This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study 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
751
Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.
Participants will continue on their stable dose (\>=1500 mg/day) of open-label metformin throughout the trial.
Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.
Change From Baseline in Hemoglobin A1C at Week 54
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Time frame: Baseline and Week 54
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Time frame: Up to Week 57
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
Time frame: Up to Week 54
Change From Baseline in Fasting Plasma Glucose at Week 54
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
Time frame: Baseline and Week 54
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) in the FAS Population at Week 54.
Time frame: Week 54
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
Time frame: Up to Week 54
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
Time frame: Baseline and Week 54
Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
The percentage of participants who achieved A1C values \<7.0% (53 mmol/mol) in the FAS Population at Week 54.
Time frame: Week 54
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