Background: This study assessed time action profile and within- and between-subject variability of inhaled Technosphere Insulin (TI) compared with subcutaneous regular human insulin (sc RHI).
Methods: Thirteen subjects with type 2 diabetes (age 56 +/- 7 years, body mass index 30.4 +/- 3.0 kg.m(-2); hemoglobin A1c 6.9 +/- 0.9%; mean +/- SD) participated in this six-period crossover isoglycemic glucose clamp study. In randomized order, each subject received three single doses of TI and sc RHI on separate study days.
Results: Inhalation of TI resulted in a higher maximum serum insulin concentration (858 vs 438 pmol.liter(-1); p = 0.0001) and shorter intervals to maximum insulin concentration (17 vs 135 minutes; p = 0.0001) than sc RHI. Overall, 48 units of TI and 24 units of sc RHI provided comparable 3-hour insulin exposure (INS area under the curve(0-3 h) 55.8 vs 60.0 nmol.min.liter(-1), respectively). Time to maximum metabolic effect was shorter (79 vs 293 minutes; p < 0.0001), and percentage of glucose disposal during the first 3 hours was higher for TI compared with sc RHI (59 vs 27%). Within-subject variabilities of insulin exposure following inhalation of TI for 2 and 3 hours and end of study period were 19, 18, and 16% as compared with 27, 25, and 15% after sc RHI injection (p = not significant).
Conclusion: Technosphere Insulin has a more rapid onset of action than sc RHI. About 60% of the glucose-lowering effect of TI occurs during the first 3 hours after application. In contrast, <30% of the glucose-lowering effect of sc RHI occurs in this period. Technosphere Insulin demonstrated a lower intrasubject variability during the 3-hour postprandial period, without reaching statistical significance.
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| http://dx.doi.org/10.1177/193229680800200206 | DOI Listing |
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Department of Information Engineering, Università Politecnica Delle Marche, Via Brecce Bianche 12, Ancona, Italy.
The aim of this study was to develop a dynamic model-based approach to separately quantify the exogenous and endogenous contributions to total plasma insulin concentration and to apply it to assess the effects of inhaled-insulin administration on endogenous insulin secretion during a meal test. A three-step dynamic in-silico modeling approach was developed to estimate the two insulin contributions of total plasma insulin in a group of 21 healthy subjects who underwent two equivalent standardized meal tests on separate days, one of which preceded by inhalation of a Technosphere Insulin dose (22U or 20U). In the 30-120 min test interval, the calculated endogenous insulin component showed a divergence in the time course between the test with and without inhaled insulin.
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