Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing: In-silico Clinical Trial with the University of Virginia/Padova Type 1 Diabetes Simulator

Diabetes Technology and Therapeutics

Volumn 18, Issue 9, 2016, Pages 574-585

  Visentin, Roberto ^a   Giegerich, Clemens ^b   Jäger, Robert ^b   Dahmen, Raphael ^b   Boss, Anders ^c   Grant, Marshall ^d   Dalla Man, Chiara ^a   Cobelli, Claudio ^a   Klabunde, Thomas ^b  

^a UNIVERSITY OF PADOVA   (Italy)

^b SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^c SANOFI   (France)

^d MannKind Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; INSULIN LISPRO; RECOMBINANT HUMAN INSULIN; ANTIDIABETIC AGENT; INSULIN;

ADULT; ARTICLE; CLINICAL ARTICLE; COMPARATIVE STUDY; COMPUTER MODEL; CONTROLLED STUDY; DRUG DOSE TITRATION; DRUG EFFICACY; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN HYPOGLYCEMIA; INSULIN TREATMENT; MALE; PHASE 3 CLINICAL TRIAL; POSTPRANDIAL STATE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SIMULATOR; TREATMENT OUTCOME; COMPUTER SIMULATION; DIABETES MELLITUS, TYPE 1; DRUG ADMINISTRATION; INHALATIONAL DRUG ADMINISTRATION;

ADMINISTRATION, INHALATION; COMPUTER SIMULATION; DIABETES MELLITUS, TYPE 1; DRUG ADMINISTRATION SCHEDULE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; POSTPRANDIAL PERIOD;

EID: 84987728090     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2016.0128     Document Type: Article

References (17)

1. Morris A, Boyle DI, McMahon AD, et al.: Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. The DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland. Medicines Monitoring Unit. Lancet 1997;350: 1505-1510.
2. Leone-Bay A, Grant M: Technosphere/insulin: mimicking endogenous insulin release. In: Rathbone M, Hadgraft J, Roberts M, Lane M, eds. Modified-Release Drug Delivery Technology, Vol. 2, 2nd ed. New York: Informa Healthcare USA, Inc., 2008, pp. 673-679.
3. Boss AH, Petrucci R, Lorber D: Coverage of prandial insulin requirements by means of an ultra-rapid-acting inhaled insulin. J Diabetes Sci Technol 2012;6:773-779.
4. Richardson PC, Boss AH: Technosphere insulin technology. Diabetes Technol Ther 2007;9(Suppl. 1):S65-S72
5. Bode BW, McGill JB, Lorber DL, et al.; Affinity 1 Study Group: Inhaled technosphere insulin compared with injected prandial insulin in type 1 diabetes: a randomized 24- week trial. Diabetes Care 2015;38:2266-2273.
6. Kovatchev BP, Breton M, Dalla Man C, Cobelli C: In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J Diabetes Sci Technol 2009;3: 44-55.
7. Dalla Man C, Micheletto F, Lv D, et al.: The UVA/ PADOVA type 1 diabetes simulator: new features. J Diabetes Sci Technol 2014;8:26-34.
8. Visentin R, Klabunde T, Grant M, et al.: Incorporation of inhaled insulin into the FDA accepted University of Virginia/ Padova Type 1 Diabetes Simulator. Conf Proc IEEE Eng Med Biol Soc 2015;2015:3250-3253.
9. Visentin R, Dalla Man C, Kovatchev B, Cobelli C: The University of Virginia/Padova type 1 diabetes simulator matches the glucose traces of a clinical trial. Diabetes Technol Ther 2014;16:428-434.
10. Dalla Man C, Raimondo DM, Rizza RA, Cobelli C: GIM, simulation software of meal glucose-insulin model. J Diabetes Sci Technol 2007;1:323-330.
11. Potocka E, Baughman RA, Derendorf H: Population pharmacokinetic model of human insulin following different routes of administration. J Clin Pharmacol 2011;51: 1015-1024.
12. Ferrannini E, Cobelli C: The kinetics of insulin in man. I. General aspects. Diabetes Metab Rev 1987;3:335-363.
13. Toffolo G, Campioni, Basu R, et al.: A minimal model of insulin secretion and kinetics to assess hepatic insulin extraction. Am J Physiol Endocrinol Metab 2006;290:E169-E176.
14. Kovatchev BP, Cox DJ, Gonder-Frederick LA, et al.: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 1998;21:1870-1875.
15. Kovatechev PB, Straume M, Cox DJ, Farhy LS: Risk analysis of blood glucose data: a quantitative approach to optimizing the control of insulin dependent diabetes. J Theor Med 2000; 3:1-10.
16. Nathan DM, Kuennen J, Borg R, et al.: Translating the A1C assay into estimated average glucose values. Diabetes Care 2008;31:1473-1478.
17. Moller JB, Kristensen NR, Klim S, et al.: Methods for predicting diabetes phase III efficacy outcome from early data: superior performance obtained using longitudinal approaches. CPT Pharmacometrics Syst Pharmacol 2014;3:e122.