Scientific Presentations of Exenatide Data Show Improvements in Glucose Control and Restored Insulin Response in People with Typ
June 06 2004 - 11:00AM
PR Newswire (US)
Scientific Presentations of Exenatide Data Show Improvements in
Glucose Control and Restored Insulin Response in People with Type 2
Diabetes ORLANDO, Fla., June 6 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc., (NASDAQ:AMLN) and Eli Lilly and Company
(NYSE:LLY) plan to present detailed results from two clinical
studies of exenatide during an oral abstract presentation at the
American Diabetes Association's (ADA) 64th Scientific Sessions in
Orlando, Florida on Tuesday, June 8, 2004. Exenatide is the first
potential therapy in a new class of drugs under investigation for
the treatment of type 2 diabetes known as incretin mimetics. The
first presentation will highlight data from one of three Phase 3
pivotal studies for exenatide. Of patients who completed the
30-week study, 41 percent taking 10 micrograms of exenatide
achieved A1C levels of seven percent or less. A1C is a measure that
reflects a person's average glucose (blood sugar) levels over the
prior three to four months. Exenatide treatment also resulted in
reductions in body weight. In addition to 30-week data, results
from an open- label extension study will be presented, showing that
after 52 weeks, exenatide demonstrated sustained effect on both A1C
and body weight. Results from a separate study will be presented
showing that exenatide restored the ability of beta cells to
release insulin immediately following an influx of glucose into the
bloodstream, an action known as first-phase insulin response. A
first-phase insulin response is the normal pattern of insulin
secretion found in healthy individuals, and it is lost early in the
development of type 2 diabetes. "These data suggest that exenatide
may address a fundamental defect of type 2 diabetes by enhancing
the body's ability to produce and release its own insulin in a
manner that mimics that of people without diabetes," said John
Buse, MD, Professor of Medicine and Director, Diabetes Care Center,
University of North Carolina School of Medicine at Chapel Hill.
Pivotal Trial Design/Protocol The pivotal trial was a 30-week,
triple-blind, placebo-controlled study. This study involved 377
diabetes patients unable to achieve glycemic control using
maximally effective doses of sulfonylureas, a commonly used oral
agent. The study was divided into three arms of patients taking
either 10 micrograms of exenatide, 5 micrograms of exenatide, or
placebo via subcutaneous injection twice daily in addition to their
maximally effective doses of sulfonylureas. At the conclusion of
the initial 30-week study, participants in all treatment arms were
offered the opportunity to continue in an open-label extension
study in which they received 10 micrograms of exenatide, twice
daily. Key Pivotal Study Findings At the outset of the study, the
average A1C of patients was 8.6 percent. After 30 weeks, those
taking 10 micrograms of exenatide experienced an average reduction
in A1C of one percent (difference from placebo). These reductions
in A1C were accompanied by average reductions in weight of
approximately 2.2 pounds or 1 kilogram (difference from placebo).
The most common adverse event reported was mild to moderate nausea,
which occurred most frequently early in the study. The dropout rate
due to nausea was four percent for 10 micrograms and zero percent
for placebo. As expected, some patients taking exenatide in
combination with sulfonylurea experienced mild-to-moderate
hypoglycemia. The incidence of mild-to-moderate hypoglycemia was 36
percent in the 10 microgram group and 3 percent in the placebo
group. Sustained reductions in A1C and body weight were observed at
52 weeks in patients who continued in the open-label extension
study. In the 35 patients who completed 52 weeks on 10 micrograms
of exenatide, the average reduction in A1C from baseline was 1.4
percent with average reductions in body weight of approximately 6.4
pounds (2.9 kilograms). "These results demonstrate exenatide's
potential to help patients reduce their A1Cs to a healthy range. In
addition, patients also experienced reductions in body weight and
showed evidence of improved beta cell function," said Dr. Buse.
"That combination could be a very important and unique contribution
to type 2 diabetes treatment." Improvements in Beta Cell Function
In a separate crossover clinical study examining short-term
beta-cell function, beta-cell response to an intravenous glucose
infusion was measured in 25 subjects (12 healthy participants and
13 type 2 diabetes subjects) following treatment with exenatide or
placebo. Researchers assessed beta-cell function by measuring blood
concentrations of glucose, insulin and C-peptide (a marker for
insulin production) at specific intervals following the glucose
infusion. When receiving placebo, type 2 subjects demonstrated a
blunted insulin response following the glucose infusion, a pattern
typical with type 2 patients. Following treatment with exenatide,
when given the same level of intravenous glucose, those same
patients showed a beta-cell response that was equivalent to or
greater than that of healthy subjects of comparable weight. "Type 2
diabetes is caused by the progressive and inevitable failure of the
insulin-producing cells of the pancreas known as the beta cells.
Beta cell failure is progressive despite diet, exercise and
currently available therapies," said Dr. Michael Nauck, Head of the
Diabetes Center, Bad Lauterberg, Germany. "This restoration of
first-phase insulin release by the beta cells is a potentially
important development in the treatment of type 2 diabetes." About
Exenatide Exenatide is the first in a new class of drugs being
investigated for the treatment of type 2 diabetes called incretin
mimetics, and exhibits many of the same effects as the human
incretin hormone GLP-1. GLP-1 has multiple effects on the gut,
liver, pancreas and brain that work in concert to improve blood
sugar (1). About Diabetes Diabetes affects an estimated 194 million
adults worldwide (2) and more than 18 million in the United
States.(3) Approximately 90-95 percent of those affected have type
2 diabetes, in which the body does not produce enough insulin and
the cells in the body do not respond normally to the insulin.
According to the US Center for Disease Control and Prevention's
National Health and Nutrition Examination Survey, approximately 60
percent of diabetes patients do not achieve target A1C levels with
their current treatment regimen. According to the ADA, patients
with A1Cs above target are more likely to develop diabetes-related
complications, such as kidney disease, blindness and heart
disease.(4) About Amylin and Lilly Amylin Pharmaceuticals is
committed to improving the lives of people with diabetes and other
metabolic disorders through the discovery, development and
commercialization of innovative, cost-effective medicines. Further
information on Amylin Pharmaceuticals and its pipeline in
metabolism is available at http://www.amylin.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, which involve risks and uncertainties.
Actual results could differ materially from those discussed or
implied in this press release due to a number of factors, including
the risk that clinical study results may not be replicated or
confirmed, risks that a new drug application for exenatide will not
be filed on a timely basis, risks that exenatide may not receive
regulatory approvals or such approvals may be delayed or limited,
or risks that exenatide may not prove to be commercially
successful. These and additional risks and uncertainties are
described more fully in Lilly and Amylin's most recently filed SEC
documents such as their Annual Reports on Form 10-K, and Amylin's
recently filed Form S-3. REFERENCES 1 Kolterman, O, Buse J, Fineman
M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang
Y, Baron A. Synthetic exendin-4 (exenatide) significantly reduces
postprandial and fasting glucose in subjects with type 2 diabetes.
Journal of Clinical Endocrinology & Metabolism. 2003;
88(7):3082-3089 2 The International Diabetes Federation Diabetes
Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
87B73F80BC22682A. Accessed August 6, 2003. 3 American Diabetes
Association. Available at:
http://www.diabetes.org/main/info/facts/facts_natl.jsp. Accessed
November 20, 2003. 4 Saaddine JB, Engelgau MM, Beckles GL, Gregg
EW, Thompson TJ, Narayan KM. A diabetes report card for the United
States: Quality of care in the 1990s. Ann Intern Med. 2002;
136:565-574. DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly
and Company CONTACT: Eric Shearin of Amylin Pharmaceuticals, Inc.,
+1-858-552-2200; or Morry Smulevitz of Eli Lilly and Company,
+1-317-651-5567 Web site: http://www.lilly.com/
http://www.amylin.com/
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