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, 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.
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 Doctors say, "What's happening is you're making excess glucagon following a meal." The hormone amylin works to control the output of that glucagons. Thus taking insulin without replacing the hormone amylin is like driving a car with only the accelerator and no brakes. They say, "What they are doing is, by taking [amylin] before a meal, they are 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.
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.