Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus®) in Chinese adults with type 2 diabetes mellitus: A Phase III, randomised, open-label, controlled trial

Compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) versus insulin glargine (Lantus®; IGlar) combined with oral antihyperglycaemic medications (OAMs) in insulin-naive Chinese patients with type 2 diabetes mellitus (T2DM). In this Phase III, open-label trial, adult patients with T2DM receiving ≥2 OAMs at stable doses for ≥12 weeks with HbA1c ≥7.0 and ≤ 11.0% were randomised (2:1) to receive once-daily LY IGlar or IGlar, for 24 weeks. The primary outcome was non-inferiority of LY IGlar to IGlar at a 0.4% margin, and a gated secondary endpoint tested non-inferiority of IGlar to LY IGlar (-0.4% margin), assessed by least-squares (LS) mean change in HbA1c from Baseline to 24 weeks. Patients assigned to LY IGlar (n = 359) and IGlar (n = 177) achieved similar and significant reductions (P