01 to 0.06)
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 5 mg v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.04
    Statistical analysis title
    		 Between group comparison
    Comparison groups
    Ertugliflozin 15 mg v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.02

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 54 weeks
    Adverse event reporting additional description
    Data presented below includes data following the initiation of rescue therapy for the entire study (ie, all data after randomization, with no upper limit on the follow-up window for participants who discontinued study drug). Two participants randomized to ertugliflozin 15 mg didn’t receive any study medication & aren’t included in the below tables
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Ertugliflozin 5 mg (Phase A+B)
    Reporting group description
    		 Ertugliflozin, 5 mg, oral, once daily for 52 weeks

    Reporting group title
    Placebo (Phase A+B)
    Reporting group description
    		 Matching placebo to ertuglifozin, oral, once daily for 52 weeks

    Reporting group title
    Ertugliflozin 15 mg (Phase A+B)
    Reporting group description
    		 Ertugliflozin, 15 mg, oral, once daily for 52 weeks

    Serious adverse events
    		 Ertugliflozin 5 mg (Phase A+B) Placebo (Phase A+B) Ertugliflozin 15 mg (Phase A+B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 156 (8.33%)
    8 / 153 (5.23%)
    3 / 153 (1.96%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ear neoplasm
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urge incontinence
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone tuberculosis
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ertugliflozin 5 mg (Phase A+B) Placebo (Phase A+B) Ertugliflozin 15 mg (Phase A+B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 156 (15.38%)
    29 / 153 (18.95%)
    18 / 153 (11.76%)
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 156 (5.13%)
    6 / 153 (3.92%)
    3 / 153 (1.96%)
         occurrences all number
    8
    6
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 156 (5.13%)
    5 / 153 (3.27%)
    6 / 153 (3.92%)
         occurrences all number
    8
    6
    6
    Urinary tract infection
         subjects affected / exposed
    2 / 156 (1.28%)
    8 / 153 (5.23%)
    5 / 153 (3.27%)
         occurrences all number
    2
    9
    5
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    7 / 156 (4.49%)
    11 / 153 (7.19%)
    5 / 153 (3.27%)
         occurrences all number
    16
    18
    11

    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
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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