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Review
. 2017 Jan;11(1):148-156.
doi: 10.1177/1932296816658055. Epub 2016 Jul 9.

Pharmacokinetic and Pharmacodynamic Properties of a Novel Inhaled Insulin

Lutz Heinemann  1 , Robert Baughman  2 , Anders Boss  3 , Marcus Hompesch  4
Affiliations
Review

Pharmacokinetic and Pharmacodynamic Properties of a Novel Inhaled Insulin

Lutz Heinemann et al. J Diabetes Sci Technol. 2017 Jan.

Abstract

Advances in insulin treatment options over recent decades have markedly improved the management of diabetes. Despite this, glycemic control remains suboptimal in many people with diabetes. Although postprandial glucose control has been improved with the development of subcutaneously injected rapid-acting insulin analogs, currently available insulins are not able to fully mimic the physiological time-action profile of endogenously secreted insulin after a meal. The delayed onset of metabolic action and prolonged period of effect induce the risk of postprandial hyperglycemia and late postprandial hypoglycemia. A number of alternative routes of insulin administration have been investigated over time in an attempt to overcome the limitations associated with subcutaneous administration and to provide an improved time-action insulin profile more closely simulating physiological prandial insulin release. Among these, pulmonary insulin delivery has shown the most promise. Technosphere® Inhaled Insulin (TI) is a rapid-acting inhaled human insulin recently approved by the FDA for prandial insulin therapy. In this article we discuss the pharmacokinetic and pharmacodynamic properties of TI, and, based on key studies performed during its clinical development, the implications for improved postprandial glucose control.

Keywords: inhaled insulins; insulin therapy; pharmacodynamics; pharmacokinetics; prandial insulin.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LH receives, or has received, funding from companies manufacturing insulin or developing novel insulins including Biodel, Eli Lilly, Halozyme, Novo Nordisk, and Sanofi. RB is an employee of MannKind Corporation. AB is an employee of Sanofi US, Inc. MH is an employee and shareholder at Profil Institute for Clinical Research.

Figures

Figure 1.
Figure 1.
Pharmacokinetics of TI administered using the Gen2 inhaler: mean (SE) C-peptide-corrected serum insulin concentration-time profiles in healthy subjects versus regular human insulin (Study 176) (A) and mean (SE) baseline-corrected serum insulin concentration over time profiles in subjects with type 1 diabetes, versus insulin lispro (Study 177) (B). IU, international units; SE, standard error.
Figure 2.
Figure 2.
Pharmacodynamics of TI: mean baseline-corrected glucose infusion rate of TI versus RAA in type 1 diabetes (Study 116).
Figure 3.
Figure 3.
Cumulative effect on glucose infusion rate of 8 U of TI and 10 IU of insulin lispro.
Figure 4.
Figure 4.
Pharmacodynamics of TI: mean baseline-corrected glucose infusion rate of TI versus regular human insulin in healthy subjects (Study 176).
Figure 5.
Figure 5.
Median EGP versus time after a meal challenge in subjects with type 2 diabetes. Source: Republished with permission of the American Diabetes Association from Potocka et al; permission conveyed through Copyright Clearance Center, Inc. Figure legend represents dosing per current TI cartridge labeling.
See this image and copyright information in PMC

References

    1. Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab. 2007;9:648-659. - PubMed
    1. Owens DR, Matfin G, Monnier L. Basal insulin analogues in the management of diabetes mellitus: What progress have we made? Diabetes Metab Res Rev. 2014;30:104-119. - PubMed
    1. Pettus J, Santos Cavaiola T, Tamborlane WV, Edelman S. The past, present, and future of basal insulins. Diabetes Metab Res Rev. 2016;32:478-96. - PubMed
    1. Heinemann L, Heise T, Wahl CH, et al. Prandial glycaemia after a carbohydrate-rich meal in type I diabetic patients using the rapid acting insulin analogue [Lys(B28), Pro(B29)] human insulin. Diabet Med. 1996;3:625-629. - PubMed
    1. Chen JW, Christiansen JS, Lauritzen T. Limitations to subcutaneous insulin administration in type 1 diabetes. Diabetes Obes Metab. 2003;5:223-233. - PubMed

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