Study to evaluate safety and efficacy of Dapagliflozin in patients with type 2 diabetes mellitus aged 10-24 years

Exclusion Criteria

• Inclusion Criteria
• 1. Provision of informed consent prior to any study-specific procedures
• 2. Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
• 3. Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
• 4. HbA1c >= 6.5% and <= 11% obtained at screening visit
• 5. Currently on diet and exercise and a stable dose of metformin (at least 1000 mg daily) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of metformin (at least 1000 mg daily) and insulin for a minimum of 8 weeks prior to screening
• 6. FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit
• 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