We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    VERTIS SITA2
Previous Study | Return to List | Next Study

Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036515
First Posted: January 15, 2014
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: May 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Ertugliflozin 5 mg
Drug: Ertugliflozin 15 mg
Drug: Placebo for ertugliflozin 5 mg
Drug: Metformin
Drug: Sitagliptin
Drug: Glimepiride
Biological: Insulin
Drug: Placebo for ertugliflozin 10 mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants were randomized to Ertugliflozin 15 mg, but did not receive any treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Participant Flow:   Overall Study
    Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo
STARTED   156   155   153 
Treated   156   153   153 
COMPLETED   151   143   139 
NOT COMPLETED   5   12   14 
Adverse Event                1                1                2 
Lost to Follow-up                0                2                0 
Non-compliance with study drug                0                0                2 
Screen failure                0                2                0 
Withdrawal by Subject                4                7                9 
Hyperglycemia                0                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants as treated population excludes two participants randomized to Ertugliflozin 15 mg but did not receive any treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 156   153   153   462 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.2  (9.3)   59.7  (8.6)   58.3  (9.2)   59.1  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      75  48.1%      71  46.4%      53  34.6%      199  43.1% 
Male      81  51.9%      82  53.6%      100  65.4%      263  56.9% 
Hemoglobin A1c (A1C) [1] 
[Units: Percent]
Mean (Standard Deviation)
 8.05  (0.86)   8.00  (0.83)   8.03  (0.93)   8.03  (0.88) 
[1] Participants with baseline data: ertugliflozin 5 mg, n=155; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=459
Fasting plasma glucose [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 167.7  (37.7)   171.7  (39.1)   169.6  (37.8)   169.7  (38.2) 
[1] Participants with baseline data: ertugliflozin 5 mg, n=156; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=460
Body weight 
[Units: Kilograms]
Mean (Standard Deviation)
 87.6  (18.6)   86.6  (19.5)   86.4  (20.8)   86.9  (19.6) 
Estimated glomerular filtration rate (eGFR) 
[Units: mL/min/1.73m^2]
Mean (Standard Deviation)
 87.0  (17.5)   86.9  (15.6)   89.9  (17.5)   87.9  (16.9) 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1C at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Primary
Measure Title Change From Baseline in Hemoglobin A1C at Week 26
Measure 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.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Hemoglobin A1C at Week 26 
[Units: Percent]
Least Squares Mean (95% Confidence Interval)
 -0.78 
 (-0.91 to -0.65) 
 -0.86 
 (-0.99 to -0.72) 
 -0.09 
 (-0.23 to -0.04) 


Statistical Analysis 1 for Change From Baseline in Hemoglobin A1C at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Constrained longitudinal data analysis
P Value [4] <0.001
Difference in least squares mean [5] -0.69
95% Confidence Interval -0.87 to -0.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Hemoglobin A1C at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] <0.001
Difference in least squares mean [5] -0.76
95% Confidence Interval -0.95 to -0.58
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Primary:   Percentage of Participants Experiencing An Adverse Event (AE)   [ Time Frame: Up to Week 54 ]

Measure Type Primary
Measure Title Percentage of Participants Experiencing An Adverse Event (AE)
Measure 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.
Time Frame Up to Week 54  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population consisted of all randomized participants who took at least one dose of study medication.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Percentage of Participants Experiencing An Adverse Event (AE) 
[Units: Percentage of participants]
 57.7   60.1   63.4 


Statistical Analysis 1 for Percentage of Participants Experiencing An Adverse Event (AE)
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percentage [3] -5.7
95% Confidence Interval -16.5 to 5.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Experiencing An Adverse Event (AE)
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percentage [3] -3.3
95% Confidence Interval -14.1 to 7.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



3.  Primary:   Percentage of Participants Discontinuing Study Treatment Due to an AE   [ Time Frame: Up to Week 52 ]

Measure Type Primary
Measure Title Percentage of Participants Discontinuing Study Treatment Due to an AE
Measure 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.
Time Frame Up to Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population consisted of all randomized participants who took at least one dose of study medication.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Percentage of Participants Discontinuing Study Treatment Due to an AE 
[Units: Percentage of participants]
 4.5   3.9   3.9 


Statistical Analysis 1 for Percentage of Participants Discontinuing Study Treatment Due to an AE
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percentage [3] 0.6
95% Confidence Interval -4.4 to 5.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Discontinuing Study Treatment Due to an AE
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percentage [3] 0.0
95% Confidence Interval -4.9 to 4.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Secondary
Measure Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Measure 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.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 
[Units: mg/dL]
Least Squares Mean (95% Confidence Interval)
 -26.91 
 (-32.58 to -21.24) 
 -33.04 
 (-38.71 to -27.36) 
 -1.76 
 (-7.70 to 4.18) 


Statistical Analysis 1 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] <0.001
Differenc in least squares means [5] -25.15
95% Confidence Interval -32.76 to -17.54
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] <0.001
Difference in least squares means [5] -31.28
95% Confidence Interval -38.90 to -23.66
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Secondary:   Change From Baseline in Body Weight at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Secondary
Measure Title Change From Baseline in Body Weight at Week 26
Measure 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.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Body Weight at Week 26 
[Units: Kg]
Least Squares Mean (95% Confidence Interval)
 -3.35 
 (-3.78 to -2.91) 
 -3.04 
 (-3.48 to -2.60) 
 -1.32 
 (-1.77 to -0.87) 


Statistical Analysis 1 for Change From Baseline in Body Weight at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] <0.001
Difference in least squares means [5] -2.03
95% Confidence Interval -2.65 to -1.40
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Body Weight at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] <0.001
Difference in least squares means [5] -1.72
95% Confidence Interval -2.35 to -1.09
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



6.  Secondary:   Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26   [ Time Frame: Week 26 ]

Measure Type Secondary
Measure Title Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26
Measure 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.
Time Frame Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26 
[Units: Percentage of participants]
 32.1   39.9   17.0 


Statistical Analysis 1 for Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Logistic
P Value [4] <0.001
Odds Ratio (OR) [5] 3.16
95% Confidence Interval 1.74 to 5.72
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Logistic
P Value [4] <0.001
Difference in least squares means [5] 4.43
95% Confidence Interval 2.44 to 8.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



7.  Secondary:   Change From Baseline in Sitting Systolic Blood Pressure at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Secondary
Measure Title Change From Baseline in Sitting Systolic Blood Pressure at Week 26
Measure 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.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 
[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 1 for Change From Baseline in Sitting Systolic Blood Pressure at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] 0.019
Difference in least squares means [5] -2.93
95% Confidence Interval -5.36 to -0.49
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Sitting Systolic Blood Pressure at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Statistical Method [3] cLDA
P Value [4] 0.002
Difference in least squares means [5] -3.94
95% Confidence Interval -6.39 to -1.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



8.  Secondary:   Change From Baseline in Hemoglobin A1C at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in Hemoglobin A1C at Week 52
Measure 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.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Hemoglobin A1C at Week 52 
[Units: Percent]
Least Squares Mean (95% Confidence Interval)
 -0.75 
 (-0.90 to -0.59) 
 -0.81 
 (-0.97 to -0.66) 
 0.02 
 (-0.15 to 0.19) 


Statistical Analysis 1 for Change From Baseline in Hemoglobin A1C at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -0.76
95% Confidence Interval -0.98 to -0.54
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Hemoglobin A1C at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -0.83
95% Confidence Interval -1.05 to -0.61
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



9.  Secondary:   Change From Baseline in FPG at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in FPG at Week 52
Measure 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.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in FPG at Week 52 
[Units: mg/dL]
Least Squares Mean (95% Confidence Interval)
 -25.57 
 (-30.91 to -20.23) 
 -26.38 
 (-31.80 to -20.97) 
 3.19 
 (-3.08 to 9.47) 


Statistical Analysis 1 for Change From Baseline in FPG at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -28.76
95% Confidence Interval -36.44 to -21.09
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in FPG at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -29.58
95% Confidence Interval -37.30 to -21.85
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



10.  Secondary:   Change From Baseline in Body Weight at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in Body Weight at Week 52
Measure 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.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Body Weight at Week 52 
[Units: Kg]
Least Squares Mean (95% Confidence Interval)
 -3.46 
 (-4.07 to -2.85) 
 -2.83 
 (-3.45 to -2.21) 
 -0.95 
 (-1.65 to -0.26) 


Statistical Analysis 1 for Change From Baseline in Body Weight at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -2.51
95% Confidence Interval -3.43 to -1.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Body Weight at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -1.88
95% Confidence Interval -2.81 to -0.95
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



11.  Secondary:   Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52   [ Time Frame: Week 52 ]

Measure Type Secondary
Measure Title Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52
Measure 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.
Time Frame Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52 
[Units: Percentage of participants]
 33.3   32.7   13.7 


Statistical Analysis 1 for Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Odds Ratio (OR) [3] 3.63
95% Confidence Interval 1.98 to 6.64
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Odds Ratio (OR) [3] 4.02
95% Confidence Interval 2.22 to 7.28
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



12.  Secondary:   Change From Baseline in Sitting Systolic Blood Pressure at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in Sitting Systolic Blood Pressure at Week 52
Measure 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.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Sitting Systolic Blood Pressure at Week 52 
[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 1 for Change From Baseline in Sitting Systolic Blood Pressure at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -4.99
95% Confidence Interval -7.82 to -2.15
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Sitting Systolic Blood Pressure at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -4.92
95% Confidence Interval -7.76 to -2.07
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



13.  Secondary:   Change From Baseline in Sitting Diastolic Blood Pressure at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Secondary
Measure Title Change From Baseline in Sitting Diastolic Blood Pressure at Week 26
Measure 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.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 
[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 1 for Change From Baseline in Sitting Diastolic Blood Pressure at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -1.24
95% Confidence Interval -2.97 to 0.48
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Sitting Diastolic Blood Pressure at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -1.38
95% Confidence Interval -3.11 to 0.36
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



14.  Secondary:   Change From Baseline in Sitting Diastolic Blood Pressure at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in Sitting Diastolic Blood Pressure at Week 52
Measure 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.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 
[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 1 for Change From Baseline in Sitting Diastolic Blood Pressure at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -0.99
95% Confidence Interval -2.82 to 0.84
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Sitting Diastolic Blood Pressure at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -0.85
95% Confidence Interval -2.69 to 0.99
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



15.  Secondary:   Percentage of Participants Receiving Glycemic Rescue Medication by Week 26   [ Time Frame: Week 26 ]

Measure Type Secondary
Measure Title Percentage of Participants Receiving Glycemic Rescue Medication by Week 26
Measure 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).
Time Frame Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all randomized participants who took at least one dose of trial treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Percentage of Participants Receiving Glycemic Rescue Medication by Week 26 
[Units: Percentage of participants]
 1.3   2.0   16.3 


Statistical Analysis 1 for Percentage of Participants Receiving Glycemic Rescue Medication by Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percent [3] -15.1
95% Confidence Interval -21.9 to -9.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Receiving Glycemic Rescue Medication by Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percent [3] -14.4
95% Confidence Interval -21.3 to -8.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



16.  Secondary:   Percentage of Participants Receiving Glycemic Rescue Medication by Week 52   [ Time Frame: Week 52 ]

Measure Type Secondary
Measure Title Percentage of Participants Receiving Glycemic Rescue Medication by Week 52
Measure 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).
Time Frame Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all randomized participants who took at least one dose of trial treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Percentage of Participants Receiving Glycemic Rescue Medication by Week 52 
[Units: Percentage of participants]
 12.8   13.7   41.8 


Statistical Analysis 1 for Percentage of Participants Receiving Glycemic Rescue Medication by Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percentage [3] -29.0
95% Confidence Interval -38.3 to -19.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Receiving Glycemic Rescue Medication by Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in percentage [3] -28.1
95% Confidence Interval -37.5 to -18.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



17.  Secondary:   Time to Initiation of Glycemic Rescue by Week 26   [ Time Frame: Up to Week 26 (plus 30 days for 1 placebo participant) ]

Measure Type Secondary
Measure Title Time to Initiation of Glycemic Rescue by Week 26
Measure 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. Below data include data from 1 participant in the Placebo arm who continued Phase A treatment for an additional 30 days.
Time Frame Up to Week 26 (plus 30 days for 1 placebo participant)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all randomized participants who took at least one dose of trial treatment

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Time to Initiation of Glycemic Rescue by Week 26 
[Units: Days]
     
Minimum time to initiation of glycemic rescue   135   43   26 
Maximum time to initiation of glycemic rescue   141   147   212 

No statistical analysis provided for Time to Initiation of Glycemic Rescue by Week 26



18.  Secondary:   Time to Initiation of Glycemic Rescue by Week 52   [ Time Frame: Up to week 52 ]

Measure Type Secondary
Measure Title Time to Initiation of Glycemic Rescue by Week 52
Measure 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.
Time Frame Up to week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all randomized participants who took at least one dose of trial treatment.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 156   153   153 
Time to Initiation of Glycemic Rescue by Week 52 
[Units: Days]
     
Minimum time to initiation of glycemic rescue   135   43   26 
Maximum time to initiation of glycemic rescue   295   299   327 

No statistical analysis provided for Time to Initiation of Glycemic Rescue by Week 52



19.  Secondary:   Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value   [ Time Frame: Baseline ]

Measure Type Secondary
Measure Title Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value
Measure 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]
Time Frame Baseline  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all randomized participants who took at least one dose of study medication and had HOMA-%β measurement at baseline.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 140   131   127 
Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value 
[Units: Percentage]
Mean (Standard Deviation)
 47.99  (23.890)   48.54  (34.782)   48.04  (30.733) 

No statistical analysis provided for Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value



20.  Secondary:   Change From Baseline in HOMA-%β at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Secondary
Measure Title Change From Baseline in HOMA-%β at Week 26
Measure 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.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 153   151   147 
Change From Baseline in HOMA-%β at Week 26 
[Units: Percentage]
Least Squares Mean (95% Confidence Interval)
 13.28 
 (8.87 to 17.68) 
 12.43 
 (7.94 to 16.93) 
 0.52 
 (-4.08 to 5.12) 


Statistical Analysis 1 for Change From Baseline in HOMA-%β at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] 12.75
95% Confidence Interval 6.83 to 18.68
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in HOMA-%β at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] 11.91
95% Confidence Interval 5.94 to 17.88
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



21.  Secondary:   Change From Baseline in HOMA-%β at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in HOMA-%β at Week 52
Measure 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.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 155   152   152 
Change From Baseline in HOMA-%β at Week 52 
[Units: Percentage]
Least Squares Mean (95% Confidence Interval)
 10.85 
 (6.29 to 15.41) 
 10.93 
 (6.24 to 15.61) 
 -1.93 
 (-6.88 to 3.02) 


Statistical Analysis 1 for Change From Baseline in HOMA-%β at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] 12.78
95% Confidence Interval 6.54 to 19.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in HOMA-%β at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] 12.86
95% Confidence Interval 6.54 to 19.18
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



22.  Secondary:   Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score   [ Time Frame: Baseline ]

Measure Type Secondary
Measure Title Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score
Measure 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 EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best).
Time Frame Baseline  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all randomized participants who took at least one dose of study medication and had a baseline EQ-5D-3L measurement.

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 150   150   152 
Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score 
[Units: Score on a scale]
Mean (Standard Deviation)
 0.88  (0.166)   0.89  (0.182)   0.90  (0.144) 

No statistical analysis provided for Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score



23.  Secondary:   Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26   [ Time Frame: Baseline and Week 26 ]

Measure Type Secondary
Measure Title Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26
Measure 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). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 155   151   153 
Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26 
[Units: Score on a scale]
Least Squares Mean (95% Confidence Interval)
 0.00 
 (-0.02 to 0.03) 
 0.02 
 (-0.00 to 0.04) 
 0.01 
 (-0.01 to 0.04) 


Statistical Analysis 1 for Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -0.01
95% Confidence Interval -0.04 to 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] 0.01
95% Confidence Interval -0.02 to 0.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



24.  Secondary:   Change From Baseline in EQ-5D-3L Score at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Change From Baseline in EQ-5D-3L Score at Week 52
Measure 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). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Ertugliflozin 5 mg Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin 15 mg Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Placebo Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Measured Values
   Ertugliflozin 5 mg   Ertugliflozin 15 mg   Placebo 
Participants Analyzed 
[Units: Participants]
 155   151   153 
Change From Baseline in EQ-5D-3L Score at Week 52 
[Units: Score on a scale]
Least Squares Mean (95% Confidence Interval)
 0.03 
 (-0.00 to 0.05) 
 -0.00 
 (-0.03 to 0.03) 
 0.02 
 (-0.01 to 0.06) 


Statistical Analysis 1 for Change From Baseline in EQ-5D-3L Score at Week 52
Groups [1] Ertugliflozin 5 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] 0.00
95% Confidence Interval -0.04 to 0.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in EQ-5D-3L Score at Week 52
Groups [1] Ertugliflozin 15 mg vs. Placebo
Statistical Test Type [2] Superiority or Other
Difference in least squares means [3] -0.02
95% Confidence Interval -0.07 to 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02036515     History of Changes
Other Study ID Numbers: 8835-006
2013-003697-26 ( EudraCT Number )
B1521015 ( Other Identifier: Pfizer Study Number )
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: May 19, 2017
Results First Posted: July 24, 2017
Last Update Posted: November 10, 2017