Results from a 24-week multi-center, randomized, open-label study presented at ADA 2008 SAN FRANCISCO, June 9
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.
Study Details
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.
About SYMLIN
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.
About Diabetes
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 statements.
(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.
