Influence of acute upper respiratory tract infection on the absorption of inhaled insulin using the AERx insulin Diabetes Management System.
OBJECTIVE
To assess the effects due to an uncomplicated acute upper respiratory tract infection (URTI) on the pharmacokinetics and glucose response of insulin when delivered by oral pulmonary absorption.


METHODS
Normally healthy adult men (n = 11) and women (n = 9) received a single dose of inhaled human insulin, equivalent to approximately 6 IU subcutaneous, using the AERx insulin Diabetes Management System (iDMS), during and following recovery from an URTI. The first dose was administered with ongoing symptoms of < 3 days' duration, the second dose following recovery, and within 3 weeks of the first. Blood sampling for determination of insulin pharmacokinetics (serum AUC(0-6 h), AUC(0-8), C(max),t(max), t(1/2), MRT) and glucose response (plasma AOC(0-6 h)) was performed from 15 min predose to 6 h postdose.


RESULTS
Insulin pharmacokinetics were not different for subjects during and following recovery from URTI [e.g. URTI: no URTI ratio in serum AUC(0-6 h) = 0.92 (95% confidence interval 0.81, 1.05)]; this was reflected by a similar glucose response. Inhaled insulin delivered by AERx iDMS was well tolerated by all subjects; no significant changes were observed in pulmonary function tests. No safety concerns arising from the mode of insulin administration were raised by either dose.


CONCLUSIONS
The results suggest that insulin can be administered via AERx iDMS to nondiabetic subjects experiencing a URTI without any statistically significant changes in insulin pharmacokinetics or pharmacodynamics, and that the necessity for dose adjustments will not differ from subjects with an acute URTI who are receiving subcutaneous insulin.
McElduff
Aidan
A
Department of Endocrinology, University of Sydney at Royal North Shore Hospital, Sydney, NSW 2065, Australia.
Mather
Laurence E
LE
Kam
Peter C
PC
Clauson
Per
P
D000280:Administration, Inhalation; D019540:Area Under Curve; D001786:Blood Glucose / Q000378:metabolism*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D007328:Insulin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D012141:Respiratory Tract Infections / Q000378:metabolism*; D014777:Virus Diseases / Q000378:metabolism*
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin