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Efficacy and safety of MYL‐1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study
Author(s) -
Blevins Thomas C.,
Barve Abhijit,
Sun Bin,
Raiter Yaron,
Aubonnet Patrick,
Muniz Rafael,
Athalye Sandeep,
Ankersen Michael
Publication year - 2019
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13495
Subject(s) - insulin glargine , medicine , insulin , glycated hemoglobin , clinical endpoint , diabetes mellitus , adverse effect , type 2 diabetes , endocrinology , hypoglycemia , randomized controlled trial , gastroenterology
Aims To assess the non‐inferiority of MYL‐1501D, a proposed biosimilar or follow‐on biological agent to marketed insulin glargine, to reference insulin glargine (Lantus®; Sanofi‐Aventis US LLC, Bridgewater, New Jersey) based on change in glycated hemoglobin (HbA1c). Materials and methods INSTRIDE 2 was a multicentre, open‐label, randomized, parallel‐group, phase III non‐inferiority study comparing the efficacy and safety of MYL‐1501D with those of reference insulin glargine in insulin‐naive and insulin‐non‐naive patients with type 2 diabetes mellitus receiving oral antidiabetic drugs (OADs). The primary efficacy endpoint was change in HbA1c from baseline to week 24. Secondary endpoints included metabolic readouts (eg, changes in fasting plasma glucose, insulin dosage, self‐monitored blood glucose), immunogenicity and adverse events, including hypoglycaemia and nocturnal hypoglycaemic events. Results In all, 560 patients were randomized to MYL‐1501D or insulin glargine in combination with OADs for 24 weeks. The mean change in HbA1c from baseline to week 24 was −0.60% (95% CI −0.78, −0.41) and − 0.66% (95% CI −0.84, −0.48) for MYL‐1501D and reference insulin glargine, respectively. MYL‐1501D was well tolerated and had a safety profile similar to that of reference insulin glargine. Conclusions Demonstration of non‐inferiority between MYL‐1501D and reference insulin glargine for reduction of HbA1c during 24 weeks of treatment was achieved. The two treatment groups were similar in terms of secondary endpoints, including hypoglycaemia and nocturnal hypoglycaemia, local and systemic reactions, other safety variables, and immunogenicity.