Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024) (NCT NCT01755156)

Last Updated: 2018-09-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

402 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2018-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Omarigliptin (Phase A) → Omarigliptin (Phase B) Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.	Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
Phase A (Weeks 0-24) STARTED	201	201
Phase A (Weeks 0-24) COMPLETED	184	177
Phase A (Weeks 0-24) NOT COMPLETED	17	24
Phase B (Weeks 24-104) STARTED	183	177
Phase B (Weeks 24-104) COMPLETED	144	141
Phase B (Weeks 24-104) NOT COMPLETED	39	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Omarigliptin (Phase A) → Omarigliptin (Phase B) Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.	Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
Phase A (Weeks 0-24) Adverse Event	2	3
Phase A (Weeks 0-24) Lack of Efficacy	1	0
Phase A (Weeks 0-24) Lost to Follow-up	5	3
Phase A (Weeks 0-24) Non-compliance with study drug	1	0
Phase A (Weeks 0-24) Physician Decision	0	1
Phase A (Weeks 0-24) Protocol Violation	1	1
Phase A (Weeks 0-24) Withdrawal by Subject	6	13
Phase A (Weeks 0-24) Creatinine or eGFR Discon. Criteria	0	2
Phase A (Weeks 0-24) Need for Excluded Med. Discon. Criteria	1	1
Phase B (Weeks 24-104) Lost to Follow-up	12	5
Phase B (Weeks 24-104) Withdrawal by Subject	27	31

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks	Total n=402 Participants Total of all reporting groups
Age, Continuous	57.5 Years STANDARD_DEVIATION 8.1 • n=5 Participants	56.8 Years STANDARD_DEVIATION 9.1 • n=7 Participants	57.2 Years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	99 Participants n=7 Participants	199 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	102 Participants n=7 Participants	203 Participants n=5 Participants
Hemoglobin A1C (A1C)	8.06 Percent STANDARD_DEVIATION 0.87 • n=5 Participants	8.02 Percent STANDARD_DEVIATION 0.89 • n=7 Participants	8.04 Percent STANDARD_DEVIATION 0.88 • n=5 Participants
2-hour post-meal glucose (2-hr PMG)	240.2 mg/dL STANDARD_DEVIATION 60.5 • n=5 Participants	236.0 mg/dL STANDARD_DEVIATION 59.9 • n=7 Participants	238.1 mg/dL STANDARD_DEVIATION 60.2 • n=5 Participants
Fasting plasma glucose (FPG)	168.8 mg/dL STANDARD_DEVIATION 37.6 • n=5 Participants	168.6 mg/dL STANDARD_DEVIATION 37.2 • n=7 Participants	168.7 mg/dL STANDARD_DEVIATION 37.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A)	-0.54 Percent Interval -0.69 to -0.4	0.00 Percent Interval -0.14 to 0.15

PRIMARY outcome

Timeframe: Up to 107 weeks

Population: All participants as treated population included all participants who received at least one dose of study medication.

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=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)	65.7 Percentage of participants	65.2 Percentage of participants

PRIMARY outcome

Timeframe: Up to 104 weeks

Population: All participants as treated population included all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)	2.0 Percentage of participants	4.5 Percentage of participants

PRIMARY outcome

Timeframe: Up to 104 weeks

Population: All participants as treated population included all participants who received at least one dose of study medication.

The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)	21.9 Percentage of participants	17.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

Change from baseline in 2-hour PMG 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, time, and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=195 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=199 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)	-26.8 mg/dL Interval -34.8 to -18.7	-12.2 mg/dL Interval -20.7 to -3.8

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

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, time, and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A)	-10.7 mg/dL Interval -16.0 to -5.5	-1.2 mg/dL Interval -6.6 to 4.1

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.

A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in A1C at Week 104 (Phase A+B)	-0.42 Percent Interval -0.59 to -0.25	-0.51 Percent Interval -0.68 to -0.34

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.

Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in FPG at Week 104 (Phase A+B)	-7.8 mg/dL Interval -14.4 to -1.3	-18.2 mg/dL Interval -24.7 to -11.7

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

Percentage of participants attaining A1C glycemic goals of \<7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)	38.0 Percentage of participants Interval 31.3 to 45.1	18.8 Percentage of participants Interval 13.9 to 25.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

Percentage of participants attaining A1C glycemic goals of \<6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)	10.6 Percentage of participants Interval 6.8 to 16.2	6.4 Percentage of participants Interval 3.6 to 11.2

SECONDARY outcome

Timeframe: 104 weeks

Population: Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.

Percentage of participants attaining A1C glycemic goals of \<7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)	32.2 Percentage of participants Interval 25.7 to 39.5	39.0 Percentage of participants Interval 31.7 to 46.8

SECONDARY outcome

Timeframe: 104 weeks

Population: Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.

Percentage of participants attaining A1C glycemic goals of \<6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)	13.7 Percentage of participants Interval 9.4 to 19.6	17.9 Percentage of participants Interval 12.5 to 24.8

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=195 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=198 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)	-46.4 mg*h/dL Interval -58.7 to -34.1	-18.6 mg*h/dL Interval -31.5 to -5.7

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.

Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=200 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=200 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in Fasting Insulin at Week 24 (Phase A)	1.8 micro International Unit (μIU)/mL Interval -0.6 to 4.2	-1.9 micro International Unit (μIU)/mL Interval -4.3 to 0.5

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.

Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=200 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)	1.2 μIU/mL Interval -1.9 to 4.2	1.8 μIU/mL Interval -1.2 to 4.8

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All participants randomized population.

Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)	8.5 Percentage of participants Interval 5.3 to 13.6	9.7 Percentage of participants Interval 6.2 to 15.0

SECONDARY outcome

Timeframe: Up to 104 weeks

Population: All participants randomized population.

Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)	20.2 Percentage of participants Interval 14.9 to 27.1	16.2 Percentage of participants Interval 11.5 to 22.7

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All participants randomized population.

Data presented are a cumulative incidence of participants with glycemic rescue by Week 24.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)	8.0 Percentage of participants Interval 5.3 to 13.6	9.0 Percentage of participants Interval 6.2 to 15.0

SECONDARY outcome

Timeframe: Up to 104 weeks

Population: All participants randomized population.

Data presented are a cumulative incidence of participants with glycemic rescue by Week 104.

Outcome measures

Outcome measures
Measure	Omarigliptin (Phase A) n=201 Participants Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 Participants Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)	17.4 Percentage of participants	13.9 Percentage of participants

Adverse Events

Omarigliptin (Phase A)

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo to Omarigliptin (Phase A)

Serious events: 10 serious events

Other events: 17 other events

Deaths: 0 deaths

Omarigliptin (Phase A) → Omarigliptin (Phase B)

Serious events: 12 serious events

Other events: 53 other events

Deaths: 0 deaths

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

Serious events: 18 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Omarigliptin (Phase A) n=201 participants at risk Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.	Placebo to Omarigliptin (Phase A) n=201 participants at risk Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks.	Omarigliptin (Phase A) → Omarigliptin (Phase B) n=201 participants at risk Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.	Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B) n=201 participants at risk Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
Infections and infestations Nasopharyngitis	2.5% 5/201 • Number of events 5 • Up to 107 weeks (treatment period + 21-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.	0.50% 1/201 • Number of events 1 • Up to 107 weeks (treatment period + 21-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.	5.5% 11/201 • Number of events 12 • Up to 107 weeks (treatment period + 21-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.	3.5% 7/201 • Number of events 7 • Up to 107 weeks (treatment period + 21-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	4.5% 9/201 • Number of events 9 • Up to 107 weeks (treatment period + 21-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.	3.5% 7/201 • Number of events 10 • Up to 107 weeks (treatment period + 21-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.	7.0% 14/201 • Number of events 16 • Up to 107 weeks (treatment period + 21-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.	5.0% 10/201 • Number of events 14 • Up to 107 weeks (treatment period + 21-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	3.5% 7/201 • Number of events 13 • Up to 107 weeks (treatment period + 21-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.	2.5% 5/201 • Number of events 8 • Up to 107 weeks (treatment period + 21-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.	8.5% 17/201 • Number of events 43 • Up to 107 weeks (treatment period + 21-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.	15.9% 32/201 • Number of events 112 • Up to 107 weeks (treatment period + 21-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.
Musculoskeletal and connective tissue disorders Arthralgia	1.00% 2/201 • Number of events 3 • Up to 107 weeks (treatment period + 21-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.	0.00% 0/201 • Up to 107 weeks (treatment period + 21-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.	5.5% 11/201 • Number of events 12 • Up to 107 weeks (treatment period + 21-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.	4.0% 8/201 • Number of events 9 • Up to 107 weeks (treatment period + 21-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.
Nervous system disorders Headache	2.5% 5/201 • Number of events 5 • Up to 107 weeks (treatment period + 21-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.	2.5% 5/201 • Number of events 5 • Up to 107 weeks (treatment period + 21-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.	4.0% 8/201 • Number of events 8 • Up to 107 weeks (treatment period + 21-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.	5.5% 11/201 • Number of events 11 • Up to 107 weeks (treatment period + 21-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 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