Lilly Insulin Glargine Versus Lantus in Insulin-Naïve and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5).

Introduction: This study compared the efficacy and safety of similar U-100 insulin glargine products, namely, Lilly insulin glargine (LY IGlar; Basaglar) and the reference insulin glargine product (IGlar; Lantus), used once daily in combination with oral antihyperglycemic medications (OAMs) in adults with type 2 diabetes (T2D).

Methods: ELEMENT 5 was a phase III, randomized, multinational, open-label, treat-to-target, 24-week trial. Participants were insulin naïve (glycated hemoglobin [HbA1c] ≥ 7.