Improving Efficacy of Inhaled Technosphere Insulin (Afrezza)
Jun 12, 2017 20:16:00 GMT -5
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m.4-traders.com/SANOFI-4698/news/Sanofi-New-Findings-on-Type-1-Diabetes-Mellitus-Described-by-Investigators-at-Sanofi-Aventis-Deuts-23522757/
Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing: In-silico Clinical Trial with the University of Virginia/Padova Type 1 Diabetes Simulator
Roberto Visentin
Clemens Giegerich
Robert Jäger
Raphael Dahmen
Anders Boss
Marshall Grant
Chiara Dalla Man
Claudio Cobelli
Thomas Klabunde
Address correspondence to:
Thomas Klabunde, PhD
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Building H831
Frankfurt am Main D-65926
E-mail: thomas.klabunde@sanofi.com
Diabetes Technology & Therapeutics
Vol. 18: Issue. 9: Pages. 574-585
(Issue publication date: September 2016)
doi.org/10.1089/dia.2016.0128
Abstract
Background: Technosphere® insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose. We used the University of Virginia (UVA)/Padova simulator to explore in-silico the potential benefit of different dosing regimens on postprandial glucose (PPG) control to support the design of further clinical trials. Tested dosing regimens included at-meal or postmeal dosing, or dosing before and after a meal (split dosing).
Methods: Various dosing regimens of TI were compared among one another and to insulin lispro in 100 virtual type-1 patients. Individual doses were identified for each regimen following different titration rules. The resulting postprandial glucose profiles were analyzed to quantify efficacy and the risk for hypoglycemic events.
Results: This approach allowed us to assess the benefit/risk for each TI dosing regimen and to compare results with simulations of insulin lispro. We identified a new titration rule for TI that could significantly improve the efficacy of treatment with TI.
Conclusion: In-silico clinical trials comparing the treatment effect of different dosing regimens with TI and of insulin lispro suggest that postmeal dosing or split dosing of TI, in combination with an appropriate titration rule, can achieve a superior postprandial glucose control while providing a lower risk for hypoglycemic events than conventional treatment with subcutaneously administered rapid-acting insulin products.
Introduction click to expand contents
Research Design and Methods click to expand contents
Results click to expand contents
Discussion click to expand contents
Author Disclosure Statement click to expand contents
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View PDF PLUS (713 KB)
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Mary Ann Liebert, Inc., publishers © 2017
Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing: In-silico Clinical Trial with the University of Virginia/Padova Type 1 Diabetes Simulator
Roberto Visentin
Clemens Giegerich
Robert Jäger
Raphael Dahmen
Anders Boss
Marshall Grant
Chiara Dalla Man
Claudio Cobelli
Thomas Klabunde
Address correspondence to:
Thomas Klabunde, PhD
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Building H831
Frankfurt am Main D-65926
E-mail: thomas.klabunde@sanofi.com
Diabetes Technology & Therapeutics
Vol. 18: Issue. 9: Pages. 574-585
(Issue publication date: September 2016)
doi.org/10.1089/dia.2016.0128
Abstract
Background: Technosphere® insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose. We used the University of Virginia (UVA)/Padova simulator to explore in-silico the potential benefit of different dosing regimens on postprandial glucose (PPG) control to support the design of further clinical trials. Tested dosing regimens included at-meal or postmeal dosing, or dosing before and after a meal (split dosing).
Methods: Various dosing regimens of TI were compared among one another and to insulin lispro in 100 virtual type-1 patients. Individual doses were identified for each regimen following different titration rules. The resulting postprandial glucose profiles were analyzed to quantify efficacy and the risk for hypoglycemic events.
Results: This approach allowed us to assess the benefit/risk for each TI dosing regimen and to compare results with simulations of insulin lispro. We identified a new titration rule for TI that could significantly improve the efficacy of treatment with TI.
Conclusion: In-silico clinical trials comparing the treatment effect of different dosing regimens with TI and of insulin lispro suggest that postmeal dosing or split dosing of TI, in combination with an appropriate titration rule, can achieve a superior postprandial glucose control while providing a lower risk for hypoglycemic events than conventional treatment with subcutaneously administered rapid-acting insulin products.
Introduction click to expand contents
Research Design and Methods click to expand contents
Results click to expand contents
Discussion click to expand contents
Author Disclosure Statement click to expand contents
View PDF (1397 KB)
View PDF PLUS (713 KB)
View Supplementary Material
SWIPE ACROSS ARTICLES
NEXT ARTICLE
Mary Ann Liebert, Inc., publishers © 2017