Trial Outcomes & Findings for A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016) (NCT NCT01682759)
NCT ID: NCT01682759
Last Updated: 2018-09-07
Results Overview
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
751 participants
Primary outcome timeframe
Baseline and Week 54
Results posted on
2018-09-07
Participant Flow
In total, 1197 participants at 115 clinical sites were screened and 446 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were participants not meeting the metformin inclusion criteria or meeting exclusionary laboratory values.
Participant milestones
| Measure |
Omarigliptin
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
376
|
375
|
|
Overall Study
Treated
|
375
|
375
|
|
Overall Study
COMPLETED
|
307
|
305
|
|
Overall Study
NOT COMPLETED
|
69
|
70
|
Reasons for withdrawal
| Measure |
Omarigliptin
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
13
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
56
|
55
|
Baseline Characteristics
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
Baseline characteristics by cohort
| Measure |
Omarigliptin
n=376 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
Total
n=751 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
|
Hemoglobin A1C
|
7.49 A1C (%)
STANDARD_DEVIATION 0.75 • n=5 Participants
|
7.43 A1C (%)
STANDARD_DEVIATION 0.72 • n=7 Participants
|
7.46 A1C (%)
STANDARD_DEVIATION 0.73 • n=5 Participants
|
|
Fasting Plamsa Glucose (FPG)
|
155.3 mg/dL
STANDARD_DEVIATION 31.4 • n=5 Participants
|
152.7 mg/dL
STANDARD_DEVIATION 30.0 • n=7 Participants
|
154.0 mg/dL
STANDARD_DEVIATION 30.7 • n=5 Participants
|
|
Body Weight
|
87.5 kg
STANDARD_DEVIATION 18.1 • n=5 Participants
|
88.7 kg
STANDARD_DEVIATION 18.7 • n=7 Participants
|
88.1 kg
STANDARD_DEVIATION 18.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 54Population: The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1C at Week 54
|
-0.30 A1C (%)
Interval -0.39 to -0.21
|
-0.48 A1C (%)
Interval -0.57 to -0.39
|
PRIMARY outcome
Timeframe: Up to Week 57Population: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.
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.
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
|
54.7 Percentage of participants
|
61.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
|
3.7 Percentage of participants
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 54
|
-2.7 mg/dL
Interval -6.7 to 1.3
|
-8.3 mg/dL
Interval -12.4 to -4.3
|
SECONDARY outcome
Timeframe: Week 54Population: The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.
The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) in the FAS Population at Week 54.
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
|
25.1 Percentage of participants
Interval 20.6 to 30.2
|
28.8 Percentage of participants
Interval 24.1 to 34.0
|
SECONDARY outcome
Timeframe: Up to Week 54Population: The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.
Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
|
5.3 Percentage of participants
|
26.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
|
-0.4 kg
Interval -0.8 to 0.0
|
1.5 kg
Interval 1.1 to 1.9
|
SECONDARY outcome
Timeframe: Week 54Population: The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.
The percentage of participants who achieved A1C values \<7.0% (53 mmol/mol) in the FAS Population at Week 54.
Outcome measures
| Measure |
Omarigliptin
n=375 Participants
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 Participants
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
|
47.7 Percentage of participants
Interval 42.3 to 53.1
|
58.0 Percentage of participants
Interval 52.7 to 63.1
|
Adverse Events
Omarigliptin
Serious events: 24 serious events
Other events: 43 other events
Deaths: 0 deaths
Glimepiride
Serious events: 18 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omarigliptin
n=375 participants at risk
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 participants at risk
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Angina pectoris
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Cardiac arrest
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Coronary artery disease
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
General disorders
Impaired healing
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
General disorders
Non-cardiac chest pain
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Carbuncle
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 2 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Cholecystitis infective
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Gastroenteritis
|
0.80%
3/375 • Number of events 3 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Injury, poisoning and procedural complications
Dumping syndrome
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.53%
2/375 • Number of events 2 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Epilepsy
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Ischaemic stroke
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Loss of consciousness
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Sciatica
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/375 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
0.27%
1/375 • Number of events 1 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
Other adverse events
| Measure |
Omarigliptin
n=375 participants at risk
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
|
Glimepiride
n=375 participants at risk
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.4%
24/375 • Number of events 31 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
6.1%
23/375 • Number of events 30 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
21/375 • Number of events 45 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
29.3%
110/375 • Number of events 487 • Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
|
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 study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER