Pharmacodynamic and pharmacokinetic evaluation of insulin glargine U300 for the treatment of type 1 diabetes.

INTRODUCTION: Glargine 300 units/ml (Gla-300) is a novel basal insulin formulation approved in 2015 for the treatment of diabetes. This more concentrated form of glargine causes delayed redissolution from the subcutaneous depot after injection and thus altered action profile. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of Gla-300 in patients with type 1 diabetes mellitus (T1DM) will be reviewed. Expert opinion: Gla-300 has a flatter and more prolonged pharmacokinetic profile compared to glargine 100 units/ml (Gla-100), but is less potent on a unit per unit basis. The prolonged duration of Gla-300 should provide 24h coverage with a single daily dose in all patients. Two phase III trials comparing Gla-300 and Gla-100 were conducted in patients with T1DM. A1C reduction and other measures of glycemic control were similar between groups. Hypoglycemia rates were similar among groups in one trial, but favored Gla-300 in the other. Evidence for improvement in hypoglycemia with Gla-300 is more convincing in the type 2 diabetes population. Gla-300 is available in an insulin pen to mitigate potential dosing errors with different glargine concentrations; the maximum dose per injection is 80 units. Future research should include direct comparison with degludec and use in insulin-resistant populations.