Amylin Pharmaceuticals Inc. has initiated four additional pivotalclinical trials of its diabetes therapy pramlintide. These U.S. andEuropean Phase III trials complement two other Phase III trials begunin 1995 to test whether pramlintide offers additional blood glucosecontrol to diabetics on insulin and thereby reduces the risk ofcomplications like blindness, kidney failure and nerve damage.
The trials are randomized, double-blind, placebo-controlledexperiments that will involve a total of 2,600 patients at more than200 sites in the U.S., Europe and Canada and will test the product inpatients with both type I diabetes and type II diabetes that requireinsulin. The San Diego, company intends to submit pramlintide forapproval in North America and Europe by the end of 1998 assumingpatient enrollment proceeds as planned.
"Pramlintide could be an important adjunctive therapy for the 7million diabetics that rely on insulin," said Richard Krawiec, directorof corporate communications for Amylin.
Pramlintide is an analog of the hormone amylin which is produced bythe same pancreatic cells that supply the body with insulin. In 1987,researchers discovered that amylin may play an important role inblood glucose regulation. Specifically, amylin appears to control therate at which food enters the intestines and the bloodstream.Diabetics typically lack adequate amounts of the hormone, and as aresult, they have huge amounts of glucose pouring into theirbloodstreams after meals instead of getting a steady release ofglucose.
"Amylin serves to regulate the amount of glucose that makes it intothe bloodstream whereas insulin removes sugar from thebloodstream," said Krawiec. "With both mechanisms disabled,diabetics have very poor control over the amount of glucose in theirbloodstreams. And, glucose is the toxic molecule that causes thecomplications of diabetes."
Scientists at Amylin pharmaceuticals modified the hormone to makeit less sticky and easier to inject. Phase II trials of pramlintide showedthat diabetics using the drug in addition to their insulin regimen hadstatistically significant improvement in glucose control. Amylin andtheir clinical collaborators, Johnson & Johnson, now are testingwhether the drug improves glucose control in the long term. They arealso testing to see if they can reduce the dosing schedule from fourshots per day.
"It's been 75 years since the discovery of insulin and that has been alife saver," Krawiec said. "But, insulin doesn't give adequate glucosecontrol. Pramlintide may offer diabetics on insulin that control." n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.