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A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)

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ClinicalTrials.gov Identifier: NCT01703208
Recruitment Status : Terminated (The study was terminated for business reasons and not due to any safety or efficacy concerns related to omarigliptin)
First Posted : October 10, 2012
Results First Posted : December 12, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Omarigliptin
Drug: Placebo
Enrollment 4202

Recruitment Details

A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant.

An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin.

Pre-assignment Details On April 8, 2016, Merck & Co. Inc. announced that it would not submit marketing applications for omarigliptin (MK-3102) in the US and Europe for business reasons only. Because of this decision, the MK-3102-018 study was terminated early on May 13, 2016. Due to delays in study close-out the Last-Participant-Last-Visit occurred on March 22, 2017.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly Matching placebo to omarigliptin capsule or tablet administered once weekly.
Period Title: Overall Study
Started 2100 2102
Treated 2092 2100
Completed 0 0
Not Completed 2100 2102
Reason Not Completed
Death             61             48
Lack of Efficacy             1             2
Lost to Follow-up             68             62
Non-Compliance with Study Drug             1             0
Excluded Medication             1             2
Site Discontinued Study Participation             23             27
Physician Decision             11             13
Progressive disease             2             2
Protocol Violation             1             1
Study Terminated by Sponsor             1710             1716
Withdrawal by Subject             205             209
Adverse Event             14             19
Technical Problems             0             1
Protocol Deviation             2             0
Arm/Group Title Omarigliptin 25 mg Placebo Total
Hide Arm/Group Description Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly Matching placebo to omarigliptin capsule or tablet administered once weekly. Total of all reporting groups
Overall Number of Baseline Participants 2100 2102 4202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2100 participants 2102 participants 4202 participants
63.7  (8.5) 63.6  (8.5) 63.6  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2100 participants 2102 participants 4202 participants
Female
639
  30.4%
615
  29.3%
1254
  29.8%
Male
1461
  69.6%
1487
  70.7%
2948
  70.2%
Hemoglobin A1C %   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 2100 participants 2102 participants 4202 participants
7.99  (0.86) 8.03  (0.89) 8.01  (0.87)
[1]
Measure Description: Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 2100 participants 2102 participants 4202 participants
184.1  (52.2) 179.5  (45.7) 180.4  (47.8)
1.Primary Outcome
Title Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)
Hide Description Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.
Time Frame Up to 156 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2090 2100
Measure Type: Number
Unit of Measure: Participants
66 70
2.Primary Outcome
Title Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)
Hide Description Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded trial medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants
114 114
3.Primary Outcome
Title Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)
Hide Description Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants′ follow-up time to first event.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded trial medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants/100 Person-years
2.96 2.97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.77 to 1.29
Estimation Comments Based on the proportional hazards model that includes treatment as an explanatory factor.
4.Primary Outcome
Title Change From Baseline in Hemoglobin A1C (A1C) at Week 18
Hide Description A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.
Time Frame Baseline and Week 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.58
(-0.62 to -0.55)
-0.16
(-0.19 to -0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.48 to -0.37
Estimation Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)
Hide Description A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.
Time Frame Baseline and Week 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 535 509
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage
-0.50
(-0.57 to -0.42)
-0.11
(-0.19 to -0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Longitudinal data analysis
Comments Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.
Method of Estimation Estimation Parameter Difference in the LS Means vs Placebo
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.50 to -0.27
Estimation Comments [Not Specified]
6.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change
Hide Description 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.
Time Frame Up to Week 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 535 509
Measure Type: Number
Unit of Measure: Percentage of participants
48.8 49.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent vs. Placebo
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-7.2 to 4.9
Estimation Comments Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
7.Primary Outcome
Title Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change
Hide Description 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.
Time Frame Up to Week 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 535 509
Measure Type: Number
Unit of Measure: Percentage of participants
1.1 0.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage vs. Placebo
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.0 to 1.7
Estimation Comments Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
8.Secondary Outcome
Title Number of Participants With an Event of CV-Related Death
Hide Description Participants with adjudicated and confirmed AEs of cardiovascular-related death.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants
37 35
9.Secondary Outcome
Title Number of Participants With an Event Per 100 Person-Years of CV-Related Death
Hide Description Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants′ follow-up time to event.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants/100 person-years
0.94 0.89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.66 to 1.68
Estimation Comments Based on the proportional hazards model that includes treatment as an explanatory factor.
10.Secondary Outcome
Title Number of Participants With an Event of First MI (Fatal and Non-fatal)
Hide Description Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants
52 60
11.Secondary Outcome
Title Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)
Hide Description Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants′ follow-up time to first event.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants/100 person-years
1.34 1.55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.60 to 1.26
Estimation Comments Based on the proportional hazards model that includes treatment as an explanatory factor.
12.Secondary Outcome
Title Number of Participants With an Event of Stroke (Fatal and Non-fatal)
Hide Description Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants
32 34
13.Secondary Outcome
Title Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)
Hide Description Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants′ follow-up time to event.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants/100 person-years
0.82 0.88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.58 to 1.52
Estimation Comments Based on the proportional hazards model that includes treatment as an explanatory factor.
14.Secondary Outcome
Title Number of Participants With an Event of All-Cause Death
Hide Description All-cause death was death from any cause.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded trial medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants
64 50
15.Secondary Outcome
Title Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death
Hide Description All-cause death was death for any cause. Person-years were calculated as the sum of all participants′ follow-up time to event.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants/100 Person-years
1.63 1.28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.88 to 1.85
Estimation Comments Based on the proportional hazards model that includes treatment as an explanatory factor.
16.Secondary Outcome
Title Change From Baseline in A1C at Week 142
Hide Description A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.
Time Frame Baseline and Week 142
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.36
(-0.47 to -0.25)
-0.06
(-0.17 to 0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the Least Squares Means
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.46 to -0.14
Estimation Comments Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.
17.Secondary Outcome
Title Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months
Hide Description A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data for this efficacy endpoint was not collected, analyzed or summarized.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months
Hide Description This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.
Time Frame Baseline and 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data for this efficacy endpoint was not collected, analyzed or summarized.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline
Hide Description Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data for this efficacy endpoint was not collected, analyzed or summarized.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event
Hide Description 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.
Time Frame Up to 234 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Percentage of participants
78.3 76.8
21.Secondary Outcome
Title Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event
Hide Description 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.
Time Frame Up to 212 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Percentage of participants
4.1 3.6
22.Secondary Outcome
Title Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin
Hide Description This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.
Time Frame Baseline and Week 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 535 509
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-6.8
(-12.1 to -1.5)
-3.6
(-9.1 to 1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments [Not Specified]
Method Longitudinal constrained data analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in the least squares means
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-10.8 to 4.5
Estimation Comments Based on a LDA model including terms for treatment, time and the interaction of time by treatment.
23.Secondary Outcome
Title Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin
Hide Description A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.
Time Frame 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 535 509
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
22.0
(18.5 to 26.1)
10.2
(7.5 to 13.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Estimated using standard multiple imputation techniques.
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Between group rate difference
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
6.9 to 16.8
Estimation Comments [Not Specified]
24.Other Pre-specified Outcome
Title Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)
Hide Description Participants with adjudicated and confirmed events of first hospitalization for heart failure.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants
20 33
25.Other Pre-specified Outcome
Title Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)
Hide Description Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants′ follow-up time to event.
Time Frame Up to 179 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of blinded study medication.
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description:
Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
Matching placebo to omarigliptin capsule or tablet administered once weekly.
Overall Number of Participants Analyzed 2092 2100
Measure Type: Number
Unit of Measure: Participants/100 Person-years
0.51 0.85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.35 to 1.05
Estimation Comments Based on the proportional hazards model that includes treatment as an explanatory factor.
Time Frame Up to 234 weeks
Adverse Event Reporting Description Participants with serious adverse events with an incidence > 0% and with >5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.
 
Arm/Group Title Omarigliptin 25 mg Placebo
Hide Arm/Group Description Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly Matching placebo to omarigliptin capsule or tablet administered once weekly.
All-Cause Mortality
Omarigliptin 25 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omarigliptin 25 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   512/2092 (24.47%)      503/2100 (23.95%)    
Blood and lymphatic system disorders     
Agranulocytosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Anaemia  1  6/2092 (0.29%)  6 4/2100 (0.19%)  4
Coagulation factor deficiency  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Disseminated intravascular coagulation  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Haemorrhagic anaemia  1  0/2092 (0.00%)  0 2/2100 (0.10%)  3
Iron deficiency anaemia  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Lymphadenitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pancytopenia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Splenic infarction  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Thrombocytosis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Cardiac disorders     
Acute coronary syndrome  1  3/2092 (0.14%)  3 7/2100 (0.33%)  7
Acute myocardial infarction  1  30/2092 (1.43%)  35 27/2100 (1.29%)  28
Angina pectoris  1  27/2092 (1.29%)  29 31/2100 (1.48%)  36
Angina unstable  1  33/2092 (1.58%)  39 42/2100 (2.00%)  46
Aortic valve stenosis  1  5/2092 (0.24%)  5 1/2100 (0.05%)  1
Arteriosclerosis coronary artery  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Atrial fibrillation  1  14/2092 (0.67%)  14 16/2100 (0.76%)  17
Atrial flutter  1  5/2092 (0.24%)  7 3/2100 (0.14%)  3
Atrial tachycardia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Atrioventricular block  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Atrioventricular block complete  1  3/2092 (0.14%)  3 0/2100 (0.00%)  0
Bradyarrhythmia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Bradycardia  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Cardiac aneurysm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cardiac arrest  1  9/2092 (0.43%)  9 4/2100 (0.19%)  4
Cardiac failure  1  17/2092 (0.81%)  21 12/2100 (0.57%)  12
Cardiac failure acute  1  6/2092 (0.29%)  6 4/2100 (0.19%)  4
Cardiac failure chronic  1  7/2092 (0.33%)  8 3/2100 (0.14%)  3
Cardiac failure congestive  1  14/2092 (0.67%)  16 20/2100 (0.95%)  25
Cardio-respiratory arrest  1  0/2092 (0.00%)  0 3/2100 (0.14%)  3
Cardiogenic shock  1  2/2092 (0.10%)  2 4/2100 (0.19%)  4
Cardiomyopathy  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Cardiopulmonary failure  1  1/2092 (0.05%)  1 4/2100 (0.19%)  5
Conduction disorder  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cor pulmonale  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Coronary artery disease  1  22/2092 (1.05%)  24 23/2100 (1.10%)  24
Coronary artery insufficiency  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Coronary artery occlusion  1  3/2092 (0.14%)  3 4/2100 (0.19%)  4
Coronary artery stenosis  1  9/2092 (0.43%)  9 6/2100 (0.29%)  6
Ischaemic cardiomyopathy  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Left ventricular failure  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Myocardial infarction  1  19/2092 (0.91%)  19 17/2100 (0.81%)  19
Myocardial ischaemia  1  5/2092 (0.24%)  6 3/2100 (0.14%)  3
Myocardial reperfusion injury  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pericardial effusion  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Right ventricular failure  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Silent myocardial infarction  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Sinus node dysfunction  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Supraventricular tachycardia  1  3/2092 (0.14%)  4 1/2100 (0.05%)  1
Ventricular arrhythmia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Ventricular extrasystoles  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Ventricular fibrillation  1  3/2092 (0.14%)  3 0/2100 (0.00%)  0
Ventricular tachyarrhythmia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Ventricular tachycardia  1  2/2092 (0.10%)  2 3/2100 (0.14%)  4
Trifascicular block  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Congenital, familial and genetic disorders     
Congenital claw toe  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Encephalocele  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Ear and labyrinth disorders     
Deafness neurosensory  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Deafness unilateral  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Vertigo  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Vertigo positional  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Vestibular disorder  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Endocrine disorders     
Goitre  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Eye disorders     
Cataract  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Keratitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Retinal detachment  1  0/2092 (0.00%)  0 2/2100 (0.10%)  3
Retinal haemorrhage  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Retinal tear  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Vitreous haemorrhage  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Gastrointestinal disorders     
Abdominal hernia  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Abdominal pain  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Acquired oesophageal web  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Anal spasm  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Chronic gastritis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Colitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Constipation  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Crohn's disease  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diabetic gastroenteropathy  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diabetic gastroparesis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diarrhoea  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Diverticular perforation  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diverticulum  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Duodenal ulcer  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Enterovesical fistula  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Food poisoning  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Gastric polyps  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Gastric ulcer  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Gastric ulcer haemorrhage  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Gastric varices haemorrhage  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Gastritis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Gastritis erosive  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Gastroduodenitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Gastrointestinal disorder  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Gastrointestinal haemorrhage  1  2/2092 (0.10%)  2 2/2100 (0.10%)  2
Gastrointestinal ulcer haemorrhage  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Gastrooesophageal reflux disease  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Ileus  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Ileus paralytic  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Impaired gastric emptying  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Incarcerated umbilical hernia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Inguinal hernia  1  5/2092 (0.24%)  6 2/2100 (0.10%)  2
Intestinal obstruction  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Large intestine polyp  1  1/2092 (0.05%)  1 4/2100 (0.19%)  4
Lower gastrointestinal haemorrhage  1  0/2092 (0.00%)  0 2/2100 (0.10%)  3
Noninfective gingivitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Oesophagitis  1  3/2092 (0.14%)  3 0/2100 (0.00%)  0
Pancreatic cyst  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pancreatitis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Pancreatitis acute  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Pancreatitis chronic  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Peptic ulcer  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Rectal haemorrhage  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Retroperitoneal haematoma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Small intestinal obstruction  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Strangulated umbilical hernia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Vomiting  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
General disorders     
Cardiac death  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Chest pain  1  6/2092 (0.29%)  8 1/2100 (0.05%)  1
Complication associated with device  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Death  1  4/2092 (0.19%)  4 0/2100 (0.00%)  0
Multiple organ dysfunction syndrome  1  5/2092 (0.24%)  5 1/2100 (0.05%)  1
Non-cardiac chest pain  1  5/2092 (0.24%)  5 8/2100 (0.38%)  10
Sudden cardiac death  1  0/2092 (0.00%)  0 4/2100 (0.19%)  4
Sudden death  1  6/2092 (0.29%)  6 3/2100 (0.14%)  3
Vascular stent restenosis  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Catheter site haemorrhage  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Vascular stent thrombosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Cholangitis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Cholecystitis  1  7/2092 (0.33%)  7 3/2100 (0.14%)  3
Cholecystitis acute  1  4/2092 (0.19%)  4 4/2100 (0.19%)  4
Cholecystitis chronic  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cholelithiasis  1  5/2092 (0.24%)  5 3/2100 (0.14%)  3
Hepatic cirrhosis  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Hepatorenal syndrome  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Hydrocholecystis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Jaundice  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Hypersensitivity  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Infections and infestations     
Abdominal abscess  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Abscess intestinal  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Abscess limb  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Appendicitis  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Atypical pneumonia  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Bacterial sepsis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Bronchitis  1  6/2092 (0.29%)  6 2/2100 (0.10%)  2
Bronchitis viral  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Bronchopulmonary aspergillosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Bronchopulmonary aspergillosis allergic  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cellulitis  1  11/2092 (0.53%)  11 2/2100 (0.10%)  3
Chronic hepatitis C  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cystitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diabetic foot infection  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diabetic gangrene  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Diverticulitis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Endocarditis bacterial  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Endophthalmitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Enterococcal sepsis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Epididymitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Erysipelas  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Escherichia urinary tract infection  1  0/2092 (0.00%)  0 3/2100 (0.14%)  3
Febrile infection  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Fungal infection  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Gangrene  1  6/2092 (0.29%)  7 4/2100 (0.19%)  4
Gas gangrene  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Gastroenteritis  1  3/2092 (0.14%)  4 3/2100 (0.14%)  3
Gastroenteritis viral  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
HIV infection  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Infection  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Infectious pleural effusion  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Infective exacerbation of bronchiectasis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Kidney infection  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Klebsiella sepsis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Lower respiratory tract infection  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Lung infection  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Mediastinitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Neuroborreliosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Nosocomial infection  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Osteomyelitis  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Paronychia  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Parotitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Pelvic sepsis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Perirectal abscess  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pneumonia  1  35/2092 (1.67%)  37 31/2100 (1.48%)  31
Pneumonia respiratory syncytial viral  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pneumonia streptococcal  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Pneumonia viral  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Postoperative abscess  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Pulmonary tuberculosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pyelonephritis  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Pyelonephritis acute  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Respiratory tract infection  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Respiratory tract infection viral  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Sepsis  1  7/2092 (0.33%)  7 5/2100 (0.24%)  5
Septic shock  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Sinusitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Subdural empyema  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Tuberculosis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Upper respiratory tract infection  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Urinary tract infection  1  4/2092 (0.19%)  4 6/2100 (0.29%)  6
Urinary tract infection bacterial  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Urosepsis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Viral infection  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Vulval abscess  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Wound infection  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Bacteraemia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Injury, poisoning and procedural complications     
Acetabulum fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Alcohol poisoning  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Ankle fracture  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Avulsion fracture  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Cardiac procedure complication  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cervical vertebral fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Chemical peritonitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Concussion  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Contusion  1  2/2092 (0.10%)  2 2/2100 (0.10%)  3
Coronary artery restenosis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Craniocerebral injury  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Cystitis radiation  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Face injury  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Fall  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Femoral neck fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Femur fracture  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Fibula fracture  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Flail chest  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Foot fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Forearm fracture  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Gastrointestinal anastomotic leak  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Head injury  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Hip fracture  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Humerus fracture  1  2/2092 (0.10%)  2 2/2100 (0.10%)  2
Incarcerated incisional hernia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Incisional hernia  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Jaw fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Joint dislocation  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Limb injury  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Lower limb fracture  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Meniscus injury  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Multiple injuries  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Post procedural complication  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Post procedural haemorrhage  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Postoperative ileus  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Procedural haemorrhage  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Radius fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Rib fracture  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Road traffic accident  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Soft tissue injury  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Spinal cord injury cervical  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Stomal hernia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Subdural haematoma  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Synovial rupture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Thermal burn  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Tibia fracture  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Toxicity to various agents  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Traumatic haemorrhage  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Upper limb fracture  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Vascular graft occlusion  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Vascular pseudoaneurysm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Wrist fracture  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Procedural pneumothorax  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Traumatic intracranial haemorrhage  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Blood glucose increased  1  1/2092 (0.05%)  1 6/2100 (0.29%)  6
Blood sodium decreased  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Heart rate increased  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Troponin increased  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Diabetes mellitus  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Diabetes mellitus inadequate control  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diabetic ketoacidosis  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Diabetic metabolic decompensation  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Fluid overload  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Gout  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Hyperglycaemia  1  5/2092 (0.24%)  5 7/2100 (0.33%)  7
Hyperkalaemia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Hypoglycaemia  1  3/2092 (0.14%)  4 5/2100 (0.24%)  5
Hypokalaemia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  2
Obesity  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Musculoskeletal and connective tissue disorders     
Amyotrophy  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Arthralgia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Back pain  1  2/2092 (0.10%)  2 2/2100 (0.10%)  2
Bursitis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Flank pain  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Foot deformity  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Gouty arthritis  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Intervertebral disc disorder  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Intervertebral disc protrusion  1  2/2092 (0.10%)  2 4/2100 (0.19%)  4
Lumbar spinal stenosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Muscular weakness  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Musculoskeletal chest pain  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Osteitis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Osteoarthritis  1  14/2092 (0.67%)  15 9/2100 (0.43%)  9
Pain in extremity  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Periarthritis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Rotator cuff syndrome  1  4/2092 (0.19%)  4 0/2100 (0.00%)  0
Spinal column stenosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Spinal osteoarthritis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Spinal pain  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Spondylolisthesis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Trigger finger  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Adenocarcinoma of colon  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Basal cell carcinoma  1  5/2092 (0.24%)  6 10/2100 (0.48%)  15
Benign neoplasm of eyelid  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Benign renal neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Bladder cancer  1  2/2092 (0.10%)  2 5/2100 (0.24%)  5
Bladder cancer recurrent  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Bladder neoplasm  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Bladder transitional cell carcinoma  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Bone cancer  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Brain neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Breast cancer  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Breast cancer in situ  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Breast cancer metastatic  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Bronchial carcinoma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cholangiocarcinoma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Colon adenoma  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Colon cancer  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Colorectal cancer  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Gastric cancer  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Gastrooesophageal cancer  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Hepatic cancer  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Hepatic neoplasm  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Hodgkin's disease  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Intraductal proliferative breast lesion  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Lung adenocarcinoma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Lung cancer metastatic  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Lung carcinoma cell type unspecified stage IV  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Lung neoplasm malignant  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Lung squamous cell carcinoma stage II  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Malignant melanoma  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Meningioma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Metastases to liver  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Metastatic gastric cancer  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Neoplasm malignant  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Neuroendocrine carcinoma  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Non-Hodgkin's lymphoma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Oesophageal carcinoma  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Pancreatic carcinoma  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Pancreatic carcinoma metastatic  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Pancreatic neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Parathyroid tumour benign  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Plasma cell myeloma  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Prostate cancer  1  7/2092 (0.33%)  7 4/2100 (0.19%)  4
Prostate cancer stage 0  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Prostate cancer stage II  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Prostatic adenoma  1  0/2092 (0.00%)  0 3/2100 (0.14%)  3
Rectal cancer  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Renal cancer  1  4/2092 (0.19%)  4 2/2100 (0.10%)  2
Renal cell carcinoma  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Small cell lung cancer  1  2/2092 (0.10%)  2 1/2100 (0.05%)  2
Small cell lung cancer metastatic  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Squamous cell carcinoma  1  2/2092 (0.10%)  3 5/2100 (0.24%)  9
Squamous cell carcinoma of skin  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Tonsil cancer metastatic  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Transitional cell carcinoma  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Urinary tract neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Vocal cord neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Benign ear neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Bowen's disease  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Ear neoplasm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Nervous system disorders     
Altered state of consciousness  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Ataxia  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Basal ganglia infarction  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Basal ganglia stroke  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Brain stem infarction  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Carotid artery stenosis  1  4/2092 (0.19%)  4 7/2100 (0.33%)  7
Cauda equina syndrome  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Cerebral haemorrhage  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Cerebral infarction  1  4/2092 (0.19%)  4 2/2100 (0.10%)  2
Cerebral ischaemia  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Cerebral small vessel ischaemic disease  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Cerebrovascular accident  1  9/2092 (0.43%)  10 9/2100 (0.43%)  9
Cerebrovascular insufficiency  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Cervical radiculopathy  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Cervicobrachial syndrome  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Coma  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Dementia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Dementia Alzheimer's type  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Diabetic neuropathy  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Dizziness  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Embolic stroke  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Encephalopathy  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Epilepsy  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Facial paralysis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Haemorrhagic stroke  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Headache  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Hypertensive encephalopathy  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
IIIrd nerve paralysis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Intracranial aneurysm  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Ischaemic stroke  1  11/2092 (0.53%)  11 17/2100 (0.81%)  17
Lacunar infarction  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Loss of consciousness  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Lumbar radiculopathy  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Meralgia paraesthetica  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Migraine  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Monoparesis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Myelitis transverse  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Nerve root compression  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Parkinson's disease  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Presyncope  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Radiculopathy  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Syncope  1  7/2092 (0.33%)  8 2/2100 (0.10%)  4
Thalamic infarction  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Toxic encephalopathy  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Transient ischaemic attack  1  11/2092 (0.53%)  11 11/2100 (0.52%)  11
VIth nerve paralysis  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Vascular dementia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Vertebrobasilar insufficiency  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Cerebellar infarction  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Product Issues     
Device breakage  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Device malfunction  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Psychiatric disorders     
Abnormal behaviour  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Acute stress disorder  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Alcoholism  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Confusional state  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Depression  1  2/2092 (0.10%)  2 3/2100 (0.14%)  3
Major depression  1  0/2092 (0.00%)  0 2/2100 (0.10%)  2
Mental disorder  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Panic attack  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Schizophrenia  1  1/2092 (0.05%)  3 0/2100 (0.00%)  0
Somatic symptom disorder  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Stress  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Substance-induced mood disorder  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Suicide attempt  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Renal and urinary disorders     
Acute kidney injury  1  11/2092 (0.53%)  11 6/2100 (0.29%)  6
Calculus urethral  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Calculus urinary  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Chronic kidney disease  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Dysuria  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Haematuria  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Haemorrhage urinary tract  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Nephrolithiasis  1  5/2092 (0.24%)  5 2/2100 (0.10%)  2
Renal colic  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Renal failure  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Stag horn calculus  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Ureteric stenosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Ureterolithiasis  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Urethral stenosis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Urinary incontinence  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Urinary retention  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Breast fibrosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Genital prolapse  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Ovarian cyst  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Prostatic dysplasia  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Prostatitis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Uterine haemorrhage  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Uterine prolapse  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  2/2092 (0.10%)  2 2/2100 (0.10%)  2
Acute respiratory failure  1  6/2092 (0.29%)  6 1/2100 (0.05%)  1
Asthma  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Chronic obstructive pulmonary disease  1  7/2092 (0.33%)  9 5/2100 (0.24%)  6
Dyspnoea  1  1/2092 (0.05%)  1 5/2100 (0.24%)  5
Dyspnoea exertional  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Epistaxis  1  1/2092 (0.05%)  1 1/2100 (0.05%)  1
Hypoxia  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Pleural effusion  1  3/2092 (0.14%)  3 1/2100 (0.05%)  1
Pleurisy  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pneumonia aspiration  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Pneumothorax  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Pulmonary embolism  1  1/2092 (0.05%)  1 3/2100 (0.14%)  3
Pulmonary mass  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Pulmonary oedema  1  3/2092 (0.14%)  3 3/2100 (0.14%)  3
Respiratory failure  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Sleep apnoea syndrome  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Dermatosis  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Diabetic foot  1  1/2092 (0.05%)  1 3/2100 (0.14%)  4
Eczema  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Skin lesion  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Skin ulcer  1  6/2092 (0.29%)  6 0/2100 (0.00%)  0
Vascular disorders     
Aortic aneurysm  1  2/2092 (0.10%)  2 1/2100 (0.05%)  1
Aortic stenosis  1  1/2092 (0.05%)  1 2/2100 (0.10%)  2
Arterial occlusive disease  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Circulatory collapse  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Deep vein thrombosis  1  2/2092 (0.10%)  2 3/2100 (0.14%)  4
Dry gangrene  1  2/2092 (0.10%)  2 0/2100 (0.00%)  0
Extremity necrosis  1  2/2092 (0.10%)  2 2/2100 (0.10%)  2
Haematoma  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Hypertension  1  7/2092 (0.33%)  7 8/2100 (0.38%)  8
Hypertensive crisis  1  2/2092 (0.10%)  2 3/2100 (0.14%)  3
Hypertensive emergency  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Hypotension  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Iliac artery occlusion  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Intermittent claudication  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Orthostatic hypotension  1  1/2092 (0.05%)  1 0/2100 (0.00%)  0
Peripheral arterial occlusive disease  1  14/2092 (0.67%)  17 10/2100 (0.48%)  11
Peripheral artery occlusion  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Peripheral artery stenosis  1  3/2092 (0.14%)  3 2/2100 (0.10%)  2
Peripheral artery thrombosis  1  0/2092 (0.00%)  0 1/2100 (0.05%)  1
Peripheral ischaemia  1  1/2092 (0.05%)  2 4/2100 (0.19%)  4
Peripheral vascular disorder  1  4/2092 (0.19%)  4 1/2100 (0.05%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omarigliptin 25 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   788/2092 (37.67%)      794/2100 (37.81%)    
Infections and infestations     
Nasopharyngitis  1  123/2092 (5.88%)  167 145/2100 (6.90%)  195
Upper respiratory tract infection  1  123/2092 (5.88%)  163 120/2100 (5.71%)  150
Urinary tract infection  1  108/2092 (5.16%)  131 98/2100 (4.67%)  141
Investigations     
Blood glucose increased  1  97/2092 (4.64%)  139 139/2100 (6.62%)  199
Metabolism and nutrition disorders     
Hypoglycaemia  1  530/2092 (25.33%)  3990 473/2100 (22.52%)  3688
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01703208     History of Changes
Other Study ID Numbers: 3102-018
2012-002414-39 ( EudraCT Number )
MK-3102-018 ( Other Identifier: Merck study number )
First Submitted: October 5, 2012
First Posted: October 10, 2012
Results First Submitted: November 13, 2017
Results First Posted: December 12, 2017
Last Update Posted: November 6, 2018