New Diabetes Drug Next Big Step
By Stacie Overton, Ivanhoe Health Correspondent
(Ivanhoe Newswire) -- A new drug under review by the FDA could be one of the most significant advances in diabetes since the discovery of insulin more than 80 years ago, say doctors involved in the research.
Diabetes is a disease in which the hormone insulin is not made by the body (type 1 diabetes) or the body does not effectively use the insulin it does produce (type 2 diabetes). Researchers from Amylin Pharmaceuticals, Inc., are studying another hormone -- amylin -- to aid in the treatment of diabetes. Amylin is a hormone secreted with insulin by the beta cells in the pancreas. The drug, called SYMLIN, is a man-made version of amylin. Specifically, the drug would be for diabetics -- type 1 or type 2 -- who take insulin injections.
Orville Kolterman, M.D., Senior Vice President of Clinical Affairs at Amylin Pharmaceuticals, Inc., in San Diego, says insulin does not totally suppress the glucagon that the body secretes. Often, diabetics notice that their blood sugar levels tend to be higher after a meal -- even when they take insulin to cover the amount of food eaten. Insulin stimulates the removal of glucose in the blood, but Dr. Kolterman says, "What's happening is you're making excess glucagon following a meal." The hormone amylin works to control the output of that glucagon. Dr. Kolterman tells Ivanhoe taking insulin without also replacing the hormone amylin is like driving a car with only the accelerator and no brakes. He says, "What we're doing is, by taking [amylin] before a meal, we're putting brake fuel back in the brake system."
Studies show, after six months, amylin causes a significant reduction in hbA1c levels. These levels reflect a patient's average blood sugar level over the last three months. The drug currently cannot be mixed with insulin, so patients would need to take additional injections. Dr. Kolterman has not found that to be a problem among most of the patients in the studies.
Dr. Kolterman says the FDA sent an approvable letter for the drug in October 2001 but thought more studies needed to be done. After five additional studies were conducted, the research was submitted again to the FDA in June 2003. The final decision on this drug, which will be marketed as SYMLIN, is expected no later than December 2003. When asked what he expects to happen, Dr. Kolterman says, "I'm optimistic."
This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.
SOURCE: Ivanhoe interview with Orville Kolterman, M.D., Senior Vice President of Clinical Affairs at Amylin Pharmaceuticals, Inc. in San Diego, 2003
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