Similar Efficacy and Safety of Basaglar® and Lantus® in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study

Abstract

IntroductionTo compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA IGlar)] in older (≥ 65 years) or younger (< 65 years) patients with type 2 diabetes (T2D).MethodsThis subgroup analysis of a phase 3, randomized, double-blind, multinational, 24-week study compared LY IGlar and SA IGlar on several clinical efficacy (change in glycated hemoglobin (A1c), basal insulin dose, weight) and safety outcomes (incidence of adverse events, insulin antibodies, hypoglycemia incidence and rates) in patients either ≥ 65 or < 65 years.ResultsCompared with patients aged < 65 years (N = 542), patients aged ≥ 65 years (N = 214) had a significantly longer duration of diabetes; lower baseline A1c and body weight; and body mass index; and were more likely to report prestudy SA IGlar use. Compared to patients < 65 years, patients ≥ 65 years needed a lower basal insulin dose and experienced lower body weight gain. There were no significant treatment-by-age interactions for the clinical efficacy and safety outcomes, indicating that there was no differential treatment effect (LY IGlar vs SA IGlar) for patients ≥ 65 years vs those < 65 years. Moreover, within each age subgroup, LY IGlar and SA IGlar were similar for all clinical efficacy and safety outcomes.ConclusionsLY IGlar and SA IGlar exhibit similar efficacy and safety in patients with T2D who are ≥ 65 years and in those < 65 years.Trial RegistrationClinicalTrials.gov trial registration: NCT01421459.FundingEli Lilly and Company and Boehringer-Ingelheim.

Lilly Insulin Glargine Versus Lantus® in Insulin-Naïve and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5)

“…Thus, nonclinical and clinical studies comparing similar biologics with their reference products must demonstrate similar structural and functional characteristics and clinically similar outcomes, as required by regulatory agencies [ 18 – 23 ]. Several such studies were conducted as part of the LY IGlar development program [ 24 – 33 ]. Assessment of outcome effects across different racial backgrounds and clinical characteristics, such as prior insulin exposure, is also important as further characterization of the extent of effect comparability.…”

Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes

“…The selected period of study was based on other insulin glargine immunogenicity studies, such as Basaglar and MYL-1501D. [13][14][15] This study recruited 133 insulin-naïve patients with T2D from three hospitals across Jakarta, Indonesia. We included patients who were not adequately controlled with oral antidiabetic medications, as proven with HbA1c of >7.0%.…”

“…While another study was using insulin, glargine was started at HbA1c of 8%. [13][14][15]17 We used two markers of immunogenicity to exogenous insulin: IAA and ZnT8. ZnT8 is a protein that is highly expressed in beta cells.…”

An exploratory analysis of the cost‐effectiveness of insulin glargine 300 units/mL versus insulin glargine 100 units/mL over a lifetime horizon using the BRAVO diabetes model

“…19 The ELEMENT-2 study demonstrated that the originator and biosimilar are associated with similar efficacy and safety in people with T2D. 24 A scenario analysis using treatment costs for a biosimilar Gla-100 demonstrated Gla-300 as the dominant treatment option for people with T2D. As all tested scenarios yielded a positive NMB, the base case analysis can be considered a conservative assumption.…”