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The FDA has approved Basaglar (Lilly/Boehringer Ingelheim), a "follow-on" 100 units/mL insulin glargine product similar to Lantus (Sanofi), which recently went off patent. A 300 units/mL formulation of insulin glargine (Toujeo) was approved in 2015.1
INSULIN GLARGINE — A recombinant DNA analog of human insulin, insulin glargine forms microprecipitates in subcutaneous tissue, prolonging its duration of action to a mean of about 24 hours.2 It has less peak-to-trough variation and causes less nocturnal hypoglycemia than NPH insulin.
CLINICAL STUDIES — Approval of Basaglar was based on data demonstrating the clinical efficacy and safety of Lantus.3 Comparative studies have found no significant differences in the pharmacokinetics, toxicity,... more
- Concentrated insulin glargine (Toujeo) for diabetes. Med Lett Drugs Ther 2015; 57:69.
- Drugs for diabetes. Med Lett Drugs Ther 2017; 59:9.
- Center for Drug Evaluation and Research. Basaglar Summary Review. Available at: www.accessdata.fda.gov. Accessed December 20, 2016.
- H Linnebjerg et al. Comparison of the pharmacokinetics and pharmacodynamics of LY2963016 insulin glargine and EU- and US-approved versions of Lantus insulin glargine in healthy subjects: three randomized euglycemic clamp studies. Diabetes Care 2015; 38:2226.
- LL Ilag et al. Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus insulin glargine in patients with type 1 or type 2 diabetes mellitus. Diabetes Obes Metab 2016; 18:159.
- TC Blevins et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab 2015; 17:726.
- J Rosenstock et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus) in patients with type 2 diabetes who were insulin-naive or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab 2015; 17:734.