Trial Outcomes & Findings for Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020) (NCT NCT01703221)
NCT ID: NCT01703221
Last Updated: 2019-08-28
Results Overview
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
414 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2019-08-28
Participant Flow
Forty-eight sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. One hundred and seventeen participants were not randomized; the most common reason for participants not being randomized was screen failure.
In Phase A, participants were randomized to receive either omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.
Participant milestones
| Measure |
Omarigliptin (Phase A+B)
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
|
Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)
Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
|
Placebo (Phase A) Switching to Omarigliptin (Phase B)
Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
|
|---|---|---|---|
|
Phase A (Up to 24 Weeks)
STARTED
|
166
|
165
|
83
|
|
Phase A (Up to 24 Weeks)
COMPLETED
|
159
|
161
|
80
|
|
Phase A (Up to 24 Weeks)
NOT COMPLETED
|
7
|
4
|
3
|
|
Phase B - (Week 25 to 52)
STARTED
|
159
|
161
|
80
|
|
Phase B - (Week 25 to 52)
COMPLETED
|
143
|
147
|
75
|
|
Phase B - (Week 25 to 52)
NOT COMPLETED
|
16
|
14
|
5
|
Reasons for withdrawal
| Measure |
Omarigliptin (Phase A+B)
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
|
Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)
Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
|
Placebo (Phase A) Switching to Omarigliptin (Phase B)
Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
|
|---|---|---|---|
|
Phase A (Up to 24 Weeks)
Adverse Event
|
2
|
4
|
0
|
|
Phase A (Up to 24 Weeks)
Lack of Efficacy
|
2
|
0
|
1
|
|
Phase A (Up to 24 Weeks)
Physician Decision
|
1
|
0
|
0
|
|
Phase A (Up to 24 Weeks)
Withdrawal by Subject
|
2
|
0
|
1
|
|
Phase A (Up to 24 Weeks)
Protocol Violation
|
0
|
0
|
1
|
|
Phase B - (Week 25 to 52)
Withdrawal by Subject
|
2
|
1
|
0
|
|
Phase B - (Week 25 to 52)
Adverse Event
|
2
|
3
|
2
|
|
Phase B - (Week 25 to 52)
Lack of Efficacy
|
12
|
10
|
3
|
Baseline Characteristics
Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)
Baseline characteristics by cohort
| Measure |
Omarigliptin (Phase A+B)
n=166 Participants
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
|
Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)
n=165 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
|
Placebo (Phase A) Switching to Omarigliptin (Phase B)
n=83 Participants
Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 9 • n=7 Participants
|
61 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
60 Years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
|
-0.66 Percent HbA1c
Interval -0.76 to -0.57
|
-0.65 Percent HbA1c
Interval -0.74 to -0.55
|
0.13 Percent HbA1c
Interval 0.0 to 0.27
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one 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.
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
|
50.0 Percentage of participants
|
49.4 Percentage of participants
|
65.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.
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. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=161 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=80 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
|
69.9 Percentage of Participants
|
47.2 Percentage of Participants
|
56.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: The ASaT Population consisted of all randomized participants who received at least one 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.
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
|
0.6 Percentage of participants
|
1.2 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.
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. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=161 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=80 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
|
2.4 Percentage of participants
|
1.2 Percentage of participants
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.
Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
|
-42.38 mg/dL
Interval -49.53 to -35.23
|
-45.24 mg/dL
Interval -52.31 to -38.16
|
-5.48 mg/dL
Interval -15.13 to 4.17
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
Outcome measures
| Measure |
Omarigliptin (Phase A)
n=166 Participants
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 Participants
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 Participants
Placebo for 24 weeks (Phase A)
|
|---|---|---|---|
|
Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
|
-18.52 mg/dL
Interval -21.81 to -15.22
|
-20.75 mg/dL
Interval -24.1 to -17.39
|
-6.23 mg/dL
Interval -10.84 to -1.63
|
Adverse Events
Omarigliptin (Phase A)
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Sitagliptin (Phase A)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo (Phase A)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Omarigliptin (Phase A + B)
Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths
Omarigliptin (Phase B)-S
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Omarigliptin (Phase B)-P
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omarigliptin (Phase A)
n=166 participants at risk
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 participants at risk
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 participants at risk
Placebo for 24 weeks (Phase A)
|
Omarigliptin (Phase A + B)
n=166 participants at risk
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
|
Omarigliptin (Phase B)-S
n=161 participants at risk
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
|
Omarigliptin (Phase B)-P
n=80 participants at risk
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.60%
1/166 • Number of events 2 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 2 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Vascular disorders
Aortic aneurysm
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.62%
1/161 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.62%
1/161 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.62%
1/161 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/164 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.60%
1/166 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.61%
1/164 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.61%
1/164 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.61%
1/164 • Number of events 1 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/82 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/166 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/161 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
0.00%
0/80 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
Other adverse events
| Measure |
Omarigliptin (Phase A)
n=166 participants at risk
Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
|
Sitagliptin (Phase A)
n=164 participants at risk
Sitagliptin 50 mg once daily for 24 weeks (Phase A)
|
Placebo (Phase A)
n=82 participants at risk
Placebo for 24 weeks (Phase A)
|
Omarigliptin (Phase A + B)
n=166 participants at risk
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
|
Omarigliptin (Phase B)-S
n=161 participants at risk
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
|
Omarigliptin (Phase B)-P
n=80 participants at risk
Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.7%
21/166 • Number of events 24 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
11.0%
18/164 • Number of events 22 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
30.5%
25/82 • Number of events 27 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
27.1%
45/166 • Number of events 58 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
13.7%
22/161 • Number of events 30 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
21.2%
17/80 • Number of events 21 • Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks)
The ASaT population was all randomized participants who received at least 1 study drug. Note: these AE results represent the accrual of AEs over different treatment intervals: 52 weeks, omarigliptin (Phase A+B): double-blind period (DBP) + open label extension period (OLEP) versus 24 weeks (DBP) or 28 weeks (OLEP) for all other study arms.
|
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 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