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Insulin Mouth Spray Works Fast, Study Shows

Insulin Product Sprayed Inside Cheek, Still Awaits Approval

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June 16, 2005 -- An insulin mouth spray works faster and seems to be just as effective as insulin injections, a new study shows.

The insulin mouth spray is a product called Oral-lyn from Generex Biotechnology in Toronto. A small Generex-funded study in Israel indicates that Oral-lyn might make life easier for some people with type 1 and type 2 diabetes that need insulin.

The study shows that the insulin mouth spray works faster than insulin injections, says Gerald Bernstein, MD, Generex vice president for medical affairs. Bernstein is a past president of the American Diabetes Association.

"The beauty of it is, it can be taken just before you eat and just after you eat," Bernstein tells WebMD. "This is a very fast insulin. It is regular insulin, which ordinarily is slow, but when sprayed into the mouth, it gets into the bloodstream very quickly."

Oral Insulin Spray Mimics Normal Insulin

When a healthy person eats a meal, blood sugar levels go above normal. This triggers the release of a hormone -- insulin -- which brings blood sugar levels back down again. This crucial mechanism is missing in people with type 1 diabetes and doesn't work well in people with type 2 diabetes.

Self-administered insulin injections offer control over spiking blood sugar. But it's tricky. The insulin injection has to be taken ahead of mealtime. And because insulin levels don't go down as soon as blood sugar is under control, a person may have to snack to avoid a blood-sugar crash.

And there's another issue. Many people, especially children with type 1 diabetes, dread having to take frequent insulin shots.

What's on the Horizon

That's why Generex -- and many other drug companies -- are working on different ways to deliver insulin. Other companies are developing inhaled insulin products, insulin skin patches, and even forms of insulin that can be swallowed.

The Oral-lyn study, by Simona Cernea, MD, and colleagues at Hadassah Hebrew University Hospital, in Jerusalem, looked at seven healthy volunteers. At different times, the volunteers took various doses of Oral-lyn ranging from five to 20 puffs or a placebo spray. They also received one injection of regular insulin.

The bottom line: Oral-lyn started working faster -- and quit working sooner -- than injections of regular insulin. The more puffs of insulin people sprayed into their mouths, the more insulin they had in their blood. The findings appear in the June issue of Diabetes Care.

That's good news, says Robert Rizza, MD, the newly installed president of the American Diabetes Association. Rizza is professor of medicine in the division of endocrinology, diabetes, nutrition, and metabolism at the Mayo Clinic College of Medicine in Rochester, Minn.

"In order to control blood sugar, you have to have a match between how quickly blood sugar goes up after you eat and how quickly insulin goes up," Rizza tells WebMD. "This paper shows a pretty good match. This gives yet another, perhaps a more convenient way to get that needed profile."

Is This Trip Really Necessary?

Insulin is one of the great breakthroughs for modern medicine. It's already saving untold numbers of lives. But are these new forms of insulin really something that will help patients?

Yes, says Rizza.

"Anything that makes insulin simpler and easier to take is a major step forward," he says. "Many people's blood sugars are higher than need be. But they wait too long to start taking insulin and subject their bodies to harm. So anything that allows you to control your blood sugar sooner is likely to be a benefit."

While the Oral-lyn product looks promising, Rizza notes that many other products are working their way through the clinical trial process.

"A lot of imaginative ways have been come up with to get insulin into the body," he says. "If they work out, it will be up to the individual person to decide what form is most convenient."

Bernstein says that Oral-lyn will soon be licensed in Ecuador, where diabetes researcher Jaime Guevara-Aguirre, MD, has been conducting clinical studies. Within the year, Bernstein expects definitive clinical trials to begin in Canada and in Europe. Still larger trials -- yet to be planned or even funded -- would be needed for U.S. approval.

WebMD Health News

Sources

SOURCES: Cernea, S. Diabetes Care, June 2005; vol 28: pp 1353-1357. Gerald Bernstein, MD, vice president for medical affairs, Generex Biotechnology, Toronto. Robert Rizza, MD, president, American Diabetes Association; professor of medicine, division of endocrinology, diabetes, nutrition, and metabolism, Mayo Clinic College of Medicine, Rochester, Minn.

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