Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2

Background:This analysis evaluates the patient-reported outcomes (PROs) in two randomized studies of biosimilar LY2963016 insulin glargine (LY IGlar) and Lantus[R] insulin glargine (IGlar), when used in combination with mealtime insulin lispro in patients with type 1 diabetes mellitus (T1 DM) or oral anti-hyperglycaemics in patients with type 2 diabetes mellitus (T2DM). Methods: Patients with T1 DM on basal-bolus insulin therapy were randomized to receive once-daily LY IGlar or IGlar in combination with mealtime insulin lispro for 52 weeks (ELEMENT 1) or patients with T2DM on oral agents with or without previous basal insulin were randomized to receive once-daily LY IGlar or IGlar for 24weeks (ELEMENT 2). PROs assessed included Insulin Treatment Satisfaction Questionnaire (ITSQ) and the Adult Low Blood Sugar Survey (ALBSS). Results: In ELEMENT 1 (LY IGlar, n = 268; IGlar, n = 267) and ELEMENT 2 (LY IGlar, n = 376; IGlar, n = 380), there were no statistically significant between-group differences in either trial on the ITSQ or ALBSS. In ELEMENT 1, patients in both treatment groups demonstrated improvements from baseline in all domains and total scores with significant improvements in ITSQ inconvenience of regimen, glycaemic control, insulin device satisfaction domains, and total transformed score; patients using LY IGlar had significant improvements in ALBSS total score. In ELEMENT 2, both treatment arms showed significant improvements in the ITSQ and glycaemic control domains, and LY IGlar also showed significant improvements in the ALBSS behaviour subscale. Conclusion: Findings demonstrated that patients with T1 DM and T2DM receiving LY IGlar reported similar levels of insulin treatment satisfaction and fear of hypoglycaemia as patients using IGlar. Keywords: Biosimilar, follow-on biological, glargine, patient-reported outcomes, type 1 diabetes mellitus, type 2 diabetes mellitus