Results from a 24-week multi-center, randomized, open-label study presented
at ADA 2008
SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced data showing that the use of mealtime SYMLIN(R) (pramlintide acetate) injection with basal insulin therapy for 24 weeks resulted in more patients achieving diabetes treatment goals of improved glucose control without weight gain or hypoglycemia compared to the use of rapid-acting insulin (RAI) with basal insulin in patients with type 2 diabetes. The results were detailed in an oral presentation at the American Diabetes Association's (ADA) 68th Annual Scientific Sessions in San Francisco.
"These findings are promising because they suggest that treating a deficiency of the hormone amylin in type 2 diabetes can have a beneficial effect on glucose control even when mealtime insulin is not used," said Matthew Riddle, M.D., Professor of Medicine and Head of the Section of Diabetes, Division of Endocrinology at Oregon Health Sciences University and clinical trial investigator. "The effect of SYMLIN was similar to that of mealtime rapid-acting insulin when either was added to basal insulin treatment in this study, with SYMLIN use resulting in no weight gain and less hypoglycemia."
The study was designed to demonstrate improvement in pre-defined comprehensive diabetes treatment goals that included achieving a target A1C and experiencing no weight gain or episodes of severe hypoglycemia. Among those treated with mealtime SYMLIN, 1 in 3 achieved this composite set of goals while only 1 in 10 patients treated with RAI achieved the same results (30 percent vs. 11 percent; P<0.05). Mild or moderate hypoglycemia incidence was lower in SYMLIN-treated patients (55 percent) compared to RAI-treated patients (82 percent) and no severe hypoglycemia was experienced in either group.
At week 24, similar improvements in glucose control were achieved in the SYMLIN- and RAI-treated groups. SYMLIN-treated patients achieved an A1C reduction of 0.9 percent from baseline compared with a 1.1 percent reduction for RAI. Fasting glucose was also similar between groups. RAI treatment was associated with increased body weight (+9.3 pounds) while SYMLIN treatment was not associated with weight gain (-0.5 pound, P<0.001). The most common side effect associated with SYMLIN in the study was nausea (21 percent vs. 0 percent with RAI), which was primarily mild or moderate nausea and decreased with time.
This 24-week multi-center, randomized, open-label study, called INSTEAD (INitiating Symlin Therapy: Evaluating Alternatives in Diabetes), compared the safety and efficacy of the addition of mealtime SYMLIN or RAI to basal insulin therapy for 24 weeks in 112 patients with type 2 diabetes. Basal insulin dosage was titrated throughout the study seeking a target fasting glucose of 70 to <100 mg/dL. Patients were randomized to receive either mealtime SYMLIN at a fixed dose of 120 micrograms at major meals or RAI titrated to achieve pre-meal blood glucose of >70 to <100 mg/dL. Patients who entered the study taking oral diabetes medicines continued with their usual regimen throughout the study. Average baseline A1C for the study population was 8.2 percent and body weight was approximately 233 pounds.
In a second phase of the study designed to further understand the complementary effects of RAI and SYMLIN, patients not achieving a target A1C of 6.5 percent or less began using both SYMLIN and RAI at mealtime. Results from this phase of the study will be presented in a future scientific forum.
Taken at mealtime, SYMLIN is the first and only amylin mimetic for use in patients with 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.
Pre-filled SymlinPen(R) (pramlintide acetate) pen-injector devices offer convenient SYMLIN administration with simple, fixed dosing to improve mealtime glucose control. SymlinPen(R) 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. SymlinPen(R) 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.
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 for SYMLIN(R)
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 adverse event. 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.
Diabetes affects over 20 million Americans and is growing at three times the rate of population growth.(1) Approximately 4.5 million patients with diabetes use insulin. Diabetes is the fifth leading cause of death by disease in the United States.(1) 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.(2) Poor control of blood sugar may result in severe long-term complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.(1)
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 headquartered in San Diego, California with over 2,000 employees nationwide. Further information on Amylin Pharmaceuticals is available at http://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 due to a number of risks and
uncertainties, including risks that the results of clinical trials may not
be predictive of future results; that SYMLIN and SymlinPen may be affected
by unexpected new data, technical issues, or manufacturing and supply
issues; that new drug applications will not receive regulatory approval;
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 and
SymlinPen. These and additional risks and uncertainties are described more
fully in the Company's most recently filed SEC documents, including its
Form 10-Q. Amylin undertakes no duty to update these forward-looking
(1) "All About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 4, 2008.
(2) Kruger D, Gatcomb P, Owen S. Clinical implications of amylin and
amylin deficiency. Diabetes Educ. 1999;25:389-397.
|SOURCE Amylin Pharmaceuticals, Inc.|
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