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New Methods May Mean Fewer Insulin Shots for Diabetics

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The spray device has been tested in about 300 patients in the U.S. and other countries. In Canada, long-term trials -- the final step before drug approval -- recently began. The U.S. equivalent of those studies is expected to begin within the next two or three months, Krosnick says.

But a few hurdles must be cleared before the devices are approved for use. One potential problem is that, unlike injections that are precisely measured, inhaled doses may not be exactly the same each time people take them. Another concern is that taking particles deep into the lungs could cause breathing problems in some people, or lead to unhealthy changes in lung cells.

Skyler says some patients have been on the inhaled insulin for at least three years with no apparent lung problems. He adds that animal studies do not support the idea that insulin causes unhealthy cell changes in the lung. In human studies, testing of lung function has shown no changes among insulin inhalers, according to Inhale Therapeutic Systems, one of several companies that are developing inhaled insulin products.

Although an insulin pill might be easiest of all to use, insulin is currently only taken by injection. That's because it is a protein, which can be broken down in the stomach, like food, before it starts to work on blood sugar. Insulin injections get the drug into the bloodstream fast, and are typically taken before eating and before going to bed. The challenge for researchers has been to convert the insulin into a form that can be absorbed in a way that bypasses the stomach's acids.

Christopher Price tells WebMD that, unlike others who have tried to make pills that protect insulin molecules from degradation by stomach acid, his company, Protein Delivery Inc., of Research Triangle Park, N.C., is taking a different approach. By modifying the insulin's structure with substances that protect it from degradation, then encapsulating the resulting gel-like substance, researchers have been able to get insulin to the liver intact.

"This is important, not only because it mimics the pathway that insulin takes in a normal person, but it is the one thing that's missing from any other method of insulin delivery. They all go into the [bloodstream] first, and very little insulin, in a very delayed fashion, actually gets to the liver," Price says.

The pill is being tested at Georgetown Medical Center in Washington. Price says a viable version is not expected before 2005. Like the spray products, it is meant to be used before meals as a supplement to long-acting insulin.

Another promising advance involves an alternative to insulin itself. Investigators at Merck Research Laboratory are working with a compound derived from the leaf of an obscure fungus found in the Congo. In studies in animals, the fungus was found to mimic the effects of insulin.

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