Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after 52 weeks: Results of the INSTRIDE 1 phase III study
Diabetes, Obesity and Metabolism May 25, 2018
Blevins TC, et al. - In INSTRIDE 1, a 52-week, open-label, randomized, phase III study, the researchers examined the safety and efficacy of MYL-1501D, a proposed insulin glargine biosimilar, in patients with type 1 diabetes mellitus (T1DM). According to the findings obtained, the upper 95% CI limit for mean change in glycated haemoglobin (HbA1c) at week 24 showed that MYL-1501D was non-inferior to reference insulin glargine. No clinically meaningful differences were found between groups in the incidence of overall and nocturnal hypoglycaemia, local or systemic reactions, safety or immunogenicity.
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