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The impact of smoking on inhaled insulin.

Himmelmann, Anders; Jendle, Johan; Mellén, Anders; Petersen, Astrid H; Dahl, Ulf L and Wollmer, Per LU (2003) In Diabetes Care 26(3). p.677-682
Abstract
OBJECTIVE—This study, one of the first to address issues of pulmonary insulin delivery in smokers, compared pharmacokinetics of inhaled insulin delivered via the AERx insulin Diabetes Management System (iDMS) in nondiabetic cigarette smokers and nonsmokers.



RESEARCH DESIGN AND METHODS—In this randomized two-period crossover efficacy and safety trial in 27 nondiabetic smokers and 16 nonsmokers (18 men/25 women, mean age 28 years, mean BMI 23.0 kg/m2), subjects received single doses of inhaled insulin (33.8 IU) following overnight fasting on consecutive dosing days. On one dosing day, smokers smoked three cigarettes immediately before insulin administration (“acute smoking”); on the other dosing day, smokers had not smoked... (More)
OBJECTIVE—This study, one of the first to address issues of pulmonary insulin delivery in smokers, compared pharmacokinetics of inhaled insulin delivered via the AERx insulin Diabetes Management System (iDMS) in nondiabetic cigarette smokers and nonsmokers.



RESEARCH DESIGN AND METHODS—In this randomized two-period crossover efficacy and safety trial in 27 nondiabetic smokers and 16 nonsmokers (18 men/25 women, mean age 28 years, mean BMI 23.0 kg/m2), subjects received single doses of inhaled insulin (33.8 IU) following overnight fasting on consecutive dosing days. On one dosing day, smokers smoked three cigarettes immediately before insulin administration (“acute smoking”); on the other dosing day, smokers had not smoked since midnight (“nonacute smoking”). After inhalation, 6-h serum insulin and serum glucose profiles were determined.



RESULTS—Pharmacokinetic results for evaluable subjects were derived from serum insulin profiles. The amount of insulin absorbed during the first 6 h after dosing (area under the exogenous serum insulin curve from 0 to 6 h [AUC(0–6 h)]) was significantly greater in smokers (63.2 vs. 40.0 mU · l−1 · h−1, P = 0.0017); peak concentration was both higher and earlier in the smokers (maximal serum concentration of insulin [Cmax] 42.0 vs. 13.9 mU/l, P < 0.0001; time to maximal serum concentration of insulin [tmax] 31.5 vs. 53.9 min, P = 0.0003). The estimated intrasubject variability of AUC(0–6 h) was 13.7 and 16.5% for nonsmokers and smokers, respectively. No safety issues arose.



CONCLUSIONS—Absorption of inhaled insulin via the AERx iDMS was significantly greater in smokers, with a higher AUC(0–6 h) and Cmax and a shorter tmax. Intrasubject variability of AUC(0–6 h) was low and similar in nonsmokers and smokers. These data prompt more extensive investigation of inhaled insulin in diabetic smokers. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Diabetes Care
volume
26
issue
3
pages
677 - 682
publisher
American Diabetes Association
external identifiers
  • wos:000185505100021
  • pmid:12610021
  • scopus:0038248882
ISSN
1935-5548
DOI
10.2337/diacare.26.3.677
language
English
LU publication?
yes
id
6594a3fe-fb3d-41b7-8949-6242f102bc46 (old id 113066)
alternative location
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12610021&dopt=Abstract
date added to LUP
2007-07-04 17:16:38
date last changed
2017-10-29 04:35:28
@article{6594a3fe-fb3d-41b7-8949-6242f102bc46,
  abstract     = {OBJECTIVE—This study, one of the first to address issues of pulmonary insulin delivery in smokers, compared pharmacokinetics of inhaled insulin delivered via the AERx insulin Diabetes Management System (iDMS) in nondiabetic cigarette smokers and nonsmokers.<br/><br>
<br/><br>
RESEARCH DESIGN AND METHODS—In this randomized two-period crossover efficacy and safety trial in 27 nondiabetic smokers and 16 nonsmokers (18 men/25 women, mean age 28 years, mean BMI 23.0 kg/m2), subjects received single doses of inhaled insulin (33.8 IU) following overnight fasting on consecutive dosing days. On one dosing day, smokers smoked three cigarettes immediately before insulin administration (“acute smoking”); on the other dosing day, smokers had not smoked since midnight (“nonacute smoking”). After inhalation, 6-h serum insulin and serum glucose profiles were determined.<br/><br>
<br/><br>
RESULTS—Pharmacokinetic results for evaluable subjects were derived from serum insulin profiles. The amount of insulin absorbed during the first 6 h after dosing (area under the exogenous serum insulin curve from 0 to 6 h [AUC(0–6 h)]) was significantly greater in smokers (63.2 vs. 40.0 mU · l−1 · h−1, P = 0.0017); peak concentration was both higher and earlier in the smokers (maximal serum concentration of insulin [Cmax] 42.0 vs. 13.9 mU/l, P &lt; 0.0001; time to maximal serum concentration of insulin [tmax] 31.5 vs. 53.9 min, P = 0.0003). The estimated intrasubject variability of AUC(0–6 h) was 13.7 and 16.5% for nonsmokers and smokers, respectively. No safety issues arose.<br/><br>
<br/><br>
CONCLUSIONS—Absorption of inhaled insulin via the AERx iDMS was significantly greater in smokers, with a higher AUC(0–6 h) and Cmax and a shorter tmax. Intrasubject variability of AUC(0–6 h) was low and similar in nonsmokers and smokers. These data prompt more extensive investigation of inhaled insulin in diabetic smokers.},
  author       = {Himmelmann, Anders and Jendle, Johan and Mellén, Anders and Petersen, Astrid H and Dahl, Ulf L and Wollmer, Per},
  issn         = {1935-5548},
  language     = {eng},
  number       = {3},
  pages        = {677--682},
  publisher    = {American Diabetes Association},
  series       = {Diabetes Care},
  title        = {The impact of smoking on inhaled insulin.},
  url          = {http://dx.doi.org/10.2337/diacare.26.3.677},
  volume       = {26},
  year         = {2003},
}