Our aim is to review previously disclosed data from a phase III study that compared LY2963016 insulin glargine (LY IGlar), the first biosimilar insulin approved in Australia, with IGlar in patients with T2DM.  Efficacy, safety, and patient-reported outcomes were evaluated in a 24-week, global, double-blind, randomised trial (ELEMENT-2) of LY IGlar (N=376) versus IGlar (N=380) once daily in combination with ≥2 oral antihyperglycaemic medications (OAMs).  Patients were either insulin-naïve (60%; starting dose 10 U/day) or on IGlar (starting = prestudy dose) and followed patient-driven titration (+1 unit daily) until fasting plasma glucose ≤5.6 mmol/L.  Results are presented as least squares mean [LSM; continuous data] using the last observation carried forward method; LY IGlar and IGlar, respectively.  Primary objective was to demonstrate non-inferiority (0.4% then 0.3%) of LY IGlar to IGlar by change in HbA1c from baseline to 24-week endpoint.  HbA1c changed by ‑1.29% and ‑1.34% (LSM difference [95%CI], 0.052% [-0.070%, 0.175%]).  As non-inferiority of IGlar to LY IGlar was also demonstrated, LY IGlar and IGlar were considered to have equivalent efficacy.  Other secondary outcomes (percent of patients reaching HbA1c<7.0%, 49% versus 53%; insulin dose, 0.50 versus 0.48 U/kg/day; body weight change, 1.8 versus 2.0 kg; daily mean blood glucose, 7.72 versus 7.83 mmol/L) were similar between treatment arms.  Safety profiles (total, nocturnal, severe hypoglycaemic events; adverse events) were similar between treatment arms.  Efficacy and safety profiles were also similar between LY IGlar and IGlar in subgroup analyses of patients who were insulin-naïve or on IGlar.  Patients using LY IGlar reported similar fear of hypoglycaemia and insulin treatment satisfaction as patients using IGlar.  In conclusion, LY IGlar compared with IGlar, both in combination with OAMs, provided equivalent efficacy, and similar safety profiles and patient-reported outcomes at 24-week endpoint with no clinically meaningful differences, in patients with T2DM.

Studies were sponsored by Eli Lilly and Company.