Source: San Jose Mercury News (CA)
Contact:  http://www.sjmercury.com/
Pubdate: Wed, 17 Jun 1998
Author: Thomas H. Maugh II - Los Angeles Times

INHALED-INSULIN THERAPY SHOWS PROMISE

1,000 diabetics set for final trials in fall

The first clinical trials using an inhaled form of insulin to treat
diabetics have proven highly successful, paving the way for a greatly
reduced reliance on painful and inconvenient injections of the life-saving
hormone, scientists reported Tuesday.

The key to the study is the development of a finely powdered form of
insulin that is sucked through the mouth into the lungs, where it is
rapidly absorbed into the bloodstream to control blood sugar levels.

Studies in 121 type 1 and type 2 diabetics showed that the inhaled insulin
is at least as effective as injected insulin in controlling the symptoms of
diabetes, has no side effects in the lungs, and is much more popular with
patients, two teams of researchers told a Chicago meeting of the American
Diabetes Association.

``These studies present the first evidence that there are true alternative
ways to administer insulin,'' said Dr. William Cefalu of the University of
Vermont, who led one of the studies.

``This is absolutely a breakthrough in diabetes therapy,'' said Dr. Michael
Bush of Beverly Hills, a past president of the California affiliate of the
American Diabetes Association. ``That's an overused word, but this is truly
a breakthrough.''

Diabetes develops when the pancreas can no longer produce sufficient
quantities of insulin, a hormone that regulates the metabolism and storage
of sugars from food.

About 1 million Americans have type 1 diabetes, which develops in childhood
and always requires insulin for control, and an additional 15 million have
type 2, which develops later in life and can occasionally require insulin
injections.

The new system, being developed by Inhaled Therapeutic Systems of San
Carlos and Pfizer Inc., could prove to be of great benefit to a large
fraction of diabetes patients.

The researchers will begin the final phase of the trials on 1,000 patients
this fall. If that is successful, the product could be on the market within
two years, they said.

Researchers have long sought a better way to deliver insulin. Swallowing a
pill does not work because the insulin is destroyed by acids in the
stomach.

Studies of sniffing insulin through the nose were bogged down by dosing
problems, irritation in the nasal passages and erratic absorption of the
hormone -- especially if the user had a cold.

The new system apparently avoids those problems. The flashlight-size device
allows the user to suck the dry powder through the mouth and directly into
the lungs.

``All the patient has to do is breathe, and most patients know how to do
that,'' said Dr. Jay Skyler of the University of Miami.

The final phase of the trial is expected to begin in November and to last
for six months to one year.

IF YOU'RE INTERESTED People interested in participating in the study may
volunteer by calling Pfizer at (800) 438-1985.

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Checked-by: (Joel W. Johnson)