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

A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years

Inclusion criteria

• Provision of informed consent prior to any study-specific procedures
• Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
• Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
• HbA1c >= 6.5% and <= 11% obtained at screening visit
• 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
• FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit

Exclusion criteria

• Previous diagnosis of Type 1 diabetes
• Diabetes ketoacidosis (DKA) within 6 months of screening
• 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
• 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

• Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
• History of unstable or rapidly progressive renal disease
• History of unresolved vesico-ureteral reflux
• 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

• 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)
• Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
• An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
• Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
• 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
• 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