A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Type 2 diabetes mellitus
- On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
- Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control
Exclusion Criteria:
- History of type 1 diabetes mellitus or a history of ketoacidosis
- Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
- On a weight loss program and is not in the maintenance phase or has
started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
- Medical history of active liver disease (other than non-alcoholic
hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- Human immunodeficiency virus
- New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months
- History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ
cervical cancer
- Clinically important hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Pregnant or breast-feeding, or is expecting to conceive or donate eggs
during the trial, including 21 days following the last dose of study drug
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Omarigliptin
Glimepiride
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.