PHILADELPHIA--(BUSINESS WIRE)--Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced results from new analyses of previously completed clinical studies demonstrating that patients with type 2 or type 1 diabetes achieved a greater proportion of blood glucose measurements in the normal range when SYMLIN® (pramlintide acetate) injection treatment was used along with insulin. Two abstracts highlighting the analyses evaluated the proportion of readings from self-monitored seven-point glucose profiles that fell above, below or within glycemic targets based on guidelines set by the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE). The data analyses are being presented at the 72nd Scientific Sessions of the ADA in Philadelphia.
“These results showed that SYMLIN, when used with mealtime insulin, helped patients maintain their blood sugar in the normal glucose range on a daily basis,” said David Maggs, M.D., vice president, medical research and development, Amylin Pharmaceuticals. “These data provide a ‘real-world’ analysis into the management of daily glucose levels as many patients, whether they have type 1 or type 2 diabetes, struggle to maintain target blood glucose levels despite treatment with mealtime insulin. Recognizing the important role it plays in helping patients control blood sugar at mealtime, ADA/EASD included SYMLIN in their new position statement on the treatment of hyperglycemia.”
In April of this year, the ADA and the European Association for the Study of Diabetes (EASD) published a new Position Statement on the management of hyperglycemia in type 2 diabetes. The Position Statement included key clinical considerations for the use of SYMLIN, reaffirming its use in conjunction with mealtime insulin to decrease post-meal glucose excursions.
Study Design and Findings
In both analyses, researchers
looked at each patient’s self-monitored blood glucose readings before
and after breakfast, lunch and dinner, and determined what proportion of
those readings fell within the normal range according to the targets set
by ADA and AACE. Normal glucose range was defined as 70-130 mg/dL
pre-meal and 70-180 mg/dL post-meal using ADA guidelines, and 70 to less
than 110 mg/dL pre-meal and 70 to less than 140 mg/dL post-meal using
AACE guidelines. Four time periods were analyzed: baseline, week one to
four, week five to 15 and week 16 to study end.
In the clinical data analysis of 138 patients with type 2 diabetes, the proportion of measurements in the normal range for SYMLIN-treated patients increased from 37.2 percent at baseline to 54.6 percent at six months according to ADA guidelines, and from 19.7 percent to 28.4 percent according to AACE guidelines. SYMLIN-treated patients also experienced a decrease in the proportion of measurements in the hyperglycemic range from 61.3 percent to 41.9 percent (ADA) and from 78.8 percent to 68.1 percent (AACE). During all time periods, the proportion of measurements in the hypoglycemic range (less than 70 mg/dL) was low.
Similar statistically significant improvements were also seen in analyses of two studies of patients with type 1 diabetes. In the first analysis of 218 patients from an open-label clinical practice study, the percent of measurements in the normal range increased from 44.3 percent at baseline to 52.5 percent (ADA) at six months and from 27.7 percent to 32.7 percent (AACE). In the second analysis of 248 patients from a 29-week, placebo-controlled study, measurements in the normal range based on ADA criteria increased from 37.3 percent to 43.9 percent for SYMLIN-treated patients (n=115), compared to an increase from 38.2 percent to 40.9 percent in those receiving placebo (n=133). The percent of measurements in the normal range based on AACE criteria increased from 22.6 percent to 27.8 percent for SYMLIN-treated patients compared to an increase from 24.1 to 25.0 in those receiving placebo. The percentage of readings in the hypoglycemic range remained relatively stable.
In these studies, the safety and tolerability of SYMLIN were consistent with its known safety profile, and the most common adverse event was nausea.
About SYMLIN® (pramlintide acetate) Injection
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 analogue 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, beta cells in the pancreas that make both
insulin and amylin are either damaged or destroyed, resulting in reduced
secretion of both insulin and amylin after meals. Amylin deficiency can
make it harder to control glucose levels after meals; therefore, using
SYMLIN can help patients to spend more time in their normal glycemic
range.
The SymlinPen® (pramlintide acetate) pen-injector is an easy way for patients to use SYMLIN and offers convenient pre-filled SYMLIN administration with simple, dial-up dosing to improve mealtime glucose control. The SymlinPen® 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. The SymlinPen® 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.
For additional important safety information about SYMLIN, please see the full Prescribing Information (www.SYMLIN.com/pi) and patient Medication Guide (www.SYMLIN.com/mg).
Important Safety Information for SYMLIN®
(pramlintide acetate) Injection
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.
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 Amylin Pharmaceuticals
Amylin Pharmaceuticals is a
biopharmaceutical company dedicated to improving lives of patients
through the discovery, development and commercialization of innovative
medicines. Amylin is committed to delivering novel therapies that
transform the way diabetes and related metabolic disorders are treated.
Amylin is headquartered in San Diego, Calif., and has a commercial
manufacturing facility in Ohio. More information about Amylin
Pharmaceuticals is available at www.amylin.com.
Forward-Looking Statement
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 that; clinical trials or studies may not start when planned,
confirm previous results, be predictive of real world use or achieve
intended clinical endpoints; preclinical studies and/or the analysis
mentioned in this press release, may not be predictive; our product
candidates may not receive regulatory approval; SYMLIN and the
SymlinPen, and the revenues generated from these products, may be
affected by competition, unexpected new data, technical or safety issues
or manufacturing and supply issues. Commercial and government
reimbursement and pricing decisions and the pace of market acceptance
may also affect the potential for SYMLIN and the SymlinPen. These and
additional risks and uncertainties are described more fully in Amylin's
most recently filed SEC documents, including its Form 10-Q. Amylin
undertakes no duty to update these forward-looking statements.
SYMLIN and SymlinPen are registered trademarks of Amylin Pharmaceuticals, Inc.