This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal
Matching placebo to omarigliptin capsule administered orally once weekly
Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal
Change From Baseline in Hemoglobin A1C (A1C) at 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.
Time frame: Baseline and Week 54
Percentage of Participants Who Experienced at Least One Adverse Event
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.
Time frame: Up to 57 weeks (including 3 weeks following the last dose of study drug)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
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.
Time frame: Up to 54 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.
Time frame: Baseline and Week 54
Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
Percentage of participants achieving glycemic goal (A1C \<7% or \<6.5%) after 54 weeks of treatment.
Time frame: 54 weeks
Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment
Percentage of Participants who had an A1C decrease \>0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment
Time frame: 54 weeks
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia
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.
Time frame: Up to 54 weeks
Change From Baseline in Body Weight at Week 54
Body weight was to be measured (in duplicate) using a calibrated digital scale.
Time frame: Baseline and Week 54
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