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Clinical Pharmacokinetics and Pharmacodynamics of Insulin Glargine 300 U/mL

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Abstract

Concentrated insulin analogs have recently been approved and are available for clinical use in the management of diabetes mellitus. One new product is insulin glargine U-300 (Sanofi), a basal concentrated insulin of 300 U/mL. Several studies have been conducted and completed evaluating blood samples for the pharmacokinetics of insulin glargine U-300 and euglycemic clamp procedures for the pharmacodynamics. This concentrated insulin has a low within-day variability and high day-to-day reproducibility, allowing for a more constant and prolonged duration of action, compared with insulin glargine U-100 (100 U/mL). Insulin glargine U-300 is equally effective, when compared with insulin glargine U-100 for glycemic control in patients with type 1 and 2 diabetes mellitus. Insulin glargine U-300 has a similar efficacy profile to insulin glargine U-100 for glycemic control, yet with lower rates of nocturnal and severe hypoglycemia. Insulin glargine U-300 can be considered an acceptable basal insulin for patients with type 1 and 2 diabetes mellitus, and it has a potential role among patients who are naïve to insulin therapy or require titration of basal insulin. Titration of insulin glargine U-300 would result in less volume and a lower risk of hypoglycemia, compared with insulin glargine U-100. This article evaluates and summarizes the pharmacokinetics and pharmacodynamics of insulin glargine U-300, for patients with type 1 or 2 diabetes mellitus, and summarizes its application to clinical practice.

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Correspondence to Jennifer N. Clements.

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No external funding was used in the preparation of this manuscript.

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JN Clements, T Threatt, E Ward, and KM Shealy declare they have no conflicts of interest that might be relevant to the contents of this manuscript.

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Clements, J.N., Threatt, T., Ward, E. et al. Clinical Pharmacokinetics and Pharmacodynamics of Insulin Glargine 300 U/mL. Clin Pharmacokinet 56, 449–458 (2017). https://doi.org/10.1007/s40262-016-0464-6

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