Volunteers Needed For Inhaled Insulin Study

I will never encourage my son to put insulin in his lungs. This has potential to be extremely dangerous

240 page document prepared by Exubera to the FDA http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf . I have no doubt FDA will approve. Big pharma yields tremendous power in the US.

How small a drop in your airway test would be acceptable to you? Research Probes Efficacy, Safety of Inhaled Insulin -- Simmons 1 (1): 12 -- DOC News ...A "small but clinically insignificant drop" was observed in some of the airways tests, said Anthony Barnett, MD, the lead study investigator for Exubera

Entrez PubMed ....The efficiency of inhaled insulin is lower than that of subcutaneous injection because pulmonary delivery of insulin involves some loss of drug within the inhaler or mouth during inhalation. A concern of many clinicians is the possibility of long-term effects from the intraalveolar deposition of insulin within the lung, since insulin is known to have growth-promoting properties. The long-term safety of these products has not been established.

Entrez PubMed ...In clinical trials of patients with type 1 or 2 diabetes who were treated with Exubera((R)), the only significant clinical adverse effect was cough. This was generally characterized as mild to moderate in severity, decreased over time and was not associated with declines in lung function.

Entrez PubMed ...Completed phase 2 and 3 studies up to 4 years in duration indicate that the differences over time in pulmonary function changes between patients treated with Exubera((R)) and control patients are small, non-progressive, clinically insignificant and reverse after discontinuation of Exubera((R)) therapy

Entrez PubMed ...Among various difficulties of the pulmonary insulin delivery, the finding of an effective promoter, capable of increasing the bioavailability of insulin, is a crucial issue. The cost of such insulin administration might also be a problem. Finally, careful studies concerning the safety of this kind of administration, particularly potential long-term pulmonary toxicity, are mandatory.

Persons with diabetes want to AVOID severe hypoglycemia. This is from an abstract of a recent Skyler article. Entrez PubMed... Inhaled insulin was associated with a lower overall hypoglycemia rate but higher severe hypoglycemia rate. ... Increased insulin antibody serum binding without associated clinical manifestations occurred in the inhaled insulin group. Pulmonary function between the groups was comparable, except for a decline in carbon monoxide-diffusing capacity in the inhaled insulin group without any clinical correlates.

http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_02_00-FDA-TOCTable%20of%20Contents.htm

http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4169S1_00_Slide-Index.htm

INHALER BEWARE