Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)

Exclusion Criteria

• •History of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD (Glutamic Acid Decarboxylase) or (Islet cell autoantigen) ICA-512.
• •Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
• •Symptomatic hyperglycemia and/or moderate to large ketonuria and/or positive test for ketonemia requiring immediate initiation of antihyperglycemic therapy.
• •Previously taken a DPP-4 (Dipeptidyl peptidase-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 (Glucagon-like peptide-1) receptor agonist (such as exenatide or liraglutide).
• •Hypersensitivity or contraindication (according to the product circular in the country of the investigational site) to metformin.
• •Chronic treatment with a medication known to cause weight gain within 30 days of study start or weight loss or increased blood glucose within 8 weeks of study start or treated with an anti-psychotic within the past 12 weeks.
• •On a weight loss program and not in the maintenance phase or have undergone bariatric surgery within 12 months prior to study start.
• •On or likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
• •Undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study.
• •History of congenital heart disease or cardiovascular disease other than hypertension.
• •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.
• •Active nephropathy (i.e., nephrotic syndrome or glomerulonephritis).
• •Chronic myopathy, mitochondrial disorder, or a progressive neurological or neuromuscular disorder (e.g., polymyositis, or multiple sclerosis).
• •Human immunodeficiency virus (HIV) as assessed by medical history.
• •Clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndrome).
• •Under treatment for hyperthyroidism.
• •Exhibits abnormal growth patterns or is being treated with growth hormone.
• •History of malignancy or clinically important hematologic disorder.
• •History of idiopathic acute pancreatitis or chronic pancreatitis.
• •Known history of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year).
• •Donated blood products or has had phlebotomy of \>10% of estimated total blood volume within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study.
• •Pregnant, has a positive urine pregnancy test at Screening Visit/Visit 1, is expecting to conceive within the projected duration of the study, or is breast-feeding.
• •Exclusionary laboratory values.