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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02036515
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : July 24, 2017
Last Update Posted : September 13, 2018
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 5 mg
Drug: Ertugliflozin 15 mg
Drug: Placebo for ertugliflozin 5 mg
Drug: Metformin
Drug: Sitagliptin
Drug: Glimepiride
Biological: Insulin
Drug: Placebo for ertugliflozin 10 mg
Enrollment 464
Recruitment Details  
Pre-assignment Details Two participants were randomized to Ertugliflozin 15 mg, but did not receive any treatment.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description Ertugliflozin, 5 mg, oral, once daily for 52 weeks Ertugliflozin, 15 mg, oral, once daily for 52 weeks Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Period Title: Overall Study
Started 156 155 153
Treated 156 153 153
Completed 151 143 139
Not Completed 5 12 14
Reason Not Completed
Adverse Event             1             1             2
Lost to Follow-up             0             2             0
Non-compliance with study drug             0             0             2
Screen failure             0             2             0
Withdrawal by Subject             4             7             9
Hyperglycemia             0             0             1
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo Total
Hide Arm/Group Description Ertugliflozin, 5 mg, oral, once daily for 52 weeks Ertugliflozin, 15 mg, oral, once daily for 52 weeks Matching placebo to ertuglifozin, oral, once daily for 52 weeks Total of all reporting groups
Overall Number of Baseline Participants 156 153 153 462
Hide Baseline Analysis Population Description
All participants as treated population excludes two participants randomized to Ertugliflozin 15 mg but did not receive any treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 153 participants 153 participants 462 participants
59.2  (9.3) 59.7  (8.6) 58.3  (9.2) 59.1  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 153 participants 153 participants 462 participants
Female
75
  48.1%
71
  46.4%
53
  34.6%
199
  43.1%
Male
81
  51.9%
82
  53.6%
100
  65.4%
263
  56.9%
Hemoglobin A1c (A1C)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 156 participants 153 participants 153 participants 462 participants
8.05  (0.86) 8.00  (0.83) 8.03  (0.93) 8.03  (0.88)
[1]
Measure Description: Participants with baseline data: ertugliflozin 5 mg, n=155; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=459
Fasting plasma glucose   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 156 participants 153 participants 153 participants 462 participants
167.7  (37.7) 171.7  (39.1) 169.6  (37.8) 169.7  (38.2)
[1]
Measure Description: Participants with baseline data: ertugliflozin 5 mg, n=156; ertugliflozin 15 mg, n=152; placebo, n=152; total, n=460
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 156 participants 153 participants 153 participants 462 participants
87.6  (18.6) 86.6  (19.5) 86.4  (20.8) 86.9  (19.6)
Estimated glomerular filtration rate (eGFR)  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m^2
Number Analyzed 156 participants 153 participants 153 participants 462 participants
87.0  (17.5) 86.9  (15.6) 89.9  (17.5) 87.9  (16.9)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1C at Week 26
Hide Description A1C is measured as percent. Thus this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.78
(-0.91 to -0.65)
-0.86
(-0.99 to -0.72)
-0.09
(-0.23 to -0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained longitudinal data analysis
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.87 to -0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-0.95 to -0.58
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Experiencing An Adverse Event (AE)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
Time Frame Up to Week 54
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population consisted of all randomized participants who took at least one dose of study medication.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
57.7 60.1 63.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -5.7
Confidence Interval (2-Sided) 95%
-16.5 to 5.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-14.1 to 7.6
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Discontinuing Study Treatment Due to an AE
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population consisted of all randomized participants who took at least one dose of study medication.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
4.5 3.9 3.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-4.4 to 5.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.9 to 4.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Hide Description The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-26.91
(-32.58 to -21.24)
-33.04
(-38.71 to -27.36)
-1.76
(-7.70 to 4.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Differenc in least squares means
Estimated Value -25.15
Confidence Interval (2-Sided) 95%
-32.76 to -17.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -31.28
Confidence Interval (2-Sided) 95%
-38.90 to -23.66
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Body Weight at Week 26
Hide Description The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kg
-3.35
(-3.78 to -2.91)
-3.04
(-3.48 to -2.60)
-1.32
(-1.77 to -0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-2.65 to -1.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.72
Confidence Interval (2-Sided) 95%
-2.35 to -1.09
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26
Hide Description A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
32.1 39.9 17.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.16
Confidence Interval (2-Sided) 95%
1.74 to 5.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 4.43
Confidence Interval (2-Sided) 95%
2.44 to 8.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure at Week 26
Hide Description The change from baseline is the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Baseline 130.87  (0.62) 130.87  (0.62) 130.87  (0.62)
Change from baseline -3.81  (0.87) -4.82  (0.88) -0.88  (0.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -2.93
Confidence Interval (2-Sided) 95%
-5.36 to -0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method cLDA
Comments Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -3.94
Confidence Interval (2-Sided) 95%
-6.39 to -1.50
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Hemoglobin A1C at Week 52
Hide Description A1C is measured as percent. Thus this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.75
(-0.90 to -0.59)
-0.81
(-0.97 to -0.66)
0.02
(-0.15 to 0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-0.98 to -0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.05 to -0.61
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in FPG at Week 52
Hide Description The change from baseline is the Week 52 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-25.57
(-30.91 to -20.23)
-26.38
(-31.80 to -20.97)
3.19
(-3.08 to 9.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -28.76
Confidence Interval (2-Sided) 95%
-36.44 to -21.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -29.58
Confidence Interval (2-Sided) 95%
-37.30 to -21.85
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Body Weight at Week 52
Hide Description The change from baseline is the Week 52 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kg
-3.46
(-4.07 to -2.85)
-2.83
(-3.45 to -2.21)
-0.95
(-1.65 to -0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -2.51
Confidence Interval (2-Sided) 95%
-3.43 to -1.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.88
Confidence Interval (2-Sided) 95%
-2.81 to -0.95
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52
Hide Description A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
33.3 32.7 13.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.63
Confidence Interval (2-Sided) 95%
1.98 to 6.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.02
Confidence Interval (2-Sided) 95%
2.22 to 7.28
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure at Week 52
Hide Description The change from baseline is the Week 52 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Baseline 130.92  (0.62) 130.92  (0.62) 130.92  (0.62)
Change from baseline -4.16  (0.95) -4.09  (0.96) 0.83  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -4.99
Confidence Interval (2-Sided) 95%
-7.82 to -2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -4.92
Confidence Interval (2-Sided) 95%
-7.76 to -2.07
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Sitting Diastolic Blood Pressure at Week 26
Hide Description The change from baseline is the Week 26 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Baseline 78.42  (0.36) 78.42  (0.36) 78.42  (0.36)
Change from baseline -1.68  (0.61) -1.81  (0.62) -0.43  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.24
Confidence Interval (2-Sided) 95%
-2.97 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-3.11 to 0.36
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Sitting Diastolic Blood Pressure at Week 52
Hide Description The change from baseline is the Week 52 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Baseline 78.44  (0.36) 78.44  (0.36) 78.44  (0.36)
Change from baseline -1.52  (0.61) -1.38  (0.62) -0.53  (0.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-2.82 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-2.69 to 0.99
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Receiving Glycemic Rescue Medication by Week 26
Hide Description Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).
Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of trial treatment.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
1.3 2.0 16.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent
Estimated Value -15.1
Confidence Interval (2-Sided) 95%
-21.9 to -9.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-21.3 to -8.5
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Receiving Glycemic Rescue Medication by Week 52
Hide Description Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of trial treatment.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
12.8 13.7 41.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -29.0
Confidence Interval (2-Sided) 95%
-38.3 to -19.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -28.1
Confidence Interval (2-Sided) 95%
-37.5 to -18.4
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Time to Initiation of Glycemic Rescue by Week 26
Hide Description Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days. Below data include data from 1 participant in the Placebo arm who continued Phase A treatment for an additional 30 days.
Time Frame Up to Week 26 (plus 30 days for 1 placebo participant)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of trial treatment
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Days
Minimum time to initiation of glycemic rescue 135 43 26
Maximum time to initiation of glycemic rescue 141 147 212
18.Secondary Outcome
Title Time to Initiation of Glycemic Rescue by Week 52
Hide Description Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days.
Time Frame Up to week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of trial treatment.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 156 153 153
Measure Type: Number
Unit of Measure: Days
Minimum time to initiation of glycemic rescue 135 43 26
Maximum time to initiation of glycemic rescue 295 299 327
19.Secondary Outcome
Title Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value
Hide Description HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had HOMA-%β measurement at baseline.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 140 131 127
Mean (Standard Deviation)
Unit of Measure: Percentage
47.99  (23.890) 48.54  (34.782) 48.04  (30.733)
20.Secondary Outcome
Title Change From Baseline in HOMA-%β at Week 26
Hide Description HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 153 151 147
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage
13.28
(8.87 to 17.68)
12.43
(7.94 to 16.93)
0.52
(-4.08 to 5.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 12.75
Confidence Interval (2-Sided) 95%
6.83 to 18.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 11.91
Confidence Interval (2-Sided) 95%
5.94 to 17.88
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in HOMA-%β at Week 52
Hide Description HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 155 152 152
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage
10.85
(6.29 to 15.41)
10.93
(6.24 to 15.61)
-1.93
(-6.88 to 3.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 12.78
Confidence Interval (2-Sided) 95%
6.54 to 19.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 12.86
Confidence Interval (2-Sided) 95%
6.54 to 19.18
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score
Hide Description The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ visual analogue score (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best).
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had a baseline EQ-5D-3L measurement.
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 150 150 152
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.88  (0.166) 0.89  (0.182) 0.90  (0.144)
23.Secondary Outcome
Title Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26
Hide Description The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 155 151 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
0.00
(-0.02 to 0.03)
0.02
(-0.00 to 0.04)
0.01
(-0.01 to 0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.04 to 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.02 to 0.04
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in EQ-5D-3L Score at Week 52
Hide Description The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with "3" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).
Arm/Group Title Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Hide Arm/Group Description:
Ertugliflozin, 5 mg, oral, once daily for 52 weeks
Ertugliflozin, 15 mg, oral, once daily for 52 weeks
Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Overall Number of Participants Analyzed 155 151 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
0.03
(-0.00 to 0.05)
-0.00
(-0.03 to 0.03)
0.02
(-0.01 to 0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.04 to 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ertugliflozin 15 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.07 to 0.02
Estimation Comments [Not Specified]
Time Frame Up to 54 weeks
Adverse Event Reporting Description Data presented below includes data following the initiation of rescue therapy for the entire study (ie, all data after randomization, with no upper limit on the follow-up window for participants who discontinued study drug). Two participants randomized to ertugliflozin 15 mg didn’t receive any study medication & aren’t included in the below tables
 
Arm/Group Title Ertugliflozin 5 mg (Phase A+B) Ertugliflozin 15 mg (Phase A+B) Placebo (Phase A+B)
Hide Arm/Group Description Ertugliflozin, 5 mg, oral, once daily for 52 weeks Ertugliflozin, 15 mg, oral, once daily for 52 weeks Matching placebo to ertuglifozin, oral, once daily for 52 weeks
All-Cause Mortality
Ertugliflozin 5 mg (Phase A+B) Ertugliflozin 15 mg (Phase A+B) Placebo (Phase A+B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ertugliflozin 5 mg (Phase A+B) Ertugliflozin 15 mg (Phase A+B) Placebo (Phase A+B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/156 (8.33%)      3/153 (1.96%)      8/153 (5.23%)    
Cardiac disorders       
Acute myocardial infarction  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Angina pectoris  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Angina unstable  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Coronary artery disease  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Endocrine disorders       
Goitre  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain lower  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
General disorders       
Non-cardiac chest pain  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Hepatobiliary disorders       
Cholelithiasis  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Liver disorder  1  0/156 (0.00%)  0 1/153 (0.65%)  1 0/153 (0.00%)  0
Infections and infestations       
Appendicitis  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Bone tuberculosis  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Gastroenteritis  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Lymphangitis  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Meningitis tuberculous  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Osteomyelitis  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Pneumonia  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Pyelonephritis acute  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Subcutaneous abscess  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Injury, poisoning and procedural complications       
Femur fracture  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Spinal compression fracture  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bening ear neoplasm  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Bladder cancer  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Invasive ductal breast carcinoma  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Nervous system disorders       
Cerebral haemorrhage  1  0/156 (0.00%)  0 1/153 (0.65%)  1 0/153 (0.00%)  0
Hemiplegia  1  0/156 (0.00%)  0 1/153 (0.65%)  1 0/153 (0.00%)  0
Renal and urinary disorders       
Urge incontinence  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Urinary retention  1  0/156 (0.00%)  0 1/153 (0.65%)  1 0/153 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/156 (0.00%)  0 0/153 (0.00%)  0 1/153 (0.65%)  1
Vascular disorders       
Hypertension  1  1/156 (0.64%)  1 0/153 (0.00%)  0 0/153 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ertugliflozin 5 mg (Phase A+B) Ertugliflozin 15 mg (Phase A+B) Placebo (Phase A+B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/156 (15.38%)      18/153 (11.76%)      29/153 (18.95%)    
Infections and infestations       
Nasopharyngitis  1  8/156 (5.13%)  8 6/153 (3.92%)  6 5/153 (3.27%)  6
Urinary tract infection  1  2/156 (1.28%)  2 5/153 (3.27%)  5 8/153 (5.23%)  9
Metabolism and nutrition disorders       
Hypoglycaemia  1  7/156 (4.49%)  16 5/153 (3.27%)  11 11/153 (7.19%)  18
Musculoskeletal and connective tissue disorders       
Back pain  1  8/156 (5.13%)  8 3/153 (1.96%)  3 6/153 (3.92%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02036515     History of Changes
Other Study ID Numbers: 8835-006
2013-003697-26 ( EudraCT Number )
B1521015 ( Other Identifier: Pfizer Study Number )
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: May 19, 2017
Results First Posted: July 24, 2017
Last Update Posted: September 13, 2018