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Safety and efficacy of inhaled insulin (AERx((R)) iDMS(1)) compared with subcutaneous insulin therapy in patients with Type 1 diabetes: 1-year data from a randomized, parallel group trial

Moses, R. G.; Bartley, P.; Lunt, H.; O'Brien, R. C.; Donnelly, T.; Gall, M. -A.; Vesterager, A.; Wollmer, Per LU and Roberts, A. (2009) In Diabetic Medicine 26(3). p.260-267
Abstract
Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx((R)) insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes. Patients were randomized 2 : 1 to prandial inhaled (n = 205) or subcutaneous (s.c.) (n = 99) insulin, plus one/two daily injections of neutral protamine Hagedorn (NPH) insulin for 12 months. The primary endpoints were pulmonary function tests (PFT) and baseline changes in chest X-rays at 12 months. Safety and efficacy assessments were measured at regular intervals. PFTs after 12 months were comparable between the groups, except for reduced per cent of predicted carbon monoxide lung diffusing capacity with inhaled insulin (difference: -2.03%, P =... (More)
Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx((R)) insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes. Patients were randomized 2 : 1 to prandial inhaled (n = 205) or subcutaneous (s.c.) (n = 99) insulin, plus one/two daily injections of neutral protamine Hagedorn (NPH) insulin for 12 months. The primary endpoints were pulmonary function tests (PFT) and baseline changes in chest X-rays at 12 months. Safety and efficacy assessments were measured at regular intervals. PFTs after 12 months were comparable between the groups, except for reduced per cent of predicted carbon monoxide lung diffusing capacity with inhaled insulin (difference: -2.03%, P = 0.04) occurring after the first 3 months and then stabilizing. There were no apparent treatment differences in chest X-rays. Overall risk of hypoglycaemia [risk ratio (RR) 1.02, P = 0.83] and adverse events were comparable between groups. Risk of nocturnal hypoglycaemia was higher in the inhaled group (RR 1.58, P = 0.001). Cough [10% (inhaled); 3% (s.c.)] tended to be mild in nature. Inhaled insulin was non-inferior to s.c. insulin for change in glycated haemoglobin (HbA(1c)) after 12 months [difference 0.18% (CI 95% -0.04; 0.39)]. At trial end, mean laboratory measured fasting plasma glucose was lower in the inhaled group (inhaled 9.2 mmol/l; s.c. 11.7 mmol/l; difference: -2.53 mmol/l, P < 0.001). The safety and efficacy results in this trial were similar to those reported with other inhaled insulins; however, inhaled insulin using AERx((R)) iDMS requires further optimization to reduce nocturnal hypoglycaemia before it has comparable safety and efficacy to s.c. insulin aspart. Diabet. Med. 26, 260-267 (2009). (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
inhaled insulin, bolus, aspart insulin, basal, Type 1 diabetes
in
Diabetic Medicine
volume
26
issue
3
pages
260 - 267
publisher
Wiley-Blackwell
external identifiers
  • wos:000264163800010
  • scopus:62449219273
ISSN
1464-5491
DOI
10.1111/j.1464-5491.2008.02654.x
language
English
LU publication?
yes
id
7558afcf-6e4b-4673-877e-5973c991f8f0 (old id 1404956)
date added to LUP
2009-06-15 09:58:28
date last changed
2017-01-01 06:33:03
@article{7558afcf-6e4b-4673-877e-5973c991f8f0,
  abstract     = {Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx((R)) insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes. Patients were randomized 2 : 1 to prandial inhaled (n = 205) or subcutaneous (s.c.) (n = 99) insulin, plus one/two daily injections of neutral protamine Hagedorn (NPH) insulin for 12 months. The primary endpoints were pulmonary function tests (PFT) and baseline changes in chest X-rays at 12 months. Safety and efficacy assessments were measured at regular intervals. PFTs after 12 months were comparable between the groups, except for reduced per cent of predicted carbon monoxide lung diffusing capacity with inhaled insulin (difference: -2.03%, P = 0.04) occurring after the first 3 months and then stabilizing. There were no apparent treatment differences in chest X-rays. Overall risk of hypoglycaemia [risk ratio (RR) 1.02, P = 0.83] and adverse events were comparable between groups. Risk of nocturnal hypoglycaemia was higher in the inhaled group (RR 1.58, P = 0.001). Cough [10% (inhaled); 3% (s.c.)] tended to be mild in nature. Inhaled insulin was non-inferior to s.c. insulin for change in glycated haemoglobin (HbA(1c)) after 12 months [difference 0.18% (CI 95% -0.04; 0.39)]. At trial end, mean laboratory measured fasting plasma glucose was lower in the inhaled group (inhaled 9.2 mmol/l; s.c. 11.7 mmol/l; difference: -2.53 mmol/l, P &lt; 0.001). The safety and efficacy results in this trial were similar to those reported with other inhaled insulins; however, inhaled insulin using AERx((R)) iDMS requires further optimization to reduce nocturnal hypoglycaemia before it has comparable safety and efficacy to s.c. insulin aspart. Diabet. Med. 26, 260-267 (2009).},
  author       = {Moses, R. G. and Bartley, P. and Lunt, H. and O'Brien, R. C. and Donnelly, T. and Gall, M. -A. and Vesterager, A. and Wollmer, Per and Roberts, A.},
  issn         = {1464-5491},
  keyword      = {inhaled insulin,bolus,aspart insulin,basal,Type 1 diabetes},
  language     = {eng},
  number       = {3},
  pages        = {260--267},
  publisher    = {Wiley-Blackwell},
  series       = {Diabetic Medicine},
  title        = {Safety and efficacy of inhaled insulin (AERx((R)) iDMS(1)) compared with subcutaneous insulin therapy in patients with Type 1 diabetes: 1-year data from a randomized, parallel group trial},
  url          = {http://dx.doi.org/10.1111/j.1464-5491.2008.02654.x},
  volume       = {26},
  year         = {2009},
}