| Autor: |
Thomas C, Blevins, Yaron, Raiter, Bin, Sun, Charles, Donnelly, Roxann, Shapiro, Anoop, Chullikana, Anita, Rao, Laxmikant, Vashishta, Gopinath, Ranganna, Abhijit, Barve |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. 36(6) |
| ISSN: |
1179-190X |
| Popis: |
MYL-1601D is a proposed biosimilar of originator insulin aspart, NovologThis study assessed the immunogenicity, efficacy, and safety of MYL-1601D with Ref-InsAsp-US in patients with type 1 diabetes mellitus (T1D).This was a 24-week, open-label, randomized, phase III study. Patients were randomized 1:1 to mealtime MYL-1601D or Ref-InsAsp-US in combination with insulin glargine (Lantus SoloSTARIn total, 478 patients were included in the intent-to-treat analysis (MYL-1601D: 238; Ref-InsAsp-US: 240) set. The 90% confidence interval (CI) for the primary endpoint was within the pre-defined equivalence margin of ±11.7% and the treatment differences (SE) in TEAR responders between the treatment groups was - 2.86 (4.16) with 90% CI - 9.71 to 3.99. The mean (SD) changes from baseline for HbA1c, FPG, and insulin dosages were similar in both groups at week 24. The safety profiles including hypoglycemia, immune-related events, AEs, and other reported variables were similar between the treatment groups at week 24.MYL-1601D demonstrated similar immunogenicity, efficacy, and safety profiles to Ref-InsAsp-US in patients with T1D over 24 weeks. CLINICAL TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03760068. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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