Visual Abstract
MYL-1601D is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing Pichia pastoris yeast. This was a randomized, multicenter, open-label, parallel-group study to compare the safety and efficacy of MYL-1601D with NovoLog in T1DM patients. The primary objective was to demonstrate that treatment emergent antibody response (TEAR) rate with MYL-1601D was equivalent to that of NovoLog by achieving the 90% confidence interval (CI) of treatment difference within the prespecified margin (-12%, +12%) during 24week treatment. The study also compared MYL-1601D to NovoLog, change from baseline to week 24, for the parameters provided in the below Table 1. In total, 478 subjects were included in the intent-to-treat analysis (MYL-1601D: 238, NovoLog: 240) of which, 59 (24.9%) in MYL-1601D and 67 (27.8%) in NovoLog were TEAR responders. The study met its primary objective by showing that the TEAR rate was equivalent between the insulins (the 90% confidence interval difference was within the prespecified margin of -12%, +12%) during 24 weeks of treatment. Efficacy and safety parameters were similar between the two treatment groups. Overall, the study confirmed that MYL-1601D has a similar immunogenicity, efficacy and safety profile to NovoLog.
Y. Raiter: Employee; Self; Mylan N. V. A. Barve: Employee; Self; Mylan N. V., Stock/Shareholder; Self; Biocon. T. Blevins: Advisory Panel; Self; Lilly Diabetes, Research Support; Self; Allergan plc, Lilly Diabetes, Medtronic, Mylan N. V., Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk. B. Sun: Employee; Self; Mylan N. V., Stock/Shareholder; Self; Mylan N. V. C. M. Donnelly: Employee; Self; Mylan N. V., Viatris Inc. A. U. Rao: None. R. Shapiro: None. L. Vashishta: None. G. Ranganna: Employee; Self; Mylan N. V., Viatris. A. Chullikana: Employee; Self; Biocon.
