Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced study results comparing treatment of exenatide injection
with insulin glargine on beta-cell function, glycemic control and weight in
people with type 2 diabetes. Study findings showed one year of exenatide
therapy, as compared to insulin glargine, markedly improved different
indices of beta-cell function, along with similar glycemic improvement. In
addition, patients treated with exenatide lost weight, whereas patients
treated with glargine gained weight. These findings were presented at the
43rd Annual Meeting of the European Association for the Study of Diabetes
(EASD) in Amsterdam, The Netherlands(1).
In this randomized study, 69 people with type 2 diabetes who were
treated with exenatide (5 mcg BID for 4 weeks and 10 mcg BID to 20 mcg TID
(20 mcg TID is a currently unapproved dosage of the marketed formulation of
exenatide, BYETTA(R) (exenatide) injection) for the remainder of the year)
or insulin glargine (both with metformin) were compared on measures of
beta-cell function, blood sugar control and weight change after one year
(52-weeks) of treatment.
In this study, people with type 2 diabetes who used exenatide for one
year, compared to those treated with insulin glargine, showed significant
improvements in beta-cell function as measured by arginine and glucose
induced C-peptide (a peptide associated with insulin production) secretion
during a glucose clamp procedure (a technique used to assess insulin
secretion)(2,3). Specifically, C-peptide secretion in response to arginine
administration (which produces maximal beta-cell stimulation) was 146
percent greater after one year of treatment with exenatide when compared to
insulin glargine (mean ratio relative to baseline for exenatide and insulin
glargine + or -SEM: 3.19 + or - 0.24 vs. 1.31 + or - 0.07, respectively,
p
"Previous exenatide studies have shown comparable glycemic improvements
when compared to insulin glargine, as well as improved beta-cell function
that has only been associated with exenatide treatment," said Michaela
Diamant, M.D., Ph.D., Associate Professor of Endocrinology, Department of
Endocrinology, VU University Medical Center, Amsterdam, The Netherlands,
and an author of the study. "This study lends further support to past
findings and showed that adding exenatide significantly improved beta-cell
function as measured by both glucose and arginine induced insulin
secretion."
The side effects associated with exenatide treatment were consistent
with those seen in previous studies. In clinical trials, the most common
side effect is nausea, most of which is mild to moderate, affecting
approximately half of patients and usually decreasing over time.
Exenatide-treated patients had a lower incidence of hypoglycemia compared
to insulin glargine-treated patients (8.3 percent vs. 24.2 percent,
respectively).
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 U.S. Food and Drug Administration ("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. For full prescribing information,
visit BYETTA.
About Incretin Mimetics
Incretin mimetics are a distinct class of agents used to treat
diabetes. An incretin mimetic works to mimic the anti-diabetic or
glucose-lowering actions of naturally occurring human hormones called
incretins. These actions include stimulating the body's ability to produce
insulin in response to elevated levels of blood sugar, inhibiting the
release of a hormone called glucagon following meals, slowing the rate at
which nutrients are absorbed into the bloodstream and reducing food intake.
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 BYETTA.
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 1,700 employees nationwide.
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.
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.
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 exenatide and the revenues generated from exenatide
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 exenatide 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 United States Securities Exchange Commission 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. Bunck MC, Diamant MA, Corner EB, Malloy JL, Shaginian RM, Deng W,
Kendall DM, Taskinen MR, Smith U, Yki-Jarvinen H, and Heine RJ. One
year treatment with exenatide improves beta-cell function and glycaemic
control in metformin treated type 2 diabetes patients. Control/Tracking
Number: A-07-175-EASD.
2. "Definition of C-peptide." MedicineNet. Available at
medterms/script/main/art.asp?articlekey=12467. Accessed
July 25, 2007.
3. Mitrakou A, Vuorinen-Markkola H, Raptis G, Toft I, Mokan M, Strumph P,
Pimenta W, Veneman T, Jenssen T and Bolli G. "Simultaneous assessment
of insulin secretion and insulin sensitivity using a hyperglycemia
clamp." J Clin Endocrinol Metab 1992: 75(2), 379-382.
4. The International Diabetes Federation Diabetes Atlas. Available at:
idf/home/index.cfm?unode=3B96906B-C026-2FD3- . Accessed June 14, 2007.
5. All About Diabetes." American Diabetes Association. Available at:
diabetes/about-diabetes.jsp. Accessed June 14, 2007
6. Direct and Indirect Costs of Diabetes in the United States." American
Diabetes Association. Available at: diabetes/diabetes
statistics/cost-of-diabetes-in-us.jsp. Accessed June 14, 2007.
7. 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.
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