Trial Outcomes & Findings for Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039) (NCT NCT02906709)
NCT ID: NCT02906709
Last Updated: 2019-09-19
Results Overview
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 16 to determine the Constrained Longitudinal Data Analysis least squares mean HbA1c change from baseline (i.e., HbA1c at Week 16 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in HbA1c levels.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
184 participants
Primary outcome timeframe
Baseline (Day 1) and Week 16
Results posted on
2019-09-19
Participant Flow
Participant milestones
| Measure |
Omarigliptin 25 mg
Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
|
Placebo→Omarigliptin 25 mg
Placebo once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)
|
|---|---|---|
|
Phase A (Week 0 to Week 16)
STARTED
|
123
|
61
|
|
Phase A (Week 0 to Week 16)
COMPLETED
|
122
|
58
|
|
Phase A (Week 0 to Week 16)
NOT COMPLETED
|
1
|
3
|
|
Phase B (Extension, Week 17 to Week 52)
STARTED
|
122
|
58
|
|
Phase B (Extension, Week 17 to Week 52)
COMPLETED
|
117
|
58
|
|
Phase B (Extension, Week 17 to Week 52)
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Omarigliptin 25 mg
Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
|
Placebo→Omarigliptin 25 mg
Placebo once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)
|
|---|---|---|
|
Phase A (Week 0 to Week 16)
Adverse Event
|
1
|
2
|
|
Phase A (Week 0 to Week 16)
Death
|
0
|
1
|
|
Phase B (Extension, Week 17 to Week 52)
Adverse Event
|
3
|
0
|
|
Phase B (Extension, Week 17 to Week 52)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039)
Baseline characteristics by cohort
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
|
Placebo→Omarigliptin 25 mg
n=61 Participants
Placebo once weekly for 16 weeks (Phase A) switching to Omarigliptin 25 mg once weekly for 36 weeks (Phase B)
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
61.0 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
123 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Hemoglobin A1C
|
8.81 Percent A1C
STANDARD_DEVIATION 0.68 • n=5 Participants
|
8.83 Percent A1C
STANDARD_DEVIATION 0.78 • n=7 Participants
|
8.82 Percent A1C
STANDARD_DEVIATION 0.71 • n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
159.1 mg/dL
STANDARD_DEVIATION 31.9 • n=5 Participants
|
152.2 mg/dL
STANDARD_DEVIATION 26.0 • n=7 Participants
|
156.8 mg/dL
STANDARD_DEVIATION 30.2 • n=5 Participants
|
|
Baseline 1,5-anhydroglucitol (1,5-AG) Levels
|
3.6 mg/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
3.4 mg/L
STANDARD_DEVIATION 2.1 • n=7 Participants
|
3.5 mg/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Prior Antihyperglycemic Therapy Status
Yes
|
43 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Prior Antihyperglycemic Therapy Status
No
|
80 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 16 to determine the Constrained Longitudinal Data Analysis least squares mean HbA1c change from baseline (i.e., HbA1c at Week 16 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in HbA1c levels.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A)
|
-0.61 Percent HbA1c
Interval -0.75 to -0.47
|
0.29 Percent HbA1c
Interval 0.09 to 0.49
|
PRIMARY outcome
Timeframe: Up to Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Who Experienced One or More Adverse Events (AE) Excluding Data After Glycemic Rescue (Phase A)
|
51.2 Percentage of participants
|
44.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. The results for the Placebo→Omarigliptin group summarized data from the open label period only (36 weeks), which corresponds to the study interval in which those participants were exposed to omarigliptin.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=58 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Who Experienced One or More AE (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])
|
84.6 Percentage of Participants
|
67.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE Excluding Data After Glycemic Rescue (Phase A)
|
0.8 Percentage of Participants
|
4.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. The results for the Placebo→Omarigliptin group summarized data from the open label period only (36 weeks), which corresponds to the study interval in which those participants were exposed to omarigliptin.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=58 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE Including Data After Glycemic Rescue (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])
|
3.3 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the 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 16 weeks of treatment to determine Constrained Longitudinal Data Analysis change in plasma glucose levels (i.e., FPG at Week 16 minus FPG at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in FPG levels.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Constrained Longitudinal Data Analysis of Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)
|
-11.6 mg/dL
Interval -17.5 to -5.7
|
3.4 mg/dL
Interval -4.7 to 11.5
|
SECONDARY outcome
Timeframe: Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Each of the 10 imputed data sets was summarized to obtain the percentage of responders within each group and were combined using standard multiple imputation techniques to yield an overall estimate of response rate and associated variance for each group. A constrained longitudinal data analysis was used to analyze the data and Wilson score method by treatment groups used for the analysis of percentages of individuals at the HbA1c goals of \<7.0% at Week 16 and the 95% confidence intervals (CIs). Miettinen \& Nurminen (M\&N) method after imputations were used to calculate the treatment differences of the percentages of individuals and the 95% CIs.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)
|
5.8 Percentage of Participants
Interval 2.8 to 11.5
|
0.0 Percentage of Participants
Interval 0.0 to 6.2
|
SECONDARY outcome
Timeframe: Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Each of the 10 imputed data sets was summarized to obtain the percentage of responders within each group and were combined using standard multiple imputation techniques to yield an overall estimate of response rate and associated variance for each group. A constrained longitudinal data analysis was used to analyze the data and Wilson score method by treatment groups used for the analysis of percentages of individuals at the HbA1c goals of \<6.5% at Week 16 and the 95% confidence intervals (CIs). Miettinen \& Nurminen (M\&N) method after imputations were used to calculate the treatment differences of the percentages of individuals and the 95% CIs.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c Goals (<6.5%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)
|
1.7 Percentage of Participants
Interval 0.4 to 5.9
|
0.0 Percentage of Participants
Interval 0.0 to 6.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Data (1,5-AG at Week 16 minus 1,5-AG at baseline) was analyzed by Constrained Longitudinal Data Analysis. Positive data values indicate an increase in 1,5-AG levels and correlate with an improvement in glycemia.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=61 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Constrained Longitudinal Data Analysis of Change From Baseline in 1,5-anhydroglucitol (1,5-AG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)
|
2.9 mg/L
Interval 2.4 to 3.4
|
-0.2 mg/L
Interval -0.9 to 0.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure. Three participants in the Placebo group did not have data to contribute to the analysis.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 52 to determine the mean HbA1c change from baseline (i.e., HbA1c at Week 52 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Negative data values indicated a reduction in HbA1c levels.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=58 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 (Phase A+B)
|
-0.57 Percent A1C
Interval -0.73 to -0.42
|
-0.57 Percent A1C
Interval -0.81 to -0.32
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure. Three participants in the Placebo group did not have data to contribute to the analysis.
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Negative data values indicated a reduction in FPG levels.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=58 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Phase A+B)
|
-11.5 mg/dL
Interval -18.6 to -4.5
|
-5.3 mg/dL
Interval -14.1 to 3.6
|
SECONDARY outcome
Timeframe: Week 52Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization). Three participants in the Placebo group did not have data to contribute to the analysis.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. For the HbA1c goals of \<7.0% at Week 52, the percentage of participants and the 95% confidence intervals were calculated using Wilson score method by treatment groups of the double-blind period.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=58 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 52 (Phase A+B)
|
7.3 Percentage of Participants
Interval 3.9 to 13.3
|
8.6 Percentage of Participants
Interval 3.7 to 18.6
|
SECONDARY outcome
Timeframe: Week 52Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization). Three participants in the Placebo group did not have data to contribute to the analysis.
HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. For the HbA1c goals of \<6.5% at Week 52, the percentage of participants and the 95% confidence intervals were calculated using Wilson score method by treatment groups of the double-blind period.
Outcome measures
| Measure |
Omarigliptin 25 mg
n=123 Participants
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo
n=58 Participants
Placebo once weekly for 16 weeks (Phase A)
|
|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c Goals (<6.5%) at Week 52 (Phase A+B)
|
1.6 Percentage of Participants
Interval 0.4 to 5.7
|
0.0 Percentage of Participants
Since no participants achieved a HbA1c goal of \<6.5% at Week 52, no confidence intervals could be calculated.
|
Adverse Events
Omarigliptin 25 mg (Phase A)
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo (Phase A)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 1 deaths
Omarigliptin 25 mg (Phase A + B)
Serious events: 12 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo→Omarigliptin (Phase B Only)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omarigliptin 25 mg (Phase A)
n=123 participants at risk
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo (Phase A)
n=61 participants at risk
Placebo once weekly for 16 weeks (Phase A)
|
Omarigliptin 25 mg (Phase A + B)
n=123 participants at risk
Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
|
Placebo→Omarigliptin (Phase B Only)
n=58 participants at risk
Omarigliptin 25 mg once weekly for 36 weeks (Phase B) after switching from placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.6%
2/123 • Number of events 2 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Cardiac disorders
Myocardial infarction
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.6%
1/61 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.6%
1/61 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.7%
1/58 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
General disorders
Chest discomfort
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.81%
1/123 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
Other adverse events
| Measure |
Omarigliptin 25 mg (Phase A)
n=123 participants at risk
Omarigliptin 25 mg once weekly for 16 weeks (Phase A)
|
Placebo (Phase A)
n=61 participants at risk
Placebo once weekly for 16 weeks (Phase A)
|
Omarigliptin 25 mg (Phase A + B)
n=123 participants at risk
Omarigliptin 25 mg once weekly for 52 weeks (Phase A and B)
|
Placebo→Omarigliptin (Phase B Only)
n=58 participants at risk
Omarigliptin 25 mg once weekly for 36 weeks (Phase B) after switching from placebo
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.8%
12/123 • Number of events 13 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
8.2%
5/61 • Number of events 5 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
32.5%
40/123 • Number of events 60 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
34.5%
20/58 • Number of events 28 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.6%
18/123 • Number of events 28 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
8.2%
5/61 • Number of events 11 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
24.4%
30/123 • Number of events 98 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
13.8%
8/58 • Number of events 17 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
4/123 • Number of events 4 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.6%
1/61 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
6.5%
8/123 • Number of events 10 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/58 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
4/123 • Number of events 4 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
5.7%
7/123 • Number of events 8 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.7%
1/58 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Infections and infestations
Influenza
|
2.4%
3/123 • Number of events 3 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
5.7%
7/123 • Number of events 8 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
3.4%
2/58 • Number of events 2 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Infections and infestations
Pharyngitis
|
1.6%
2/123 • Number of events 2 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
0.00%
0/61 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
6.5%
8/123 • Number of events 10 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
3.4%
2/58 • Number of events 2 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/123 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.6%
1/61 • Number of events 1 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
1.6%
2/123 • Number of events 2 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
5.2%
3/58 • Number of events 3 • Phase A (Up to 16 weeks), Phase B (Up to 36 weeks [Week 17 to 52]), Phase A+B (Up to 52 weeks)
The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified timeframe. Adverse Events include data after glycemic rescue. The results for the Placebo→Omarigliptin (Phase B only) group summarize data from the open-label period only (36 weeks), which corresponds to the study interval in which participants were exposed to omarigliptin.
|
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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER