Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027) (NCT NCT01863667)

Results Overview

A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

Baseline and Week 54

Results posted on

2018-09-10

Participant Flow

The study had a 1-week Screening Period; an oral antihyperglycemic agent (AHA) "wash-off" period of 8 weeks for participants on oral AHAs; a 2-week single-blind placebo run-in period; and a 54-week double-blind treatment period.

Participant milestones

Participant milestones
Measure	Omarigliptin Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.	Glimepiride Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Overall Study STARTED	33	32
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	33	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Omarigliptin Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.	Glimepiride Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Overall Study Adverse Event	1	0
Overall Study Study terminated by Sponsor	30	30
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omarigliptin n=33 Participants Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.	Glimepiride n=32 Participants Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.	Total n=65 Participants Total of all reporting groups
Age, Continuous	58.0 Years STANDARD_DEVIATION 14.1 • n=5 Participants	56.8 Years STANDARD_DEVIATION 9.9 • n=7 Participants	57.4 Years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 54

Population: Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.

A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 57 weeks (including 3 weeks following the last dose of study drug)

Population: All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.

An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

Outcome measures

Outcome measures
Measure	Omarigliptin n=33 Participants Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.	Glimepiride n=32 Participants Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Percentage of Participants Who Experienced at Least One Adverse Event	9.1 Percentage of participants	15.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 54 weeks

Population: All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.

An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

Outcome measures

Outcome measures
Measure	Omarigliptin n=33 Participants Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.	Glimepiride n=32 Participants Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event	3 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 54

Population: Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.

This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 54 weeks

Population: Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.

Percentage of participants achieving glycemic goal (A1C \<7% or \<6.5%) after 54 weeks of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 54 weeks

Population: Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.

Percentage of Participants who had an A1C decrease \>0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 54 weeks

Population: All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.

An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 54

Population: All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.

Body weight was to be measured (in duplicate) using a calibrated digital scale.

Outcome measures

Outcome data not reported

Adverse Events

Omarigliptin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Glimepiride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omarigliptin n=33 participants at risk Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.	Glimepiride n=32 participants at risk Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Nervous system disorders Epilepsy	3.0% 1/33 • Number of events 1 • Up to 57 weeks (including 3 weeks following last dose of study drug) All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/32 • Up to 57 weeks (including 3 weeks following last dose of study drug) All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.

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: [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.
Publication restrictions are in place

Restriction type: OTHER