Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
Eligibility criteria:
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