LY2963016 Insulin Glargine (LY IGlar) Compared with Lantus<sup>®</sup> Insulin Glargine (IGlar) in Patients with Type 1 Diabetes Mellitus (T1DM): Efficacy, Safety, and Patient-reported Outcomes from the ELEMENT-1 Study — ASN Events
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  3. LY2963016 Insulin Glargine (LY IGlar) Compared with Lantus® Insulin Glargine (IGlar) in Patients with Type 1 Diabetes Mellitus (T1DM): Efficacy, Safety, and Patient-reported Outcomes from the ELEMENT-1 Study

LY2963016 Insulin Glargine (LY IGlar) Compared with Lantus® Insulin Glargine (IGlar) in Patients with Type 1 Diabetes Mellitus (T1DM): Efficacy, Safety, and Patient-reported Outcomes from the ELEMENT-1 Study (#46)

Julio Rosenstock 1 , Jacek Kilijanski 2 , Liza Ilag 3 , Robyn Pollom 3 , Magaly Perez 3 , Dachuang Cao 3 , Lyndon Lacaya 3 , Jana Parkanyiova 4
  1. Dallas Diabetes and Endocrine Center, Medical City, Dallas, TX, United States
  2. Eli Lilly and Company, Poland
  3. Eli Lilly and Company, USA
  4. Eli Lilly and Company, Australia

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 T1DM.  Efficacy, safety, and patient-reported outcomes were evaluated in an open-label, randomised trial (ELEMENT-1) of LY IGlar (N=268) versus IGlar (N=267) once daily with mealtime insulin lispro for 24 weeks with a 28-week extension (24-week and 52-week endpoints).  Results are presented as least squares mean [LSM; continuous data] at study endpoints, using last observation carried forward method, and for LY IGlar and IGlar, respectively.  Primary objective was to demonstrate non-inferiority (0.4% then 0.3% margin) of LY IGlar to IGlar by change in HbA1c from baseline to 24-week endpoint.  HbA1c changed by ‑0.35% and ‑0.46% (LSM difference [95%CI], 0.108% [-0.002, 0.219]), thus meeting non-inferiority criteria.  As non-inferiority of IGlar to LY IGlar was also demonstrated, LY IGlar and IGlar were considered to have equivalent efficacy.  HbA1c change from baseline at 52-week endpoint (-0.26% versus -0.28%; LSM difference [95%CI], 0.020% [-0.099, 0.140]) and other secondary efficacy outcomes (daily mean blood glucose [24-week endpoint, 8.3 mmol/L both arms; 52-week endpoint, 8.3 versus 8.5 mmol/L], percent of patients reaching HbA1c<7.0% [24-week endpoint, 35% versus 32%; 52-week endpoint, 30% versus 25%], basal insulin dose [24-week endpoint, 0.37 versus 0.36 U/kg/day; 52-week endpoint, 0.38 versus 0.36 U/kg/day]) were similar between treatment arms.  Safety profiles (total, nocturnal, severe hypoglycaemic events; adverse events) were similar between treatment arms (both endpoints).  Patients using LY IGlar reported similar levels of fear of hypoglycaemia and insulin treatment satisfaction as patients using IGlar (both endpoints).  In conclusion, LY IGlar compared with IGlar, both with insulin lispro, provided equivalent efficacy, and similar safety profiles and patient-reported outcomes at 24- and 52-week endpoints with no clinically meaningful differences, in patients with T1DM.

Studies were sponsored by Eli Lilly and Company.