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

Autor:	Gopinath Ranganna, Yaron Raiter, Roxann Shapiro, Bin Sun, Thomas Blevins, Charles Donnelly, Laxmikant Vashishta, Anoop Chullikana, Anita U. Rao, Abhijit Barve
Rok vydání:	2021
Předmět:	Type 1 diabetes medicine.medical_specialty business.industry Endocrinology Diabetes and Metabolism medicine.disease Confidence interval Insulin aspart Safety profile Antibody response Diabetes mellitus Internal medicine Internal Medicine medicine Human insulin In patient business medicine.drug
Zdroj:	Diabetes. 70
ISSN:	1939-327X 0012-1797
Popis:	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. Disclosure 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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::7ea5213752dbd1354ce7e21296ffd2aa https://doi.org/10.2337/db21-741-p Zobrazit plný text záznamu