Trial reportDiabetes technology & therapeutics2018
Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes.
Trial report in Diabetes technology & therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.PloS one · 2018Pooled it
- Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (NovologBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Trial
- Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.BMC endocrine disorders · 2021Trial
- 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 between glucose-lowering drugs and circulating insulin antibodies induced by insulin therapy in patients with type 2 diabetes.World journal of diabetes · 2024Article
- Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials.Journal of diabetes science and technology · 2023Review
- An Institutional Guide for Formulary Decisions of Biosimilars.Hospital pharmacy · 2023Review
- Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary.Clinical pharmacology and therapeutics · 2023Review
- 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
- Influence of Insulin Receptor Single Nucleotide Polymorphisms on Glycaemic Control and Formation of Anti-Insulin Antibodies in Diabetes Mellitus.International journal of molecular sciences · 2022Article
- Biosimilar insulin concepts.Journal of diabetes · 2022Article
- Analysis of the Outcomes of 73 Patients with Exogenous Positive Insulin Anti-Body.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022Article
- Association of Higher Circulating Insulin Antibody with Increased Mean Amplitude Glycemic Excursion in Patients with Type 2 Diabetes Mellitus: A Cross-Sectional, Retrospective Case-Control Study.Journal of diabetes research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog
methodsAIA were measured regularly throughout both studies at a centralized laboratory blinded to treatment groups using a drug-specific AIA assay. The AIA status (positive or negative), AIA titers, and cross-reactivity to human insulin, insulin glargine, and insulin glargine metabolite M1 were analyzed. The potential effect of AIA on safety, particularly as related to hypersensitivity reactions, hypoglycemia, and treatment-emergent adverse events, as well as on glycemic control (HbA
resultsAIA positive status at baseline was similar for the two insulins, but higher in T1DM than in T2DM. In both studies, the percentage of people newly developing AIA in the two treatment groups, or having a ≥4-fold increase in AIA titers, did not differ. No relationship was observed between maximum individual AIA titers and change in HbA
conclusionInsulin lispro SAR342434 and the originator insulin lispro had a similar immunogenicity profile in people with T1DM or T2DM.
Indexed as
Identifiers
What Socratic holds
Registered trials
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 Socratic graph.