CHICAGO, June 23 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. announced today study results showing SYMLIN(R) (pramlintide acetate) injection used in conjunction with basal insulin improved glucose control and reduced weight without increased hypoglycemia in patients with type 2 diabetes inadequately controlled with insulin glargine and oral agents. These findings were detailed in four poster presentations at the American Diabetes Association's 67th Annual Scientific Sessions (ADA) in Chicago.
"We are encouraged by the results from this study investigating the use of SYMLIN with an established regimen of basal, or long-acting, insulin," said Matthew C. Riddle, M.D., Professor of Medicine, Oregon Health & Science University. "Improved glucose control often is accompanied by weight-gain or increased hypoglycemia, but with this approach, neither of these problems occurred while glucose control improved."
This 16-week, randomized, double-blind, placebo-controlled, multicenter study evaluated the safety and efficacy of using SYMLIN as an adjunct to basal insulin glargine in patients with type 2 diabetes. The study demonstrated reductions in a set of pre-defined diabetes treatment goals including A1C, post-meal glucose, weight, and incidence of severe hypoglycemia. One in four SYMLIN patients achieved these goals (a composite endpoint) compared to less than one in ten patients on basal insulin without SYMLIN. A1C is a test that measures average blood sugar levels over approximately three months. Overall rates of hypoglycemia were similar between groups and SYMLIN patients reported mild nausea, consistent with previous studies.
Additional analysis of data from this study demonstrated that weight loss also was associated with a significant reduction in C-reactive protein levels, a marker for increased risk for cardiovascular disease.
Results from this study formed the basis of a supplemental New Drug Application submitted in the fourth quarter of 2006.
About SYMLIN
SYMLIN is an antihyperglycemic drug for use in patients with diabetes treated with insulin. SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of SYMLIN contributes to glucose control after meals.
Healthcare professionals and people with diabetes may obtain more information, including the complete prescribing information and the medication guide, at http://www.symlin.com/.
Important Safety Information
SYMLIN is not intended for all patients with diabetes. SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within three hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high- risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk. This information is highlighted in a boxed warning in the SYMLIN prescribing information for healthcare professionals and in a medication guide for patients, which will be distributed by pharmacists.
Other adverse events commonly observed with SYMLIN when co-administered with insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported. The incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually increased to the recommended doses.
About Diabetes
Diabetes is a large and growing market in the United States, affecting over 20 million Americans and growing at three times the rate of population growth. Approximately 4.5 million patients with diabetes use insulin. Diabetes is the sixth leading cause of death in the United States.
Diabetes is a complex metabolic disease manifesting with a defect in the beta cells in the pancreas, resulting in a deficiency of both insulin and amylin secretion. Poor control of blood sugar may result in severe long-term complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first- in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego, California with over 1,700 employees nationwide. For more information about Amylin visit http://www.amylin.com/.
This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. Amylin's actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including risks that BYETTA or SYMLIN may be affected by unexpected new data, technical issues, or manufacturing and supply issues; risks that the results of pre-clinical studies or clinical trials may not be predictive of future results; risks that our clinical trials will not start or be completed when planned; risks that the FDA may not approve Amylin's regulatory submissions; and risks inherent in the drug development and commercialization process. These and additional risks and uncertainties are described more fully in Amylin's recently filed Form 10-Q. Amylin disclaims any obligation to update these forward-looking statements.
Poster Presentation - Abstract Number: 0536-P
Poster Presentation - Abstract Number: 0538-P
Poster Presentation - Abstract Number: 0541-P
Poster Presentation - Abstract Number: 0552-P
