Thursday, September 8, 2005

Exubera Inhaled Insulin

Filed under: Medicine , Pediatrics

The number of people in the United States who have diabetes is believed to have tripled in the last quarter-century. Millions of people with diabetes rely on injections to control their blood sugar.

Inhaled insulin called Exubera, could help diabetics who are reluctant to take injections. The insulin is being developed by Pfizer, Sanofi-Aventis and Nektar Therapeutics.

Chief concerns about the drug involve its long-term effects on the lungs, as well as whether it is safe and effective on people who smoke or have lung disease, according to documents released by the Food and Drug Administration.

During drug trials, researchers found that inhaled insulin was generally as effective as injections in controlling blood sugar levels. However, some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity.

"The prospect of being able to use insulin while avoiding some... or all... of the injections historically part and parcel of insulin therapy stands to appeal to many patients, family members and physicians," wrote Dr. David Orloff, director of the FDA's division of metabolic and endocrine drug products.

"It is essential that we and they understand the benefits and risks of this novel drug-device combination," Orloff said.

Inhaled insulin could be used to manage blood sugar levels for people with either type who need insulin injections before meals. It wouldn't replace longer-acting insulin injections for people with Type 1 diabetes who need to take theirs in the morning or before bed, according to FDA documents.

As we wait for the FDA's decision, you can read more about Exubera inhaled insulin at Nektar Therapeutics...

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replies: 2 comments
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I had two patients who participated in the clinical trial for inhaled insulin.
Neither had adequate control of their diabetes. Of course they were not the most compliant patients.
Not sure if it is administered via a MDI like you have pictured. If it is, then I doubt many patients will be controlled because there are few patients who can use MDIs appropriately.
Color me skeptical.


Posted by: cardioNP
on September 9, 2005 10:11 PM GMT

I was a participant in the test arm of a 30-month Exubera trial; I completed participation 2weeks ago. (I am not a physician.) The delivery device IS NOT a MDI as pictured; it is a much larger device, perhaps 12 inches long when extended for use. I found the device less convenient (I have injected insulin for 35 years), although not unpleasant. Dosing Exubera requires more time than injecting, depending on the dose required. I may have achieved marginally better control during the trial but this is difficult to assess.

Following the Advisory Committee's positive recommendation on Exubera, I see news comment on pulmonary function complications, but none on the other factor noted with Exubera use: creation and/or elevation of insulin antibodies. I understand from my PI that many/most participants develop elevated levels of antibodies after a period of time on inhaled insulin; the direct result is that the dosing requirements become elevated. As my antibodies rose, I required about 3 times as much Exubera as initially to maintain control. Unanswered qestions persist: I was never aware of antibodies with injected insulin, and neither was my ENDO. I am told that testing for them is extremely costly, and never done in clinical practice -- so I am unaware of whether injected insulin commonly produces antibodies, or whether these are specific to the route of delivery. My PI has also indicated that in "most people," the antibody level ultimately turns over and declines; mine has yet to do so. I have been off Exubera for approx 6 months after completing the active phase of the trial, and declined to enroll in a follow-on trial. I assume that, if nothing else, dose elevation as a result of antibody development will have significant cost implications for the use of Exubera -- which I hardly expect to be comparable in cost to injectable insulin to begin with. I would be interested in seeing other information or experiences related to the antibody issue.


Posted by: Ken Patrick
on October 3, 2005 06:19 AM GMT