BYETTA(R) Study Showed Sustained Blood Glucose Control Over Three Years in People with Type 2 Diabetes
June 25 2007 - 5:15PM
PR Newswire (US)
- BYETTA offers added benefits of progressive weight loss and
improved beta cell function in an analysis of the longest extension
study to date - CHICAGO, June 25 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and Company
(NYSE:LLY) today announced three- year, open-label study results
that showed treatment with BYETTA(R) (exenatide) injection was
associated with sustained blood sugar control and progressive
weight loss in people with type 2 diabetes. These findings were
presented at the 67th Annual Scientific Sessions of the American
Diabetes Association (ADA) in Chicago. In this open-label extension
study, 217 people with type 2 diabetes not achieving adequate blood
sugar control on oral medication alone (metformin and/or
sulfonylurea) were treated with BYETTA (10 mcg) in addition to
their oral medication(s) for three years. Study participants
treated with BYETTA and oral medication(s) showed sustained
reductions in blood sugar as measured by A1C, a test that measures
average blood sugar levels over approximately three months, and
fasting blood glucose levels (-1.0 +/- 0.1 percent and -23.5 +/-
3.8 mg/dL, respectively).(1) After three years of BYETTA treatment,
46 percent of study participants achieved the American Diabetes
Association's recommended target A1C of 7 percent and 30 percent of
participants achieved an A1C of 6.5 percent.(2) Weight loss from
baseline was progressive, with participants losing on average 11.68
+/- 0.88 lbs at three years. In addition, one in four patients lost
an average of 28.66 lbs. Pancreatic beta cells (beta-cells) are
responsible for producing insulin, a hormone that helps the body
convert glucose (blood sugar) into energy.(3) Type 2 diabetes
develops when the pancreas does not produce enough insulin for the
body to adequately regulate blood sugar levels, or the body is
unable to use the insulin efficiently. In this study, BYETTA
treatment was assessed for improvements in pancreatic beta-cell
function in a subset of 92 study participants. HOMA-B (Homeostasis
Model Assessment), a measure of pancreatic beta-cell function,
improved by 17 percent from baseline over three years. "Type 2
diabetes is associated with impaired insulin production in the
pancreas that progressively deteriorates over time," said John
Buse, Chief of the Division of General Medicine and Clinical
Epidemiology at the University of North Carolina School of Medicine
in Chapel Hill, NC. "Although currently BYETTA is not indicated to
improve beta cell function, these study findings suggest that
long-term BYETTA treatment may help improve insulin production, a
root cause of the condition, and help people with type 2 diabetes
better control their blood sugar levels." BYETTA was generally
well-tolerated in this study, and side effects were consistent with
those seen in previous studies. In clinical trials and post-
approval adverse event reports, the most common side effect is
mild-to- moderate nausea, which affects fewer than half of patients
and usually decreases over time. BYETTA is indicated for use as an
adjunctive therapy for people with type 2 diabetes who are not
achieving blood sugar control using metformin, a sulfonylurea, or a
thiazolidinedione. Over three million prescriptions have been
written in the U.S. since being approved by the Food and Drug
Administration (FDA) in 2005. For more information, visit
http://www.byetta.com/. About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of drugs called incretin mimetics
for the treatment of type 2 diabetes. BYETTA exhibits many of the
same effects as the human incretin hormone glucagon like peptide-1
(GLP-1). GLP-1 improves blood sugar after food intake through
multiple effects that work in concert on the stomach, liver,
pancreas and brain. BYETTA is approved by the FDA for use by people
with type 2 diabetes who are unsuccessful at controlling their
blood sugar levels. BYETTA is an add-on therapy for people
currently using metformin, a sulfonylurea, or a thiazolidinedione.
BYETTA provides sustained A1C control, low incidence of
hypoglycemia when used with metformin or a thiazolidinedione, and
progressive weight loss. For full prescribing information, visit
http://www.byetta.com/. About Diabetes Diabetes affects more than
20 million in the United States and an estimated 246 million adults
worldwide.(4),(5) Approximately 90-95 percent of those affected
have type 2 diabetes. Diabetes is the fifth leading cause of death
by disease in the United States and costs approximately $132
billion per year in direct and indirect medical expenses.(6)
According to the Centers for Disease Control and Prevention's
National Health and Nutrition Examination Survey, approximately 60
percent of people with diabetes do not achieve their target blood
sugar levels with their current treatment regimen.(7) Important
Safety Information for BYETTA(R) (exenatide) injection BYETTA
improves glucose (blood sugar) control in patients with type 2
diabetes who are taking metformin, a sulfonylurea, or a
thiazolidinedione. BYETTA is not a substitute for insulin in
patients whose diabetes requires insulin treatment. BYETTA is not
recommended for use in patients with severe problems with the
stomach or food digestion, or those who have severe kidney disease.
Before using BYETTA, patients should tell their healthcare provider
if they are pregnant, plan to become pregnant, or are
breastfeeding. BYETTA has not been studied in children. When BYETTA
is used with a medicine that contains a sulfonylurea, hypoglycemia
(low blood sugar) is a possible side effect. To reduce this
possibility, the dose of sulfonylurea medicine may need to be
reduced while using BYETTA. Other common side effects with BYETTA
include nausea, vomiting, diarrhea, dizziness, headache, feeling
jittery, and acid stomach. Nausea is most common when first
starting BYETTA, but decreases over time in most patients. BYETTA
may reduce appetite, the amount of food eaten, and body weight.
These are not all the side effects with BYETTA. A healthcare
provider should be consulted about any side effect that is
bothersome or does not go away. For complete safety profile and
other important prescribing considerations, visit
http://www.byetta.com/. About Amylin and Lilly 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.
Amylin's research and development activities leverage the company's
expertise in metabolism to develop potential therapies to treat
diabetes and obesity. Amylin is located in San Diego, California
with over 1,600 employees nationwide. For more information about
Amylin and the company's diabetes products, visit
http://www.amylin.com/. Through a long-standing commitment to
diabetes care, Lilly provides patients with breakthrough treatments
that enable them to live longer, healthier and fuller lives. Since
1923, Lilly has been the industry leader in pioneering therapies to
help health care professionals improve the lives of people with
diabetes, and research continues on innovative medicines to address
the unmet needs of patients. For more information about Lilly's
current diabetes products visit http://www.lillydiabetes.com/.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Indiana,
Lilly provides answers - through medicines and information - for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/. This
press release contains forward-looking statements about Amylin and
Lilly. Actual results could differ materially from those discussed
or implied in this press release due to a number of risks and
uncertainties, including the risk that BYETTA and the revenues
generated from BYETTA may be affected by competition, unexpected
new data, technical issues, clinical trials not confirming previous
results or predicting future results, label expansion requests not
being submitted in a timely manner or receiving regulatory
approval, or manufacturing and supply issues. The potential for
BYETTA may also be affected by government and commercial
reimbursement and pricing decisions, the pace of market acceptance,
or scientific, regulatory and other issues and risks inherent in
the commercialization of pharmaceutical products. These and
additional risks and uncertainties are described more fully in
Amylin and Lilly's most recently filed SEC documents such as their
Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty
to update these forward-looking statements. P-LLY (1) American
Diabetes Association's Diabetes Dictionary. Available at:
http://www.diabetes.org/diabetesdictionary.jsp?pageID=1&exitDictionaryTo=.
Accessed June 8, 2007. (2) American Diabetes Association.
"Standards of Medical Care for Diabetes - 2007. Diabetes Care: 30
(Supplement 1), January 2007. (3) American Diabetes Association's
Diabetes Dictionary. Available at:
http://www.diabetes.org/diabetesdictionary.jsp?pageID=2&exitDictionaryTo=.
Accessed June 8, 2007. (4) The International Diabetes Federation
Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 14, 2007. (5) "All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 14, 2007.
(6) "Direct and Indirect Costs of Diabetes in the United States."
American Diabetes Association. Available at:
http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed June 14, 2007. (7) Saydah SH, Fradkin J and Cowie CC.
"Poor Control of Risk Factors for Vascular Disease Among Adults
with Previously Diagnosed Diabetes." JAMA: 291(3), January 21,
2004. (Logo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO
DATASOURCE: Eli Lilly and Company CONTACT: Media: Kindra Strupp of
Lilly, +1-317-277-5170, cell, +1-317-554-9577; or Alice Bahner Izzo
of Amylin, +1-858-642-7272, cell, +1-858-232-9072
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