Mersey Clinical Research Seeks Patients with Type 1 Diabetes for Study of Investigational Drug to Improve Metabolic Control
BALTIMORE, June 1 -- Mersey Clinical Research, Inc. today announced that it is seeking people with type 1 diabetes for a clinical study of pramlintide, an experimental drug currently undergoing late-stage clinical testing. These clinical trials are designed to evaluate further the ability of pramlintide to help patients improve their glucose control and thereby lessen the risks of developing serious complications.
"Mersey Clinical Research is participating in an international effort to substantiate the effectiveness of pramlintide," said Dr. James Mersey, Principal Investigator. "Earlier patient studies have demonstrated that pramlintide improved metabolic control without increasing the risk for hypoglycemia, dangerously low blood-glucose concentrations. In preliminary one-year studies, patients who received pramlintide improved their glucose control and their cholesterol profiles. In addition, obese individuals lost weight while on pramlintide. If these further studies which we are conducting support regulatory approval, pramlintide should become the first new drug for improving metabolic control in type 1 diabetes since the discovery of insulin more than 75 years ago," Dr. Mersey added. "In the coming weeks we are looking to enroll additional patients to help us complete this important medical study. All costs of the study will be paid by Mersey Clinical Research."
Pramlintide is a patented analog of the natural hormone amylin, which along with insulin is missing in people with type 1 diabetes. The same cells in the pancreas that produce insulin after meals also secrete a second partner hormone -- amylin. Until the discovery of amylin was reported by researchers at the University of Oxford in 1987, it was believed that people with diabetes only lacked insulin. While replacing insulin has been life saving for the one-million people with type 1 diabetes in the U.S., many of these patients have difficulty controlling their blood glucose within narrow limits. A major National Institutes of Health sponsored study found that chronically elevated blood-glucose concentrations increase the risk of blindness, kidney failure and amputations. Some 2,000 diabetes patients throughout North America and Europe are helping physicians evaluate whether replacing amylin with pramlintide can improve glucose control and thereby lower the risk of complications.
Mersey Clinical Research is seeking persons at least 16 years of age with type 1 (insulin dependent, juvenile-onset) diabetes. Patients must have been taking insulin for at least 12 months, are generally in good health, have a stable insulin regimen for the past two months, and are willing to take additional injections of the experimental drug as an adjunct to insulin therapy.
Diabetes is estimated to cost the American economy approximately $100 billion each year. Diabetes accounts for 15% -- one of every seven U.S. healthcare dollars. Approximately 5% of all Americans suffer from some form of diabetes. The disease occurs when the pancreas no longer produces enough insulin and amylin to regulate the metabolism of blood glucose appropriately. Type 1 diabetes, which first occurs in younger patients, afflicts approximately 10% of all people with diabetes.
"Numerous studies have found that intensive insulin therapy in type 1 diabetes is difficult to maintain successfully. Easy to use drugs that can safely improve on glucose control, and which can lessen treatment costs, are sorely needed," said Dr. Mersey.
Patients with type 1 diabetes interested in learning whether they are eligible to participate in the trial can call 410-583-2471.
Mersey Clinical Research, Inc.
6565 North Charles Street, Suite 411
Towson, MD 21204
Pramlintide is being developed by Amylin Pharmaceuticals, Inc., a San Diego- based company that is focused on developing novel medicines for treating metabolic disorders.
Posted 7 June 1998
Last Updated: Thursday August 29, 2002 20:59:48
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