Matches in SemOpenAlex for { <https://semopenalex.org/work/W2785389980> ?p ?o ?g. }
Showing items 1 to 89 of
89
with 100 items per page.
- W2785389980 endingPage "170" @default.
- W2785389980 startingPage "160" @default.
- W2785389980 abstract "Background: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog®; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both in combination with insulin glargine (Lantus®). SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this study, the impact of anti-insulin antibodies (AIA) to SAR-Lis and Ly-Lis on safety and glycemic control is reported. Methods: AIA 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 (HbA1c, insulin dose), was evaluated. Results: AIA 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 HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions or between efficacy/safety measures and subgroups by presence or absence of treatment-emergent AIA. Hypersensitivity events and events adjudicated as allergic reactions were few and did not differ between the two groups. Conclusion: Insulin lispro SAR342434 and the originator insulin lispro had a similar immunogenicity profile in people with T1DM or T2DM." @default.
- W2785389980 created "2018-02-23" @default.
- W2785389980 creator A5017097658 @default.
- W2785389980 creator A5027306477 @default.
- W2785389980 creator A5027624056 @default.
- W2785389980 creator A5065956182 @default.
- W2785389980 creator A5074505950 @default.
- W2785389980 creator A5085164369 @default.
- W2785389980 creator A5087844534 @default.
- W2785389980 date "2018-02-01" @default.
- W2785389980 modified "2023-10-18" @default.
- W2785389980 title "Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes" @default.
- W2785389980 cites W1551781971 @default.
- W2785389980 cites W1967295501 @default.
- W2785389980 cites W2038277294 @default.
- W2785389980 cites W2046974419 @default.
- W2785389980 cites W2098744538 @default.
- W2785389980 cites W2562943609 @default.
- W2785389980 cites W2737760301 @default.
- W2785389980 cites W2917193598 @default.
- W2785389980 doi "https://doi.org/10.1089/dia.2017.0373" @default.
- W2785389980 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/5771536" @default.
- W2785389980 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/29355435" @default.
- W2785389980 hasPublicationYear "2018" @default.
- W2785389980 type Work @default.
- W2785389980 sameAs 2785389980 @default.
- W2785389980 citedByCount "20" @default.
- W2785389980 countsByYear W27853899802018 @default.
- W2785389980 countsByYear W27853899802019 @default.
- W2785389980 countsByYear W27853899802020 @default.
- W2785389980 countsByYear W27853899802021 @default.
- W2785389980 countsByYear W27853899802022 @default.
- W2785389980 countsByYear W27853899802023 @default.
- W2785389980 crossrefType "journal-article" @default.
- W2785389980 hasAuthorship W2785389980A5017097658 @default.
- W2785389980 hasAuthorship W2785389980A5027306477 @default.
- W2785389980 hasAuthorship W2785389980A5027624056 @default.
- W2785389980 hasAuthorship W2785389980A5065956182 @default.
- W2785389980 hasAuthorship W2785389980A5074505950 @default.
- W2785389980 hasAuthorship W2785389980A5085164369 @default.
- W2785389980 hasAuthorship W2785389980A5087844534 @default.
- W2785389980 hasBestOaLocation W27853899801 @default.
- W2785389980 hasConcept C126322002 @default.
- W2785389980 hasConcept C134018914 @default.
- W2785389980 hasConcept C197934379 @default.
- W2785389980 hasConcept C2776486108 @default.
- W2785389980 hasConcept C2779306644 @default.
- W2785389980 hasConcept C2779920387 @default.
- W2785389980 hasConcept C2780473172 @default.
- W2785389980 hasConcept C2780668416 @default.
- W2785389980 hasConcept C2781232474 @default.
- W2785389980 hasConcept C555293320 @default.
- W2785389980 hasConcept C71924100 @default.
- W2785389980 hasConceptScore W2785389980C126322002 @default.
- W2785389980 hasConceptScore W2785389980C134018914 @default.
- W2785389980 hasConceptScore W2785389980C197934379 @default.
- W2785389980 hasConceptScore W2785389980C2776486108 @default.
- W2785389980 hasConceptScore W2785389980C2779306644 @default.
- W2785389980 hasConceptScore W2785389980C2779920387 @default.
- W2785389980 hasConceptScore W2785389980C2780473172 @default.
- W2785389980 hasConceptScore W2785389980C2780668416 @default.
- W2785389980 hasConceptScore W2785389980C2781232474 @default.
- W2785389980 hasConceptScore W2785389980C555293320 @default.
- W2785389980 hasConceptScore W2785389980C71924100 @default.
- W2785389980 hasIssue "2" @default.
- W2785389980 hasLocation W27853899801 @default.
- W2785389980 hasLocation W27853899802 @default.
- W2785389980 hasLocation W27853899803 @default.
- W2785389980 hasLocation W27853899804 @default.
- W2785389980 hasLocation W27853899805 @default.
- W2785389980 hasOpenAccess W2785389980 @default.
- W2785389980 hasPrimaryLocation W27853899801 @default.
- W2785389980 hasRelatedWork W2010274163 @default.
- W2785389980 hasRelatedWork W2063008961 @default.
- W2785389980 hasRelatedWork W2070806091 @default.
- W2785389980 hasRelatedWork W2102091953 @default.
- W2785389980 hasRelatedWork W2398280329 @default.
- W2785389980 hasRelatedWork W2417693226 @default.
- W2785389980 hasRelatedWork W2615893259 @default.
- W2785389980 hasRelatedWork W3031316986 @default.
- W2785389980 hasRelatedWork W4236767674 @default.
- W2785389980 hasRelatedWork W4240392880 @default.
- W2785389980 hasVolume "20" @default.
- W2785389980 isParatext "false" @default.
- W2785389980 isRetracted "false" @default.
- W2785389980 magId "2785389980" @default.
- W2785389980 workType "article" @default.