BYETTA(R) Study Showed Comparable Blood Glucose Control to Insulin
June 24 2007 - 5:45PM
PR Newswire (US)
- BYETTA offers the added benefits of progressive weight loss and
lower risk of hypoglycemia - CHICAGO, June 24
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today announced
study results comparing treatment with BYETTA(R) (exenatide)
injection with insulin glargine in people with type 2 diabetes.
Study findings showed comparable improvements in blood sugar
control with BYETTA and insulin glargine therapies, with weight
loss and lower incidence of hypoglycemia associated with BYETTA.
Patients in the study were also taking one of two commonly used
oral medications. These findings were presented at the 67th Annual
Scientific Sessions of the American Diabetes Association (ADA) in
Chicago. This open-label crossover study of 114 people with type 2
diabetes compared treatment with BYETTA (5 mcg for 4 weeks and 10
mcg for 12 weeks) and oral medication (metformin or a sulfonylurea)
with treatment with insulin glargine and oral medication on
measures of blood sugar control, weight change and incidence of
hypoglycemia during two 16-week periods. Treatment with BYETTA
resulted in blood sugar control (measured by A1C reductions)
comparable to treatment with insulin glargine (-1.43 percent vs.
-1.41 percent, respectively).(1) However, BYETTA treatment with
metformin resulted in statistically significant lower risk of
hypoglycemia (2.6 percent) than treatment with insulin glargine and
metformin (17.4 percent). Additionally, there were seven episodes
of severe hypoglycemia in three patients taking insulin glargine
and no severe episodes during treatment with BYETTA, reflecting a
lower overall risk of hypoglycemia. BYETTA treatment was also
associated with a 5.7-pound weight loss from baseline, compared
with a 1.3-pound weight gain among individuals in the insulin
glargine group (a 7.0-pound difference between groups). "Adding
BYETTA to oral medication to achieve target blood sugar control
levels can be an important next step in the management of type 2
diabetes," said Michael Trautmann, MD, lead investigator of this
study and Medical Fellow of Eli Lilly and Company. "This study
shows that adding BYETTA to oral medication before insulin use may
help people with type 2 diabetes obtain the same glucose control as
insulin and yet lose weight with reduced risk of hypoglycemia."
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 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/. Safety and Tolerability 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. About Diabetes
Diabetes affects more than 20 million in the United States and an
estimated 246 million adults worldwide.(2,3) 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.(4) 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.(5) 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 REFERENCES 1.
Trautmann ME., Burger J., Johns D., Brodows R., Okerson T., Roberts
A., and Barnett A. Less hypoglycemia with exenatide versus insulin
glargine, despite similar HbA1c improvement, in patients with T2DM
adjunctively treated with metformin. Abstract # 0172-OR. 2. The
International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 14, 2007. 3. "All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 14, 2007.
4. "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. 5. Saydah SH, Fradkin J, Cowie CC. "Poor
Control of Risk Factors for Vascular Disease Among Adults with
Previously Diagnosed Diabetes." JAMA. 2004: 291(3), 335-342. (Logo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO
http://photoarchive.ap.org/ DATASOURCE: Eli Lilly and Company
CONTACT: Media, Kindra Strupp, of Eli Lilly and Company,
+1-317-277- 5170, +1-317-554-9577 cell; or Alice Bahner Izzo, of
Amylin Pharmaceuticals, Inc., +1-858-642-7272, +1-858-232-9072 cell
Web site: http://www.lilly.com/ http://www.byetta.com/
http://www.amylin.com/ http://www.lillydiabetes.com/
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