Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

Exclusion Criteria

• •aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3X\*upper limit of normal (ULN)
• •Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
• •Creatinine kinase \>3\*ULN
• •Serum creatinine \>= 1.50 mg/dL (133 µmol/L) for male subjects, \>= 1.40 mg/dL (124 µmol/L) for female subjects
• •Calcium value outside of the central laboratory normal reference range
• •Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
• •Urine albumin:creatinine ratio (UACR) \>1800 mg/g (203.4 mg/mmol Cr)
• •Severe uncontrolled hypertension defined as systolic blood pressure (SBP) \>=180 mmHg and/or diastolic blood pressure (DBP) \>=110 mmHg
• •Hemoglobin \>=11.0 g/dL (110 g/L) for men; hemoglobin \>=10.0 g/dL (100 g/L) for women
• •Positive for hepatitis B surface antigen
• •Positive for anti-hepatitis C virus antibody
• •History of diabetes insipidus
• •History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• •Symptoms of poorly controlled diabetes that would preclude participation in this trial