SAN DIEGO, Sept. 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) today announced positive results from a 16-week study evaluating the safety and efficacy of adding SYMLIN® (pramlintide acetate) to an established regimen of basal insulin glargine (with or without oral antidiabetic agents) in patients with type 2 diabetes who have not progressed to mealtime insulin therapy. At study end, patients receiving SYMLIN on average had better overall glucose control (A1C), reduced glucose fluctuations, used less insulin, and experienced weight loss, compared to those using basal insulin glargine without SYMLIN. Results from this study will form the basis of a supplemental New Drug Application submission to the Food and Drug Administration, currently planned for late 2006.
“This study showed that the addition of SYMLIN provided benefits in addition to A1C improvement for patients failing to meet glucose targets using individualized regimens of basal insulin,” said Orville Kolterman, MD, Senior Vice President of Clinical and Regulatory Affairs. “Achieving improved glucose control without weight gain represents an unmet need in the management of patients with diabetes requiring insulin therapy.”
The study was designed to demonstrate improvement in pre-defined diabetes treatment goals including achieving a target A1C improvement, limiting post- meal glucose increases, and experiencing no weight gain or episodes of severe hypoglycemia. One in four SYMLIN patients achieved the composite set of goals while less than one in ten patients on basal insulin without SYMLIN achieved the target results. Overall rates of hypoglycemia were similar between groups and SYMLIN patients reported mild nausea, consistent with previous study observations.
Study Details
In this randomized, double-blind study, 211 patients with type 2 diabetes who were not achieving target glucose control using an established basal insulin glargine regimen received either placebo or SYMLIN with major meals in addition to their insulin glargine for 16 weeks. The basal insulin glargine doses were adjusted at regular intervals based on an established algorithm to target predefined fasting glucose levels. SYMLIN dose began at 60 micrograms and increased to 120 micrograms as instructed. Patients using common oral diabetes medicines including a sulfonylurea, metformin, or a thiazolidinedione continued with their usual regimen throughout the study. Baseline A1C for the study population was 8.5%, and average body weight was approximately 225 pounds.
Full study results will be submitted for presentation in a future scientific forum.
About SYMLIN
SYMLIN is an antihyperglycemic drug for use in patients with type 1 or type 2 diabetes treated with mealtime 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 and has been shown to reduce body weight.
Healthcare professionals and people with diabetes may obtain more information including the complete prescribing information at 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 is 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® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin’s research and development activities leverage the company’s expertise in metabolism to develop potential therapies to treat diabetes, obesity and cardiovascular disease. Amylin is located in San Diego, California with over 1200 employees nationwide. Further information on Amylin Pharmaceuticals is available at www.amylin.com.
This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The Company’s actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including risks that the FDA may not approve the Company’s sNDA; risks that SYMLIN may be affected by unexpected new data, technical issues, or manufacturing and supply issues; risks that the results of clinical trials may not be predictive of future results; and risks inherent in the drug development and commercialization process. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for SYMLIN. These and additional risks and uncertainties are described more fully in the Company’s recently filed Form 10-Q. Amylin disclaims any obligation to update these forward-looking statements.
Source: Amylin Pharmaceuticals, Inc.
