Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2022
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03760068 (A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Low immunogenicity of insulin efsitora alfa in participants with type 1 and type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2026Pooled it
- Trends in baseline HbA1c and body-mass index in randomised trials of people with type 1 diabetes from 1993 to 2025: an IMI2 SOPHIA systematic review and meta-analysis.EClinicalMedicine · 2025Article
- Biosimilar insulins: Narrative review of the regulatory framework and registration studies.Diabetes, obesity & metabolism · 2025Review
- Efficacy, safety, and immunogenicity of recombinant insulin aspart (BioGenomics Limited) and NovoRapidResearch in pharmaceutical sciences · 2024Article
- Association of subclass distribution of insulin antibody with glucose control in insulin-treated type 2 diabetes mellitus: a retrospective observational study.Frontiers in endocrinology · 2023Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMYL-1601D is a proposed biosimilar of originator insulin aspart, Novolog
objectiveThis study assessed the immunogenicity, efficacy, and safety of MYL-1601D with Ref-InsAsp-US in patients with type 1 diabetes mellitus (T1D).
methodsThis 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 SoloSTAR
resultsIn 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.
conclusionsMYL-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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.