Women of childbearing potential unable or unwilling to use acceptable birth control

Women who are pregnant or breastfeeding

Fasting plasma glucose (FPG) \>270 mg/dL

Significant cardiovascular history

Symptoms of poorly controlled diabetes

History of diabetic ketoacidosis or hyperosmolar nonketotic coma

Insulin therapy within one year of screening

Cardiovascular even within the prior 6 months

New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction \<=40%

Significant history of renal or hepatic disease

History of a psychiatric disorder, alcohol or drug abuse within the previous year

Treatment with potent CYP3A4 inhibitors or inducers

Immunocompromised participants

Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus