The efficacy and safety of LY2963016 among patients with Type 1 and Type 2 diabetes previously treated with insulin glargine

Introduction: We evaluated the treatment effect of LY2963016 insulin glargine (LY IGlar) as compared to insulin glargine (Sanofi-Aventis; IGlar) in a subgroup of patients who reported prestudy treatment with IGlar (prior IGlar) for Type 1 diabetes and Type 2 diabetes in 52-week open-label (ELEMENT-1) and 24-week double-blind (ELEMENT-2) randomised studies.

Methods: Both studies used unit-to-unit dose conversions from prestudy IGlar to study LY IGlar or IGlar then treat-to-target titration. Primary efficacy (defined as change in HbA1c from baseline to the 24-week endpoint), other efficacy, and select safety outcomes of LY IGlar were compared with IGlar for the prior IGlar subgroup (ELEMENT-1: n = 452; ELEMENT-2: n = 299). Continuous data were analysed using ANCOVA. Treatment comparisons for hypoglycaemia rate were done using the Wilcoxon test. Fisher's exact test or chi-square test was used for categorical data.

Results: No significant treatment differences (p > 0.05) were observed for primary and other efficacy outcomes, including proportion of patients achieving endpoint HbA1c targets, basal insulin dose and prandial insulin dose (ELEMENT-1 only). No significant treatment differences (p > 0.05) were observed for safety outcomes, including total and nocturnal hypoglycaemia rates and incidences (endpoint and overall; BG≤3.9 mmol/l if available), incidence of treatment-emergent adverse events and detectable antibody levels (% binding). A small but statistically significant treatment difference existed for weight change from baseline in ELEMENT-1 (LY IGlar-IGlar LS mean difference; 0.781 kg; p =.016) but not in ELEMENT-2.

Conclusions: Among patients who reported prestudy treatment with IGlar, those randomised to LY IGlar had similar efficacy and safety outcomes as those randomised to IGlar.