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.
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.
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Related links:
http://www.amylin.com
http://www.SYMLIN.com
CONTACT:
Alice Izzo of Amylin Pharmaceuticals, Inc.,
+1-858-642-7272, cell, +1-858-232-9072, alice.izzo@amylin.com; or
Marites Cristobal of Edelman, +1-323-202-1424, cell,
+1-415-819-2214, marites.cristobal@edelman.com, for Amylin
Pharmaceuticals, Inc.
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