ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2022
Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03338023 (A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus), which is not on this map. Cited by 1 paper.
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The trial behind it
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A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
- Adverse drug events associated with insulin glargine: a real-world pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2025Article
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionLY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product in Chinese patients with type 1 diabetes mellitus (T1DM) in the randomized, phase III ABES trial. This post hoc analysis aimed to provide the first evidence for switching from IGlar to LY IGlar in Chinese patients with T1DM.
methodsThis analysis included 210/272 patients with T1DM (77.2%) from the ABES trial who were receiving IGlar at screening. We compared antihyperglycemic efficacy, safety, and immunogenicity in patients randomized to LY IGlar (n = 104) versus those who continued to receive IGlar (n = 106).
resultsThere was no significant difference between groups in least-squares mean (LSMean) change in HbA1c from baseline to 24 weeks (LY IGlar - 0.10%, IGlar - 0.08%; LSMean difference [95% confidence interval] - 0.02% [- 0.24, 0.19]). At 24 weeks (last observation carried forward), a similar proportion of patients in each group achieved glycated hemoglobin less than 7.0% (LY IGlar 26.5%, IGlar 32.1%; P = 0.447) and 6.5% or less (LY IGlar 16.7%, IGlar 20.8%; P = 0.482). There were no significant differences between groups in LSMean of self-monitored blood glucose values, or total or basal insulin dose at 24 weeks. Patients in the LY IGlar and IGlar groups had a similar incidence of total hypoglycemia (blood glucose level 70 mg/dL or less, 91.4% vs. 92.5%) and treatment-emergent adverse events (AEs; 75.0% vs. 67.0%), and a low and similar incidence of serious AEs, injection site AEs, and allergic AEs. Similar proportions of patients in the LY IGlar and IGlar groups had treatment-emergent antibody responses (LY IGlar 27.2%, IGlar 28.3%) and detectable insulin antibodies (LY IGlar 52.4%, IGlar 53.8%).
conclusionIn Chinese patients with T1DM previously treated with IGlar, switching to LY IGlar for 24 weeks resulted in similar efficacy and safety outcomes as remaining on IGlar therapy. CLINICAL
trial registrationNCT03338023.
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