Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase 3 INSTRIDE 2 Study
Diabetes, Obesity and Metabolism Aug 23, 2018
Blevins TC, et al. - INSTRIDE 2 was a multicenter, open-label, randomized, parallel-group, phase 3 noninferiority study comparing safety as well as the efficacy of MYL-1501D with those of reference insulin glargine in insulin-naive and insulin–non-naive patients with type 2 diabetes mellitus (T2DM) receiving oral antidiabetic drugs (OADs). Researchers reported that demonstration of noninferiority between MYL-1501D and reference insulin glargine for lowering of glycosylated hemoglobin (HbA1c) during 24 weeks of treatment was achieved. Findings revealed that both treatment groups were comparable in terms of secondary endpoints, including hypoglycemia and nocturnal hypoglycemia, local and systemic reactions, other safety parameters, and immunogenicity. It was noted that MYL-1501D was well tolerated and had a safety profile comparable to that of reference insulin glargine.
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