This decision was based on the results of two Phase III clinical trials of the DEPICT clinical program (Dapagliflozin in Patients with Inadequately Controlled type 1 diabetes mellitus), which demonstrated that dapagliflozin associated with insulin significantly reduced glycated hemoglobin (HbA1c), weight, and total daily insulin dose in T1DM patients not adequately controlled [6]. This evidence concerns the gene INS and diabetes mellitus.