Trial Outcomes & Findings for Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017) (NCT NCT02226003)
NCT ID: NCT02226003
Last Updated: 2018-09-13
Results Overview
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
COMPLETED
PHASE3
291 participants
Baseline and Week 26
2018-09-13
Participant Flow
A total of 96 sites received independent ethics committees/institutional review boards' approval and 66 sites in 9 countries enrolled at least 1 participant.
The study included a 1-week screening period; an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period; and a 2-week single-blind placebo run-in period.
Participant milestones
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
96
|
97
|
|
Overall Study
COMPLETED
|
96
|
95
|
91
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
6
|
Reasons for withdrawal
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
Baseline Characteristics
Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
Baseline characteristics by cohort
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.4 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
56.1 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
54.3 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
55.6 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=96 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach
|
-1.60 Percentage
Interval -1.82 to -1.39
|
-1.68 Percentage
Interval -1.9 to -1.46
|
-0.44 Percentage
Interval -0.69 to -0.19
|
PRIMARY outcome
Timeframe: Up to Week 28Population: All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach
|
44.9 Percentage of Participants
|
44.8 Percentage of Participants
|
42.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 26Population: ASaT population consisted of all randomized participants who received at least one dose of a study drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach
|
2.0 Percentage of Participants
|
2.1 Percentage of Participants
|
2.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.
Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=96 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach
|
-48.25 milligrams/deciliter
Interval -56.12 to -40.38
|
-55.36 milligrams/deciliter
Interval -63.29 to -47.42
|
-9.30 milligrams/deciliter
Interval -18.58 to -0.02
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.
Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=97 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=95 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=91 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach
|
-82.80 milligrams/deciliter
Interval -95.96 to -69.64
|
-90.03 milligrams/deciliter
Interval -103.34 to -76.71
|
-20.38 milligrams/deciliter
Interval -35.62 to -5.14
|
SECONDARY outcome
Timeframe: Week 26Population: FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=96 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26
|
35.7 Percentage of participants
|
31.3 Percentage of participants
|
8.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.
Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach
|
-2.94 Kilograms
Interval -3.6 to -2.28
|
-3.04 Kilograms
Interval -3.71 to -2.38
|
-0.94 Kilograms
Interval -1.7 to -0.18
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.
Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach
|
-2.04 millimeters of mercury
Interval -4.23 to 0.16
|
-3.98 millimeters of mercury
Interval -6.19 to -1.78
|
2.41 millimeters of mercury
Interval -0.34 to 5.15
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.
Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Outcome measures
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 Participants
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 Participants
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 Participants
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach
|
-0.44 millimeters of mercury
Interval -1.99 to 1.11
|
-0.97 millimeters of mercury
Interval -2.52 to 0.59
|
1.21 millimeters of mercury
Interval -0.73 to 3.15
|
Adverse Events
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + Sitagliptin 100 mg
Placebo
Serious adverse events
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 participants at risk
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 participants at risk
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 participants at risk
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.0%
1/98 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/97 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/96 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/97 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.0%
1/98 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/97 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/96 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/97 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/96 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/97 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
Other adverse events
| Measure |
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=98 participants at risk
Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=96 participants at risk
Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
|
Placebo
n=97 participants at risk
Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
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|---|---|---|---|
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Infections and infestations
Urinary tract infection
|
5.1%
5/98 • Number of events 6 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
2.1%
2/96 • Number of events 2 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/97 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Investigations
Blood glucose increased
|
3.1%
3/98 • Number of events 4 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
0.00%
0/96 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
7.2%
7/97 • Number of events 14 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/98 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
1.0%
1/96 • Number of events 1 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
6.2%
6/97 • Number of events 6 • Up to Week 28
The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER