Trial Outcomes & Findings for A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019) (NCT NCT01698775)

Last Updated: 2018-08-09

Results Overview

A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

213 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2018-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Omarigliptin (Phase A) → Omarigliptin (Phase B) Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).	Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A STARTED	107	106
Phase A COMPLETED	98	97
Phase A NOT COMPLETED	9	9
Phase B STARTED	98	97
Phase B COMPLETED	84	86
Phase B NOT COMPLETED	14	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Omarigliptin (Phase A) → Omarigliptin (Phase B) Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).	Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Phase A Adverse Event	2	1
Phase A Death	1	1
Phase A Lack of Efficacy	1	0
Phase A Lost to Follow-up	1	2
Phase A Protocol Violation	1	0
Phase A Withdrawal by Subject	3	4
Phase A Kidney [transplant]	0	1
Phase B Hyperglycemia Discontinuation Criteria	0	1
Phase B Adverse Event	6	3
Phase B Death	0	1
Phase B Lack of Efficacy	0	1
Phase B Lost to Follow-up	0	1
Phase B Physician Decision	1	1
Phase B Protocol Violation	1	1
Phase B Withdrawal by Subject	6	2

Baseline Characteristics

A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omarigliptin (Phase A) n=107 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.	Total n=213 Participants Total of all reporting groups
Age, Continuous	65.9 Years STANDARD_DEVIATION 9.4 • n=5 Participants	64.5 Years STANDARD_DEVIATION 9.7 • n=7 Participants	65.2 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	63 Participants n=7 Participants	131 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24	-0.77 Percent Interval -1.0 to -0.54	-0.44 Percent Interval -0.67 to -0.21

PRIMARY outcome

Timeframe: Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)

Population: All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.

An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)	66.0 Percentage of participants	69.8 Percentage of participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: APaT population consists of all randomized participants who took at least 1 dose of trial treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)	2.8 Percentage of participants	0.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 58 weeks (including 28 days following the last dose of study therapy)

Population: APaT population consists of all randomized participants who took at least 1 dose of trial treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)	77.4 Percentage of participants	78.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 54 weeks

Population: APaT population consists of all randomized participants who took at least 1 dose of trial treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)	6.6 Percentage of participants	3.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.

Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-24.6 mg/dL Interval -35.6 to -13.6	-20.7 mg/dL Interval -31.8 to -9.5

SECONDARY outcome

Timeframe: Baseline and Week 54

Population: FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.

A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Change From Baseline in A1C at Week 54	-0.79 Percent Interval -1.1 to -0.47	-0.83 Percent Interval -1.16 to -0.49

SECONDARY outcome

Timeframe: Baseline and Week 54

Population: FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.

Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=106 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Change From Baseline in FPG at Week 54	-19.3 mg/dL Interval -36.5 to -2.1	-16.4 mg/dL Interval -34.4 to 1.6

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).

Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=85 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=83 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24	-0.5 mL/min/1.73 m^2 Interval -2.1 to 1.2	-0.0 mL/min/1.73 m^2 Interval -1.8 to 1.7

SECONDARY outcome

Timeframe: Baseline and Week 54

Population: APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=86 Participants Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=83 Participants Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
Change From Baseline in eGFR at Week 54	-2.0 mL/min/1.73 m^2 Interval -4.0 to -0.1	-2.3 mL/min/1.73 m^2 Interval -4.3 to -0.2

Adverse Events

Omarigliptin (Phase A)

Serious events: 10 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo to Omarigliptin (Phase A)

Serious events: 13 serious events

Other events: 25 other events

Deaths: 0 deaths

Omarigliptin (Phase A) → Omarigliptin (Phase B)

Serious events: 22 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)

Serious events: 22 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Omarigliptin (Phase A) n=106 participants at risk Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=106 participants at risk Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.	Omarigliptin (Phase A) → Omarigliptin (Phase B) n=106 participants at risk Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).	Placebo to Omarigliptin (Phase A) → Glipizide (Phase B) n=106 participants at risk Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
Infections and infestations Upper respiratory tract infection	3.8% 4/106 • Number of events 4 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	7.5% 8/106 • Number of events 9 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	3.8% 4/106 • Number of events 4 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	11.3% 12/106 • Number of events 14 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
Metabolism and nutrition disorders Hypoglycaemia	19.8% 21/106 • Number of events 84 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	17.9% 19/106 • Number of events 88 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	25.5% 27/106 • Number of events 138 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	23.6% 25/106 • Number of events 161 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
General disorders Oedema peripheral	0.00% 0/106 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	1.9% 2/106 • Number of events 2 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	3.8% 4/106 • Number of events 4 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	6.6% 7/106 • Number of events 7 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
Infections and infestations Nasopharyngitis	1.9% 2/106 • Number of events 2 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	3.8% 4/106 • Number of events 5 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	2.8% 3/106 • Number of events 3 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	5.7% 6/106 • Number of events 7 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
Infections and infestations Urinary tract infection	2.8% 3/106 • Number of events 3 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	1.9% 2/106 • Number of events 2 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	6.6% 7/106 • Number of events 8 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	2.8% 3/106 • Number of events 3 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
Investigations Blood creatinine phosphokinase increased	3.8% 4/106 • Number of events 4 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	2.8% 3/106 • Number of events 3 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	5.7% 6/106 • Number of events 6 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	1.9% 2/106 • Number of events 2 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
Investigations Blood glucose increased	0.94% 1/106 • Number of events 1 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	3.8% 4/106 • Number of events 4 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	6.6% 7/106 • Number of events 25 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	5.7% 6/106 • Number of events 6 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 4/106 • Number of events 5 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	1.9% 2/106 • Number of events 2 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	5.7% 6/106 • Number of events 7 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.	2.8% 3/106 • Number of events 3 • Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up) APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER