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Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)

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ClinicalTrials.gov Identifier: NCT01986881
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : February 15, 2021
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Drug: Placebo
Drug: Glycemic Rescue
Enrollment 8246
Recruitment Details This study included participants in 34 countries at 548 study centers (Overall Cardiovascular Study).
Pre-assignment Details  
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Period Title: Overall Study
Started 2752 2747 2747
Treated 2746 2747 2745
Participants Enrolled in the Insulin +/- Metformin Glycemic Sub-Study 348 370 347
Participants Enrolled in the Sulfonylurea Monotherapy Glycemic Sub-Study 55 54 48
Participants Enrolled in the Metformin With Sulfonylurea Glycemic Sub-Study 100 113 117
Completed 2422 2401 2389
Not Completed 330 346 358
Reason Not Completed
Death             228             233             247
Lost to Follow-up             51             44             55
Physician Decision             7             4             6
Study Site Terminated by Sponsor             2             2             3
Withdrawal by Subject             41             60             45
Subject Moved             0             1             0
Other             1             2             2
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) Total
Hide Arm/Group Description Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years Total of all reporting groups
Overall Number of Baseline Participants 2752 2747 2747 8246
Hide Baseline Analysis Population Description
The analysis population is all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2752 participants 2747 participants 2747 participants 8246 participants
64.3  (8.2) 64.4  (8.0) 64.4  (8.0) 64.4  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2752 participants 2747 participants 2747 participants 8246 participants
Female
801
  29.1%
832
  30.3%
844
  30.7%
2477
  30.0%
Male
1951
  70.9%
1915
  69.7%
1903
  69.3%
5769
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2752 participants 2747 participants 2747 participants 8246 participants
Hispanic or Latino
353
  12.8%
347
  12.6%
343
  12.5%
1043
  12.6%
Not Hispanic or Latino
2390
  86.8%
2392
  87.1%
2399
  87.3%
7181
  87.1%
Unknown or Not Reported
9
   0.3%
8
   0.3%
5
   0.2%
22
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2752 participants 2747 participants 2747 participants 8246 participants
American Indian or Alaska Native
13
   0.5%
8
   0.3%
17
   0.6%
38
   0.5%
Asian
187
   6.8%
149
   5.4%
162
   5.9%
498
   6.0%
Native Hawaiian or Other Pacific Islander
4
   0.1%
10
   0.4%
15
   0.5%
29
   0.4%
Black or African American
91
   3.3%
75
   2.7%
69
   2.5%
235
   2.8%
White
2390
  86.8%
2436
  88.7%
2414
  87.9%
7240
  87.8%
More than one race
67
   2.4%
69
   2.5%
70
   2.5%
206
   2.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fasting Plasma Glucose (FPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 2739 participants 2737 participants 2727 participants 8203 participants
176.1  (52.5) 174.8  (51.6) 173.6  (49.4) 174.8  (51.2)
[1]
Measure Analysis Population Description: The analysis population included all participants with an baseline FPG measurement.
Sitting Systolic Blood Pressure (SBP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2740 participants 2741 participants 2740 participants 8221 participants
133.7  (13.7) 133.2  (13.8) 133.1  (13.9) 133.3  (13.8)
[1]
Measure Analysis Population Description: The analysis population included all participants with a baseline SBP measurement.
Sitting Diastolic Blood Pressure (DBP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2740 participants 2741 participants 2740 participants 8221 participants
76.8  (8.5) 76.7  (8.2) 76.4  (8.7) 76.6  (8.5)
[1]
Measure Analysis Population Description: The analysis population included all participants with a baseline DBP measurement.
Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 2750 participants 2746 participants 2747 participants 8243 participants
91.9  (18.4) 91.6  (18.6) 91.9  (18.3) 91.8  (18.4)
[1]
Measure Analysis Population Description: The analysis population included all participants with a baseline weight measurement.
Hemoglobin A1C (A1C)   [1] 
Mean (Standard Deviation)
Unit of measure:  A1C Percentage
Number Analyzed 2737 participants 2737 participants 2732 participants 8206 participants
8.3  (1.0) 8.2  (1.0) 8.2  (0.9) 8.2  (1.0)
[1]
Measure Analysis Population Description: The analysis population included all participants with a baseline A1C measurement.
Estimated Glomerular Filtration Rate (eGFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m^2
Number Analyzed 2751 participants 2747 participants 2747 participants 8245 participants
76.0  (20.8) 76.2  (20.9) 75.7  (20.8) 76.0  (20.9)
[1]
Measure Analysis Population Description: The analysis population included all participants with a baseline eGFR measurement.
1.Primary Outcome
Title Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study)
Hide Description Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose).
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized into the study and who received at least 1 dose of study medication.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2747 2745 5493
Measure Type: Number
Unit of Measure: Events per 100 Person-years
3.64 4.16 4.01 3.90
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.
Statistical Test of Hypothesis P-Value <0.001
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95.6%
0.848 to 1.114
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95.6%
0.887 to 1.211
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95.6%
0.773 to 1.065
Estimation Comments [Not Specified]
2.Primary Outcome
Title Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.
Arm/Group Title Ertugliflozin 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Ins+/-Met Sub-study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Overall Number of Participants Analyzed 348 370 347
Mean (Standard Deviation)
Unit of Measure: A1C Percentage
8.45  (0.944) 8.38  (0.985) 8.39  (0.928)
3.Primary Outcome
Title Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) from Baseline to Week 18.
Arm/Group Title Ertugliflozin 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Ins+/-Met Sub-study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Overall Number of Participants Analyzed 348 370 347
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.77
(-0.86 to -0.67)
-0.84
(-0.93 to -0.74)
-0.19
(-0.29 to -0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study), Placebo (Ins+/-Met Sub-study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and "Time" was a categorical variable.
Method cLDA Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.78 to -0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Insulin +/- Metformin Glycemic Sub-study), Placebo (Ins+/-Met Sub-study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and "Time" was a categorical variable.
Method Constrained longitudinal data analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-0.71 to -0.44
Estimation Comments [Not Specified]
4.Primary Outcome
Title Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.
Arm/Group Title Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Overall Number of Participants Analyzed 54 54 48
Mean (Standard Deviation)
Unit of Measure: A1C Percentage
8.27  (0.999) 8.39  (1.019) 8.21  (1.169)
5.Primary Outcome
Title Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
Arm/Group Title Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Overall Number of Participants Analyzed 55 54 48
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.91
(-1.17 to -0.65)
-0.78
(-1.06 to -0.51)
-0.56
(-0.84 to -0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study), Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.
Method cLDA Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.60 to 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study), Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.
Method cLDA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.72 to 0.02
Estimation Comments [Not Specified]
6.Primary Outcome
Title Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and had an assessment for the analysis endpoint at Baseline.
Arm/Group Title Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study) Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study) Placebo (Metformin With Sulfonylurea Glycemic Sub-study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Overall Number of Participants Analyzed 99 113 116
Mean (Standard Deviation)
Unit of Measure: A1C Percentage
8.39  (0.960) 8.30  (0.963) 8.27  (0.994)
7.Primary Outcome
Title Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline.
Arm/Group Title Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study) Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study) Placebo (Metformin With Sulfonylurea Glycemic Sub-study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks
Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks
Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Overall Number of Participants Analyzed 100 113 117
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.89
(-1.06 to -0.71)
-0.98
(-1.14 to -0.82)
-0.23
(-0.39 to -0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study), Placebo (Metformin With Sulfonylurea Glycemic Sub-study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.
Method cLDA Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-0.98 to -0.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study), Placebo (Metformin With Sulfonylurea Glycemic Sub-study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.
Method cLDA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-0.89 to -0.43
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
2.36 2.33 2.66 2.34
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95.8%
0.750 to 1.034
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95.8%
0.725 to 1.057
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95.8%
0.735 to 1.068
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study)
Hide Description Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to CV death or time to censoring (the earliest of participants' end of study date or date last known to be alive).
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
1.77 1.74 1.90 1.76
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95.8%
0.767 to 1.113
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95.8%
0.739 to 1.139
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.494
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95.8%
0.750 to 1.154
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
0.87 0.98 1.15 0.93
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95.8%
0.630 to 1.036
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method Cox Proportional Hazard Model
Comments

Model included treatment as an explanatory factor and cohort category as a stratification factor.

Renal

Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95.8%
0.638 to 1.137
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95.8%
0.568 to 1.028
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Time to the first occurrence of any of the following adjudicated components 4-point MACE: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina pectoris. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
4.42 4.67 4.92 4.54
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.823 to 1.038
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.831 to 1.086
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.785 to 1.029
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
1.55 2.00 1.70 1.77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.861 to 1.259
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.949 to 1.451
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.416
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.727 to 1.141
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Time to the first occurrence of fatal and no-fatal stroke. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
0.92 1.04 0.93 0.98
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.663
Comments Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.820 to 1.365
Estimation Comments Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.415
Comments A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.845 to 1.505
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.953
Comments A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.736 to 1.334
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Time to the first occurrence of heart failure requiring hospitalization (adjudicated). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
0.75 0.72 1.05 0.73
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.539 to 0.902
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.502 to 0.932
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.524 to 0.964
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)
Hide Description Time to the occurrence of death from any cause. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or date last known to be alive. The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
2.42 2.46 2.62 2.44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.
Statistical Test of Hypothesis P-Value 0.340
Comments Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.797 to 1.081
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.784 to 1.117
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.363
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model included treatment as an explanatory factor and cohort category as a stratification factor.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.771 to 1.100
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)
Hide Description All events (first and recurrent) of the composite of MACE (3-point major adverse cardiovascular events: cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke) were assessed using Andersen-Gill model. The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
4.35 4.91 4.59 4.63
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.898 to 1.131
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.937 to 1.219
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.828 to 1.085
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study)
Hide Description All events (first and recurrent) of the composite of CV death and HHF were assessed using an Andersen-Gill model. Person-years were calculated as the sum of time from randomization to end of follow-up. The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2752 2747 2747 5499
Measure Type: Number
Unit of Measure: Events per 100 Person-years
2.92 2.71 3.42 2.82
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Overall Cardiovascular Study), All Ertugliflozin (Overall Cardiovascular Study)
Comments Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.716 to 0.945
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.673 to 0.935
Estimation Comments Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.725 to 1.001
Estimation Comments Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.
18.Secondary Outcome
Title Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2745 2747 2742
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.70
(-0.73 to -0.67)
-0.72
(-0.75 to -0.69)
-0.22
(-0.25 to -0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA Model
Comments cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.55 to -0.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA model
Comments cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.53 to -0.44
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2747 2745
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.69
(-0.73 to -0.65)
-0.67
(-0.71 to -0.63)
-0.19
(-0.23 to -0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.54 to -0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.55 to -0.45
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 24 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the specified timepoint(s) at or after baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2747 2745
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.48
(-0.52 to -0.43)
-0.46
(-0.50 to -0.41)
-0.08
(-0.14 to -0.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
Method Constrained longitudinal data analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.45 to -0.30
Estimation Comments Ertugliflozin vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
Method cLDA
Comments Ertugliflozin vs. Placebo.
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.46 to -0.32
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 36 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 36.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1590 1574 1501
Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.42
(-0.47 to -0.37)
-0.38
(-0.43 to -0.33)
-0.04
(-0.10 to 0.01)
22.Secondary Outcome
Title Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 48 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for specified timepoint(s) at or after baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2747 2745
Least Squares Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.22
(-0.29 to -0.15)
-0.17
(-0.24 to -0.10)
0.14
(0.07 to 0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
Method cLDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.41 to -0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
Method cLDA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.46 to -0.26
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 60 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 60.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 526 527 477
Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.25
(-0.35 to -0.15)
-0.28
(-0.38 to -0.18)
-0.10
(-0.20 to 0.00)
24.Secondary Outcome
Title Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study)
Hide Description A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 72 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 72
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 13 12 9
Mean (95% Confidence Interval)
Unit of Measure: A1C Percentage
-0.35
(-0.89 to 0.20)
-0.13
(-0.99 to 0.74)
0.24
(-0.74 to 1.23)
25.Secondary Outcome
Title Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2544 2520 2527
Measure Type: Number
Unit of Measure: Percentage of Participants
28.4 28.2 15.5
26.Secondary Outcome
Title Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2363 2347 2311
Measure Type: Number
Unit of Measure: Percentage of Participants
28.3 29.0 17.4
27.Secondary Outcome
Title Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1570 1541 1496
Measure Type: Number
Unit of Measure: Percentage of Participants
23.9 23.8 16.6
28.Secondary Outcome
Title Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1592 1578 1507
Measure Type: Number
Unit of Measure: Percentage of Participants
23.1 22.7 16.9
29.Secondary Outcome
Title Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 876 860 786
Measure Type: Number
Unit of Measure: Percentage of Participants
24.9 22.7 18.2
30.Secondary Outcome
Title Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 526 529 478
Measure Type: Number
Unit of Measure: Percentage of Participants
18.6 20.0 16.5
31.Secondary Outcome
Title Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2544 2520 2727
Measure Type: Number
Unit of Measure: Percentage of Participants
9.0 8.8 4.7
32.Secondary Outcome
Title Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2363 2347 2311
Measure Type: Number
Unit of Measure: Percentage of Participants
9.4 10.9 6.1
33.Secondary Outcome
Title Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1570 1541 1496
Measure Type: Number
Unit of Measure: Percentage of Participants
9.2 8.6 5.8
34.Secondary Outcome
Title Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1592 1578 1507
Measure Type: Number
Unit of Measure: Percentage of Participants
7.9 8.0 5.8
35.Secondary Outcome
Title Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 876 860 786
Measure Type: Number
Unit of Measure: Percentage of Participants
8.1 9.1 7.5
36.Secondary Outcome
Title Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 526 529 478
Measure Type: Number
Unit of Measure: Percentage of Participants
5.3 9.5 6.5
37.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2745 2747 2744
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-32.18
(-33.76 to -30.61)
-34.64
(-36.21 to -33.08)
-17.08
(-18.69 to -15.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method CLDA
Comments cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -17.56
Confidence Interval (2-Sided) 95%
-19.49 to -15.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -15.10
Confidence Interval (2-Sided) 95%
-17.03 to -13.17
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Week 52 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2352 2328 2295
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-28.63
(-30.52 to -26.74)
-28.97
(-30.78 to -27.15)
-8.76
(-10.75 to -6.77)
39.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Month 24 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1562 1536 1487
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-22.09
(-24.39 to -19.80)
-24.31
(-26.76 to -21.86)
-4.39
(-6.99 to -1.78)
40.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Month 36 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1579 1567 1491
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-19.39
(-21.88 to -16.89)
-22.59
(-24.96 to -20.21)
-3.63
(-6.45 to -0.81)
41.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Month 48 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 868 861 777
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-15.28
(-18.66 to -11.90)
-16.16
(-19.50 to -12.83)
3.59
(-0.22 to 7.40)
42.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Month 60 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 520 524 473
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-13.87
(-18.34 to -9.40)
-11.15
(-15.78 to -6.52)
-4.69
(-9.72 to 0.34)
43.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)
Hide Description FPG was analyzed after an overnight fast. This change from baseline reflects the Month 72 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 72
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 13 12 9
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-2.46
(-31.28 to 26.36)
-84.83
(-127.31 to -42.35)
14.56
(-23.11 to 52.22)
44.Secondary Outcome
Title Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)
Hide Description Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Time Frame Up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and received glycemic rescue by Week 18.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 141 102 275
Median (Inter-Quartile Range)
Unit of Measure: Days
59.0
(36 to 99)
51.0
(18 to 91)
74.0
(37 to 97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).
45.Secondary Outcome
Title Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description Participants who were not on insulin therapy at the start of study medication.
Time Frame Up to approximately 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and were not on insulin therapy at the start of study medication.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1442 1499 1400
Median (Full Range)
Unit of Measure: Days
602
(8 to 1850)
650
(16 to 1934)
482
(10 to 1838)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).
46.Secondary Outcome
Title Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description Baseline reflects Week 0 insulin dose.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized and were treated with insulin at Baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1304 1248 1345
Mean (Standard Deviation)
Unit of Measure: Units/Day
63.82  (48.11) 62.15  (44.46) 65.74  (46.34)
47.Secondary Outcome
Title Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1297 1237 1304
Mean (95% Confidence Interval)
Unit of Measure: Units/Day
1.05
(0.29 to 1.82)
0.81
(-0.10 to 1.71)
3.71
(2.72 to 4.70)
48.Secondary Outcome
Title Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Week 52 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1103 1067 1130
Mean (95% Confidence Interval)
Unit of Measure: Units/Day
0.84
(-0.15 to 1.82)
-1.69
(-2.83 to -0.54)
5.57
(4.16 to 6.98)
49.Secondary Outcome
Title Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 24 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1004 966 998
Mean (95% Confidence Interval)
Unit of Measure: Units/Day
0.45
(-0.72 to 1.63)
-1.58
(-2.95 to -0.21)
6.16
(4.47 to 7.85)
50.Secondary Outcome
Title Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 36 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time Frame Baseline and Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 465 464 419
Mean (95% Confidence Interval)
Unit of Measure: Units/Day
1.64
(-0.77 to 4.05)
-1.92
(-4.31 to 0.46)
7.99
(4.65 to 11.34)
51.Secondary Outcome
Title Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 48 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time Frame Baseline and Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 387 384 326
Mean (95% Confidence Interval)
Unit of Measure: Units/Day
2.96
(0.41 to 5.51)
-1.87
(-4.80 to 1.05)
7.28
(3.66 to 10.91)
52.Secondary Outcome
Title Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 60 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time Frame Baseline and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 45 47 38
Mean (95% Confidence Interval)
Unit of Measure: Units/Day
-2.47
(-9.65 to 4.72)
-1.77
(-11.95 to 8.42)
9.42
(1.46 to 17.39)
53.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2746 2745
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-2.51
(-3.00 to -2.02)
-2.75
(-3.24 to -2.26)
0.03
(-0.48 to 0.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -2.78
Confidence Interval (2-Sided) 95%
-3.45 to -2.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -2.53
Confidence Interval (2-Sided) 95%
-3.21 to -1.86
Estimation Comments [Not Specified]
54.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Week 52 sitting SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2747 2745
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-1.84
(-2.35 to -1.32)
-2.41
(-2.92 to -1.89)
0.75
(0.23 to 1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Mean
Estimated Value -3.15
Confidence Interval (2-Sided) 95%
-3.85 to -2.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -2.58
Confidence Interval (2-Sided) 95%
-3.28 to -1.89
Estimation Comments [Not Specified]
55.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 24 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 2746 2747 2745
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-1.80
(-2.42 to -1.19)
-1.82
(-2.44 to -1.19)
0.90
(0.27 to 1.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -2.72
Confidence Interval (2-Sided) 95%
-3.57 to -1.86
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg (Overall Cardiovascular Study), Placebo (Overall Cardiovascular Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -2.70
Confidence Interval (2-Sided) 95%
-3.56 to -1.85
Estimation Comments [Not Specified]
56.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 36 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 36
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Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
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Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Number of Participants Analyzed 1593 1580 1505
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.55  (14.56) -1.21  (15.05) 0.84  (14.63)
57.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)
Hide Description This change from baseline reflects the Month 48 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time Frame Baseline and Month 48
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Hide Analysis Population Description
The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
Arm/Group Title Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
Hide Arm/Group Description:
Ertugliflozin 5 mg, administered orally, once daily, for up to approx