New Advances in Insulin Therapy on the Horizon
 Of the more than 17 million Americans with diabetes, about 3.7 million must take one to five insulin shots daily to control their disease. The past several years have brought many advances in research into the way this insulin is administered or may be administered in the future. Currently, three insulin analogs (man-made insulins) are available to imitate the body's natural insulin-release pattern. The long-acting analog, glargine (Lantus), lasts 24 hours, in theory lowering blood-sugar levels throughout the day. The two short-acting analogs (lispro [Humalog] and aspart [Novolog]) take effect quickly and then stop working within four to six hours, so they are active when people need them-during a meal and after. Now, researchers are also closing in on alternatives to the insulin shot. At the American Diabetes Association's 62d Annual Scientific Sessions in June, research was presented revealing major developments in the insulin pill, insulin patch, inhaled insulin and an oral spray. Insulin Pills
Previous efforts to develop an insulin pill have fallen short because insulin molecules were either too large to pass through stomach membranes or the pills degraded too quickly to become effective. But recent studies show two pills have proved successful in increasing insulin absorption into the bloodstream. Both are still under study but are the first to overcome the absorption obstacle. Emisphere Technology has developed a pill that allows insulin to enter the circulatory system, mimicking the physiological production and excretion of insulin. A second pill, developed by Nobex Corp. and GlaxoSmithKline, uses patented polymer technology to resist enzymatic degradation and promote absorption into the bloodstream. Skin Patch
This alternative may well be the first to reach the marketplace, since it uses "off the shelf" insulin, meaning only the delivery system will require government approval before it can be sold to consumers. The insulin skin patch, being developed by Altea Development Corp., involves a two-step process. First, an electronic adhesive patch, powered by a small battery, is applied to the skin. In less than a second, it painlessly vaporizes cells on the skin's surface, creating microscopic openings. Then a small patch, containing a reservoir of insulin, is applied to the skin, much like a Band-Aid. Research shows that wearers successfully absorb insulin through the skin over a 12-hour period. The company is currently working on a 24-hour version. Oral Spray
An oral insulin spray, which allows insulin to be absorbed through the mucous membranes on the cheeks, tongue and throat, has been shown to provide the same benefit as insulin injections. The Rapid Mist device, developed by Generex Biotechnology Corp., looks much like the metered dose inhalers used by people with asthma. The device has been modified to deliver Oralin, a liquid aerosol version of insulin. Inhaled Insulin
Researchers at several pharmaceutical companies are also working to develop systems that deliver insulin in liquid or dry-powder form through the mouth. Instead of being absorbed through the cheeks, however, this rapid-acting insulin is inhaled directly into the lungs, where it is absorbed and enters the bloodstream. Research is now underway to determine whether insulin delivery through the lungs is safe, cost-effective and viable for long-term use. Combination Therapy
To date, there is no new product that can singlehandedly replace the insulin shot. Both the Emisphere pill and the patch deliver only the "basal" or background level of insulin a person needs throughout the day and night. People with diabetes also require a "bolus," or short-acting dose, of insulin at mealtimes. The pill under development by Nobex/GlaxoSmithKline delivers this type of insulin, as do the oral spray and inhaled insulin products. People with diabetes who prefer not to take insulin shots may find themselves using a combination of these new therapies once they are fully developed and approved for sale.  Back Index Page
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