Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

Exclusion Criteria

• •1. Previous diagnosis of Type 1 diabetes
• •2. Diabetes ketoacidosis (DKA) within 6 months of screening
• •3. Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
• •* Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, or injectable incretins or incretin mimetics or other antidiabetes medications not otherwise specified
• •* Sixteen weeks: thiazolidinediones
• •* Any previous history or current use of an SGLT2 inhibitor, including dapagliflozin
• •4. Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening.
• •Use of prescription or non-prescription weight loss drugs must be stable during the study
• •5. Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
• •6. History of unstable or rapidly progressive renal disease
• •7. History of unresolved vesico-ureteral reflux
• •8. Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for \> 4 weeks within 3 months prior to the Day 1 visit.
• •Note: Topical, nasal, or inhaled corticosteroids are allowed
• •9. Abnormal renal function, which is defined in subjects \< 18 years of age as an estimated glomerular filtration rate (eGFR) calculated by the Schwartz Formula \< 80 mL/min/1.73 m2 (1.33 mL/s), and in subjects \>= 18 years as an estimated glomerular filtration rate (eGFR) calculated by the MDRD Formula \< 60 mL/min/1.73 m2 (1.33 mL/s)
• •10. Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
• •11. An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
• •12. Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
• •13. Anemia of any etiology defined as hemoglobin \<=10.7 g/dL (107 g/L) for females and \<= 11.3 g/dL (113 g/L) for males. Subjects who are considered to have anemia according to local guidelines should be excluded
• •14. Volume-depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics, should carefully monitor their volume status