Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Brief Summary: 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.


Options:
A: 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
B: Inclusion Criteria:

* Type 2 diabetes
* Inadequate blood sugar control
* No current treatment with other medications to lower blood sugar

Exclusion Criteria:

* Major heart, liver or kidney problems
* Pregnant or breast feeding
C: Inclusion criteria:

* Newly diagnosed patients (\< 3years) with type 2 diabetes.
* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
* No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

* History of lactic acidosis.
* Anemia (\<11g for males, \<10 g for females).
* Unstable or severe NY Heart Association-class 3 or 4.
* Any NY Heart Association congestive heart failure.
* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
D: Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes
* Body mass index (BMI) \>=22 to \<=45 kg/m2, at screening
* Patients must be taking a stable dosage of metformin as monotherapy at screening
* Patients must have a HbA1c between \>=7% and \<=9.5% at Week 2
* Patients must have a fasting plasma glucose (FPG) \<=270 mg/dL (15 mmol/L) at Week -2

Exclusion Criteria:

* Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
* History of diabetic ketoacidosis or type 1 diabetes mellitus
* History of pancreas or beta-cell transplantation
* History of active proliferative diabetic retinopathy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
* Taken thiazolidinedione therapy in the past 16 weeks before screening

Answer: A