Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

Exclusion Criteria

• - Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
• - History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• - Women of childbearing potential unable or unwilling to use acceptable birth control
• - Women who are pregnant or breastfeeding
• - Active liver disease
• - Anemia
• - Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
• - Use of short- or rapid-acting insulin
• - Significant cardiovascular history defined as: myocardial
• infarction, coronary angioplasty or bypass graft, valvular disease or repair,
• unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
• - Congestive heart failure
• - Unstable or rapidly progressing renal disease
• - History of alcohol or drug abuse within the previous year
• - History of hemoglobinopathies
• - Unstable major psychiatric disorders
• - Immunocompromised status