Trial Outcomes & Findings for A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO) (NCT NCT01958671)
NCT ID: NCT01958671
Last Updated: 2017-09-29
Results Overview
A1C is measured as percent. The change from baseline is 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2017-09-29
Participant Flow
Participant milestones
| Measure |
Ertugliflozin 5 mg/Ertugliflozin 5 mg
Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Ertugliflozin 15 mg/Ertugliflozin 15 mg
Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Placebo/Metformin
Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
|---|---|---|---|
|
Overall Study
STARTED
|
156
|
152
|
153
|
|
Overall Study
COMPLETED
|
137
|
128
|
121
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
32
|
Reasons for withdrawal
| Measure |
Ertugliflozin 5 mg/Ertugliflozin 5 mg
Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Ertugliflozin 15 mg/Ertugliflozin 15 mg
Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Placebo/Metformin
Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
5
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Excluded medication
|
0
|
0
|
1
|
|
Overall Study
Hyperglycemia
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
11
|
7
|
|
Overall Study
Non-compliance with study drug
|
1
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Study site terminated by sponsor
|
1
|
0
|
1
|
|
Overall Study
Participant moved
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
13
|
Baseline Characteristics
All randomized participants who received at least 1 dose of study treatment and had baseline A1C measurement.
Baseline characteristics by cohort
| Measure |
Ertugliflozin 5 mg/Ertugliflozin 5 mg
n=156 Participants
Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Ertugliflozin 15 mg/Ertugliflozin 15 mg
n=152 Participants
Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Placebo/Metformin
n=153 Participants
Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 11.4 • n=156 Participants
|
56.2 Years
STANDARD_DEVIATION 10.8 • n=152 Participants
|
56.1 Years
STANDARD_DEVIATION 10.9 • n=153 Participants
|
56.4 Years
STANDARD_DEVIATION 11.0 • n=461 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=156 Participants
|
62 Participants
n=152 Participants
|
71 Participants
n=153 Participants
|
200 Participants
n=461 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=156 Participants
|
90 Participants
n=152 Participants
|
82 Participants
n=153 Participants
|
261 Participants
n=461 Participants
|
|
Hemoglobin A1c (A1C)
|
8.16 Percent
STANDARD_DEVIATION 0.88 • n=155 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline A1C measurement.
|
8.35 Percent
STANDARD_DEVIATION 1.12 • n=151 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline A1C measurement.
|
8.11 Percent
STANDARD_DEVIATION 0.92 • n=153 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline A1C measurement.
|
8.21 Percent
STANDARD_DEVIATION 0.98 • n=459 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline A1C measurement.
|
|
Fasting plasma glucose (FPG)
|
180.9 mg/dL
STANDARD_DEVIATION 48.5 • n=151 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline FPG measurement.
|
179.1 mg/dL
STANDARD_DEVIATION 48.2 • n=149 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline FPG measurement.
|
180.2 mg/dL
STANDARD_DEVIATION 45.8 • n=150 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline FPG measurement.
|
180.1 mg/dL
STANDARD_DEVIATION 47.4 • n=450 Participants • All randomized participants who received at least 1 dose of study treatment and had baseline FPG measurement.
|
|
Estimated glomerular filtration rate (eGFR)
|
88.5 mL/min/1.75m^2
STANDARD_DEVIATION 18.4 • n=156 Participants
|
88.3 mL/min/1.75m^2
STANDARD_DEVIATION 18.0 • n=152 Participants
|
86.2 mL/min/1.75m^2
STANDARD_DEVIATION 19.4 • n=153 Participants
|
87.7 mL/min/1.75m^2
STANDARD_DEVIATION 18.6 • n=461 Participants
|
|
Body weight
|
94.0 Kilograms
STANDARD_DEVIATION 25.4 • n=156 Participants
|
90.6 Kilograms
STANDARD_DEVIATION 18.3 • n=152 Participants
|
94.2 Kilograms
STANDARD_DEVIATION 25.2 • n=153 Participants
|
92.9 Kilograms
STANDARD_DEVIATION 23.2 • n=461 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.
A1C is measured as percent. The change from baseline is 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.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=151 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=153 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline In A1C at Week 26
|
-0.79 Percent
Interval -0.95 to -0.63
|
-0.96 Percent
Interval -1.12 to -0.8
|
0.20 Percent
Interval 0.02 to 0.37
|
PRIMARY outcome
Timeframe: Up to 54 weeks (including 2 weeks following last dose)Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.
An AE is defined as any untoward medical occurrence in a patient 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.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=153 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants Experiencing An Adverse Event (AE)
|
64.1 Percentage of participants
|
62.5 Percentage of participants
|
66.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.
An AE is defined as any untoward medical occurrence in a patient 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.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=153 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants Discontinuing Study Treatment Due to an AE
|
4.5 Percentage of participants
|
3.9 Percentage of participants
|
6.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline FPG measurement or at least 1 post-randomization FPG measurement subsequent to at least 1 dose of study treatment.
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 glycemic rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=155 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=153 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in FPG at Week 26
|
-33.96 mg/dL
Interval -39.85 to -28.06
|
-43.44 mg/dL
Interval -49.39 to -37.49
|
0.57 mg/dL
Interval -6.02 to 7.16
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline body weight measurement or at least 1 post-randomization body weight measurement subsequent to at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=153 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 26
|
-3.18 Kilograms
Interval -3.72 to -2.63
|
-3.58 Kilograms
Interval -4.13 to -3.02
|
-1.42 Kilograms
Interval -2.02 to -0.81
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=151 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=153 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26
|
28.2 Percentage of participants
|
35.8 Percentage of participants
|
13.1 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population consisted of all randomized participants who had a baseline 2-hr PPG measurement.
Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=145 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=141 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=150 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level
|
260.32 mg/dL
Standard Deviation 76.110
|
262.91 mg/dL
Standard Deviation 78.189
|
256.21 mg/dL
Standard Deviation 76.917
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline 2-hr PPG measurement or at least 1 post-randomization 2-hr PPG measurement subsequent to at least 1 dose of study treatment.
The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=153 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=148 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=151 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in 2-hr PPG at Week 26
|
-64.15 mg/dL
Interval -74.34 to -53.96
|
-62.45 mg/dL
Interval -72.91 to -51.98
|
4.88 mg/dL
Interval -6.15 to 15.92
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population consisted of all randomized participants who had a baseline SBP measurement.
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=155 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=150 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Baseline Sitting Systolic Blood Pressure (SBP)
|
130.49 mmHg
Standard Deviation 13.511
|
129.67 mmHg
Standard Deviation 14.208
|
129.80 mmHg
Standard Deviation 14.464
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline SBP measurement or at least 1 post-randomization SBP measurement subsequent to at least 1 dose of study treatment.
The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=152 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in SBP at Week 26
|
-5.54 mmHg
Interval -7.32 to -3.76
|
-3.93 mmHg
Interval -5.74 to -2.12
|
-2.22 mmHg
Interval -4.3 to -0.14
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population consisted of all randomized participants who had a baseline DBP measurement.
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=155 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=150 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Baseline Sitting Diastolic Blood Pressure (DBP)
|
78.46 mmHg
Standard Deviation 8.117
|
78.53 mmHg
Standard Deviation 7.714
|
78.13 mmHg
Standard Deviation 7.458
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline DBP measurement or at least 1 post-randomization DBP measurement subsequent to at least 1 dose of study treatment.
The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=156 Participants
Participants received ertugliflozin 5 mg once daily for 26 weeks.
|
Ertugliflozin 15 mg
n=152 Participants
Participants received ertugliflozin 15 mg once daily for 26 weeks.
|
Placebo
n=152 Participants
Participants received placebo to ertugliflozin once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in DBP at Week 26
|
-2.52 mmHg
Interval -3.65 to -1.4
|
-1.10 mmHg
Interval -2.24 to 0.05
|
-0.72 mmHg
Interval -2.05 to 0.6
|
Adverse Events
Ertugliflozin 5 mg/Ertugliflozin 5 mg
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Ertugliflozin 15 mg/Ertugliflozin 15 mg
Serious events: 6 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo/Metformin
Serious events: 8 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ertugliflozin 5 mg/Ertugliflozin 5 mg
n=156 participants at risk
Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Ertugliflozin 15 mg/Ertugliflozin 15 mg
n=152 participants at risk
Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Placebo/Metformin
n=153 participants at risk
Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
|---|---|---|---|
|
Eye disorders
Papilloedema
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Eye disorders
Retinal artery occlusion
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Periorbital abscess
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Pneumonia
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Sepsis
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.64%
1/156 • Number of events 2 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Psychiatric disorders
Bipolar disorder
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/156 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.65%
1/153 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Vascular disorders
Hypertension
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Eye disorders
Blindness transient
|
0.64%
1/156 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/152 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.00%
0/153 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
Other adverse events
| Measure |
Ertugliflozin 5 mg/Ertugliflozin 5 mg
n=156 participants at risk
Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Ertugliflozin 15 mg/Ertugliflozin 15 mg
n=152 participants at risk
Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
Placebo/Metformin
n=153 participants at risk
Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.1%
11/156 • Number of events 11 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
1.3%
2/152 • Number of events 2 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
2.6%
4/153 • Number of events 4 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
8/156 • Number of events 10 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
3.3%
5/152 • Number of events 5 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
15.0%
23/153 • Number of events 26 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Gastrointestinal disorders
Nausea
|
2.6%
4/156 • Number of events 4 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
2.0%
3/152 • Number of events 4 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
7.8%
12/153 • Number of events 14 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Bronchitis
|
3.2%
5/156 • Number of events 5 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
0.66%
1/152 • Number of events 1 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
5.2%
8/153 • Number of events 9 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
8/156 • Number of events 8 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
7.2%
11/152 • Number of events 12 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
3.9%
6/153 • Number of events 7 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
9/156 • Number of events 10 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
6.6%
10/152 • Number of events 11 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
5.9%
9/153 • Number of events 15 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Urinary tract infection
|
8.3%
13/156 • Number of events 15 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
6.6%
10/152 • Number of events 14 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
12.4%
19/153 • Number of events 30 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
7.7%
12/156 • Number of events 17 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
5.3%
8/152 • Number of events 11 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
1.3%
2/153 • Number of events 2 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/156 • Number of events 4 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
3.9%
6/152 • Number of events 14 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
6.5%
10/153 • Number of events 23 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
|
Nervous system disorders
Headache
|
3.8%
6/156 • Number of events 10 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
4.6%
7/152 • Number of events 9 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
5.9%
9/153 • Number of events 9 • Up to 54 weeks (+/- 3 days)
Data presented below include 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).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator will provide manuscripts, abstracts, or the full text of any other intended disclosure (poster presentation, invited speaker or guest lecturer presentation, etc.) to Sponsor at least 30 days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, investigator agrees to delay the disclosure for a period not to exceed an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER