Similar pharmacokinetic (PK) exposure and pharmacodynamic (PD) activity were demonstrated for SAR-Lis to both Ly-Lis approved in the EU and Ly-Lis approved in the US, as well as between Ly-Lis US and Ly-Lis EU in a PK/PD study in patients with T1DM using the euglycemic clamp technique.9,10 This report presents the results of a multinational, open-label, randomized, controlled Phase 3 study (SORELLA 2) comparing the efficacy and safety of SAR-Lis and the reference product Ly-Lis (100 U/mL) in patients with T2DM, also using insulin glargine (GLA-100). Here, INS is linked to type 2 diabetes mellitus.