Safety and Efficacy of Dapagliflozin in Asian T2DM subjects with Inadequate glycemic control on Metformin/Saxagliptin

Exclusion Criteria

• 1. Women of childbearing potential unable or unwilling to use acceptable birth control, or women who are pregnant or breastfeeding
• 2. History of diabetes insipidus and type 1 diabetes
• 3. History of diabetic ketoacidosis requiring medical intervention within 1 month prior to screening
• 4. Subjects with moderate to severe renal impairment (defined as estimate glomerular filtration rate calculated by the MDRD Formula < 60mL/min/1.73 m^2 or serum creatinine ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females) or end-stage renal disease
• 5. History of unstable or rapidly progressing renal disease
• 6. Subjects with significant hepatic disease or severe hepatic impairment, or positive serologic evidence of current infectious liver disease
• 7. Prohibited Treatment and Therapies
• - Administration of any anti-hyperglycemic therapy [other than metformin, or Dipeptidyl peptidase-4 (DPP-4) inhibitors] for more than 14 days (consecutive or not) during the 8 weeks prior to screening
• - Any use of Sodium glucose cotransporter 2 (SGLT2) inhibitor within 8 weeks prior to screening
• - Prescription and over-the-counter weight loss medications within 3 months prior to screening
• - Current treatment with potent cytochrome P450 3A4/5 inhibitors
• 8. Malignancy within 5 years of the screening
• 9. History of hemoglobinopathy
• 10. Hematuria (by microscopy) positive at screening visit
• 11. FPG > 270 mg/dL obtained at open-label period
• 12. An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded