This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
642
Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks
Sitagliptin 100 mg oral tablet once a day for 24 weeks
Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks
Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
Change From Baseline in A1C at Week 24
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.
Time frame: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event
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.
Time frame: Up to 27 weeks (including 3-week follow-up)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
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.
Time frame: Up to 24 weeks
Change From Baseline in FPG at Week 24
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.
Time frame: Baseline and Week 24
Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment
Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C \<7.0% at Week 24.
Time frame: Week 24
Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment
Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C \<6.5% at Week 24.
Time frame: Week 24
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