Omarigliptin vs Glimepiride for Type 2 Diabetes Inadequate Glycemic Control on Metformin

Study start date: September 10, 2012

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