ADA abstracts came off of embargo this morning. Here's the most important one for ARDM:
>>Evaluation of Lung Function in Patients with Type
2 Diabetes Using the AERx[reg] Insulin Diabetes
Management System (iDMS)
Abstract Number: 463-P
Authors: PER WOLLMER, PER CLAUSON
Institution: Malm[oslash], Sweden; Bagsvaerd, Denmark
Results: Development of systems for inhalation of insulin requires close monitoring of lung function (LF). We report results of pulmonary function tests (PFT) from a multi-centre, randomized, parallel, open-labelled, 12-week study in 107 non-smoking type 2 diabetic patients where pre-prandial s.c. (n=53) and inhaled human insulin via the AERx[reg] iDMS (n=54), both in combination with NPH insulin at bedtime, were compared. The two groups were comparable, with mean age 59 years, BMI 27.7 kg/m[sup2], and HbA1c 8.5% (8.6% vs. 8.5%, AERx vs. s.c.). Both groups showed a similar decline in HbA1c after 12 weeks (7.8% vs. 7.8%, p=0.60).
The aims of PFT were to 1) assess LF in diabetic patients before treatment with inhaled insulin, 2) assess changes in LF after treatment with inhaled insulin, and 3) assess the reproducibility in PFT in this multi-centre study of diabetic patients. At inclusion, forced vital capacity (FVC), total lung capacity (TLC) and forced expiratory volume (FEV1) were all significantly lower (p<0.01 in all cases) than predicted values, mean values ± SD being 96.4±13.2, 95.3±13.1, and 96.9±12.7% predicted, respectively. The FEV1/FVC ratio was significantly higher than predicted (102.9±8.6%) and the diffusing capacity for carbon monoxide (DLCO) was lower than predicted (92.4±16.7% predicted). This indicates restrictive lung function impairment in patients with type 2 diabetes. There were no significant changes in PFT in the groups after 12 weeks. LF does thus not change after 12 weeks of treatment with AERx[reg] iDMS. Two patients in the AERx[reg] group showed a decrease in PFT that were classified as adverse events by the investigators. One patient in the s.c. group had a similar decrease, not considered an adverse event by the investigator. Since LF is expected to be unchanged in patients undergoing s.c. treatment only, the intra-subject variation in PFT can be calculated in this group. Mean coefficients of variation for FVC, TLC, FEV1 and DLCO were 4.2%, 5.0%, 5.0% and 6.7%, respectively. This information about the variability of PFT in diabetic patients should be useful for the design of future trials of inhaled insulin.<<
5% AE rate in AerX group versus none in the s.c. group. Wonder what the actual numbers for those patients are, and what the underlying causes are. Not sure if this group is being subjected to chest X-Rays as in the proof of concept study presented at EASD nine months ago. No direct mention of fibrosis or whether patients were screened for it. And did Punk Ziegel know about these patients or not?
Message 19029431
Here's another:
>>Physicians[rsquo] Reaction to Inhaled Insulin, a
New Insulin Delivery System
Abstract Information
Abstract Number:
456-P
Authors:
DAVID LUERY, DIANE CHAYER
Institution:
Princeton; Bagsvaerd, Denmark
Results:
Inhaled insulin is currently in development. This study was conducted in 2001 to
determine whether or not this would be an interesting option for physicians and
patients.
Personal interviews (1h) obtained reactions to inhaled insulin compared to
subcutaneous and evaluated 2 potential delivery systems (including AERx[reg]iDMS) in
a blind test. The sample included general practitioners (313 GPs) and diabetes
specialists (289 SPs) in Germany, Spain, UK and USA.
Results indicate that patient fear of self-injecting is perceived as one of the most
difficult aspects of initiating insulin: from 20% (UK GPs) to 58% (USA SPs); as well as
concern about compliance: from 19% (UK GPs) to 45% (Germany GPs). Many
physicians believe that inhaled insulin would address both of these aspects. Substantial
proportions of physicians, from 35% (Germany SPs) to 62% (USA GPs), also believe
that inhaled insulin would allow them to initiate insulin earlier.
Two AERx[reg]iDMS features are perceived as advantages over other inhaled insulin
systems: dosing in single unit increments, from 36% (UK) to 62% (US SPs); and
compliance monitoring involving electronic storage of 3 months[apos] data, from 18%
(Spain SPs) to 46% (UK GPs).Inhaled insulin seems to be of benefit for
patients fearing injections and could facilitate insulin initiation. Moreover it is likely to
lead to higher compliance. The features of an electronic system are highly valued.<<
There was a table, but I couldn't get it formatted properly.
Cheers, Tuck |
