Phase III study shows LY 2963016 equivalent to Lantus - Eli Lilly/Boehringer

Eli Lilly and Boehringer presented Phase III data showing that LY 2963016 (insulin glargine biosimilar) has a similar safety and efficacy profile to currently marketed Lantus (insulin glargine). In patients with Type 1 and 2 Diabetes, LY 2963016 insulin glargine demonstrated non-inferiority compared to marketed insulin glargine, and marketed insulin glargine demonstrated non-inferiority to LY 2963016 insulin glargine. Patients with Type 1 Diabetes had HbA1c reductions of -0.4 percent (LY 2963016 insulin glargine) and -0.5 percent (marketed insulin glargine) at 24 weeks, with similar results at 52 weeks (-0.3 percent for both insulin glargine treatments). Patients with T2D had HbA1c reductions of -1.3 percent in both insulin glargine treatment groups at 24 weeks.

Approximately one-third of T1D patients reached target HbA1c levels of less than 7 percent at 24 weeks with LY 2963016 insulin glargine (35 percent) and marketed insulin glargine (32 percent) treatment. About half of T2D patients reached these target levels with LY 2963016 insulin glargine (49 percent) and marketed insulin glargine (53 percent) treatment. The frequency of adverse events was similar between the two treatments in both sets of patients. Results also showed a similar immunogenicity profile of LY 2963016 insulin glargine to marketed insulin glargine. Results from these studies were presented at the 74th American Diabetes Association Scientific Sessions.