741-P: Efficacy and Safety of MYL-1601D (Mylan's Insulin Aspart) Compared with Novolog (Novo Nordisk's Insulin Aspart) in Patients with Type 1 Diabetes (T1DM) after 24 Weeks
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 de...
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Published in | Diabetes (New York, N.Y.) Vol. 70; no. Supplement_1 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
New York
American Diabetes Association
01.06.2021
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Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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ISSN: | 0012-1797 1939-327X |
DOI: | 10.2337/db21-741-P |