Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026) (NCT NCT01841697)

NCT ID: NCT01841697

Last Updated: 2018-09-10

Results Overview

A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 642 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2018-09-10

Participant Flow

Participant milestones

Measure	Omarigliptin 25 mg Once Weekly Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Study STARTED	322	320
Overall Study COMPLETED	302	302
Overall Study NOT COMPLETED	20	18

Reasons for withdrawal

Measure	Omarigliptin 25 mg Once Weekly Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Study Death	0	1
Overall Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	16	16

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)

Baseline characteristics by cohort

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Total n=642 Participants Total of all reporting groups
Age, Continuous	57.0 Years STANDARD_DEVIATION 9.8 • n=5 Participants	57.6 Years STANDARD_DEVIATION 9.8 • n=7 Participants	57.3 Years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	171 Participants n=5 Participants	145 Participants n=7 Participants	316 Participants n=5 Participants
Sex: Female, Male Male	151 Participants n=5 Participants	175 Participants n=7 Participants	326 Participants n=5 Participants
Hemoglobin A1c (A1C)	7.52 Percent STANDARD_DEVIATION 0.77 • n=5 Participants	7.49 Percent STANDARD_DEVIATION 0.74 • n=7 Participants	7.50 Percent STANDARD_DEVIATION 0.76 • n=5 Participants
Fasting plasma glucose (FPG)	160.1 mg/dL STANDARD_DEVIATION 35.7 • n=5 Participants	153.9 mg/dL STANDARD_DEVIATION 32.8 • n=7 Participants	157.0 mg/dL STANDARD_DEVIATION 34.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.

Outcome measures

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Change From Baseline in A1C at Week 24	-0.47 Percent Interval -0.55 to -0.38	-0.43 Percent Interval -0.51 to -0.35

PRIMARY outcome

Timeframe: Up to 27 weeks (including 3-week follow-up)

Population: All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.

Outcome measures

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Percentage of Participants Who Experienced at Least One Adverse Event	36.3 Percentage of participants	40.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.

Outcome measures

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event	0.9 Percentage of participants	2.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.

Outcome measures

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Change From Baseline in FPG at Week 24	-13.7 mg/dL Interval -17.3 to -10.1	-9.5 mg/dL Interval -13.2 to -5.9

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.

Outcome measures

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment	50.9 Percentage of participants Interval 48.8 to 59.9	49.1 Percentage of participants Interval 46.8 to 57.9

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.

Outcome measures

Measure	Omarigliptin 25 mg Once Weekly n=322 Participants Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 Participants Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment	27.0 Percentage of participants Interval 24.0 to 34.1	22.8 Percentage of participants Interval 19.9 to 29.5

Adverse Events

Omarigliptin 25 mg Once Weekly

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Sitagliptin 100 mg Once Daily

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omarigliptin 25 mg Once Weekly n=322 participants at risk Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.	Sitagliptin 100 mg Once Daily n=320 participants at risk Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Cardiac disorders Acute myocardial infarction	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Cardiac disorders Angina pectoris	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Cardiac disorders Atrial fibrillation	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Cardiac disorders Myocardial infarction	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Cardiac disorders Myocardial ischaemia	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Ear and labyrinth disorders Vertigo	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Endocrine disorders Hypothyroidism	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
General disorders Non-cardiac chest pain	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Hepatobiliary disorders Cholecystitis	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Hepatobiliary disorders Cholelithiasis	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Infections and infestations Pyelonephritis acute	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Musculoskeletal and connective tissue disorders Back pain	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.62% 2/322 • Number of events 2 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sebaceous adenoma	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Nervous system disorders Cerebrovascular disorder	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Nervous system disorders Diabetic neuropathy	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Nervous system disorders Ischaemic stroke	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Skin and subcutaneous tissue disorders Dematitis contact	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Skin and subcutaneous tissue disorders Psoriasis	0.31% 1/322 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.00% 0/320 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
Vascular disorders Hypertension	0.00% 0/322 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.	0.31% 1/320 • Number of events 1 • Up to 27 weeks (including 3-week follow-up) All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER