Trial reportDiabetes technology & therapeutics2018
Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.
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. It is linked to trial NCT02294474 (Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine), which is not on this map. Cited by 11 papers, 2 of them syntheses 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.
Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis.BMC endocrine disorders · 2022Pooled it
- Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.PloS one · 2018Pooled it
- Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan-Approved Humalog Insulin Lispro in Healthy Japanese Subjects.Clinical pharmacology in drug development · 2022Trial
- Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump.Journal of diabetes science and technology · 2018Trial
- Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes.Diabetes technology & therapeutics · 2018Trial
- Exploring Stakeholder Perceptions and Experience of Biosimilar Insulin Switching: A Scoping Review.Endocrinology, diabetes & metabolism · 2026Article
- Biosimilar insulins: Narrative review of the regulatory framework and registration studies.Diabetes, obesity & metabolism · 2025Review
- An Institutional Guide for Formulary Decisions of Biosimilars.Hospital pharmacy · 2023Review
- Biosimilar insulin concepts.Journal of diabetes · 2022Article
- Update on Biosimilar Insulins: A US Perspective.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- [Insulin therapy-new insulin analogues].Der Internist · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog
methodsSORELLA 2 was a 6-month, randomized, open-label, Phase 3 study (NCT02294474). Insulin doses were adjusted to achieve fasting and 2-h postprandial glucose targets according to American Diabetes Association guidelines. Primary endpoint was the HbA
resultsA total of 505 patients were randomized (1:1) to multiple daily injections of SAR-Lis (n = 253) or Ly-Lis (n = 252) plus once-daily GLA-100. Least square (LS) mean (standard error) change in HbA
conclusionsResults from this controlled study in patients with T2DM also using GLA-100 support similar efficacy and safety (including immunogenicity) of SAR-Lis and Ly-Lis.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.