Late-Breaking Presentation of Exenatide Pivotal Studies Show Significant Improvements in Glucose Control With Associated Weight
June 05 2004 - 11:00AM
PR Newswire (US)
Late-Breaking Presentation of Exenatide Pivotal Studies Show
Significant Improvements in Glucose Control With Associated Weight
Loss in People With Type 2 Diabetes Data From Pivotal Studies to
Form the Basis of a Mid-2004 FDA Submission ORLANDO, Fla., June 5
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.,
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today presented
detailed 30-week data from two of the three pivotal Phase 3 studies
of exenatide during a late-breaking session at the American
Diabetes Association's (ADA) 64th Scientific Sessions in Orlando,
Florida. 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 studies showed that exenatide
significantly lowered average glucose (blood sugar) levels,
measured by A1C, in patients who were unable to achieve adequate
glucose control on common oral regimens. In addition, exenatide
treatment resulted in reductions in body weight. 52-week data from
open-label extension studies of these pivotal trials were also
released, demonstrating sustained reductions in A1C of one percent
or more with associated weight loss. "The reduction in blood sugar
and the associated weight loss seen with exenatide is an important
combination of effects. With other therapies, improved blood sugar
control is often accompanied by weight gain -- and this weight gain
can be a significant frustration for people working to achieve
better control of their diabetes," said Dr. David Kendall,
International Diabetes Center in Minneapolis, Minnesota. Study
Design/Protocol Approximately 1,000 patients unable to achieve
adequate control with commonly prescribed oral therapies were
involved in the two 30-week, triple- blind, placebo-controlled
pivotal phase 3 studies of exenatide. In both studies, patients
continued their pre-study oral therapies and were randomized to one
of three arms in which they received either 10 micrograms of
exenatide, 5 micrograms of exenatide, or placebo via subcutaneous
injection at breakfast and dinner. At the conclusion of the 30-week
studies, participants in all three treatment arms were offered the
option to continue in open-label extension studies in which all
subjects received 10 micrograms exenatide. Key Study Findings The
first 30-week study examined the effects of exenatide or placebo
when added to the regimens of 336 patients (average disease
duration six years) who were unable to achieve glycemic control
with metformin alone. Of patients completing the study, 46 percent
in the 10 microgram arm achieved an A1C of seven percent or less.
A1C is a measure that reflects a person's average glucose levels
over the prior three to four months. The ADA's recommended target
for A1C is less than seven percent. At the study's outset, the
average A1C of all subjects was 8.2 percent. At the end of the
study, the average A1C for the 10 microgram group was reduced by
0.9 percent (difference from placebo). These reductions in A1C were
accompanied by average reductions in weight of 5.5 pounds or 2.5
kilograms (difference from placebo). In the second 30-week study,
researchers evaluated 733 patients (average disease duration nine
years) who were unable to achieve glycemic control using a
combination of metformin and sulfonylureas. In order to assess the
effect of sulfonylureas on the incidence of hypoglycemia, each of
the three arms of this study were further divided into two groups
taking either maximally effective or minimum recommended doses of
sulfonylurea. At the study's outset, the average A1C of all
subjects was 8.5 percent. Of patients completing the study, 34
percent taking 10 micrograms of exenatide achieved an A1C of seven
percent or less. The average reduction in A1C in the 10 microgram
arm was one percent (difference from placebo). The average
reduction in weight for the 10 microgram group was 1.5 pounds or
0.7 kilograms (difference from placebo). In both studies, exenatide
was generally well tolerated and the most common adverse event
reported was mild to moderate nausea, which occurred most
frequently early in the study. In the 30-week metformin-only study,
45 percent of patients taking 10 micrograms reported nausea,
compared to 23 percent for placebo. The dropout rate due to nausea
was three percent for 10 micrograms and zero percent for placebo.
Hypoglycemia rates were consistent with exenatide's glucose-
dependent action, with no difference between the placebo and drug
arms (five percent for each group). In the metformin-sulfonylurea
combination study, 49 percent of patients taking 10 micrograms
reported nausea compared to 21 percent for placebo. The dropout
rate due to nausea was four percent for 10 micrograms and less than
one percent for placebo. As expected, some patients taking
exenatide in combination with sulfonylurea and metformin
experienced mild-to-moderate hypoglycemia, with those taking the
minimally effective doses of sulfonylureas reporting a lower
incidence than those taking maximally effective doses. The
incidence of mild-to-moderate hypoglycemia was 28 percent in the 10
microgram group and 13 percent in the placebo group. One incident
of severe hypoglycemia was reported in the 5 microgram arm of this
study. No participants withdrew from the study because of
hypoglycemia. One-Year Data Shows Sustained Effect To evaluate the
durability of exenatide's effect at the highest dose tested, the
group of patients who had received 10 micrograms of exenatide for
52 weeks were examined. In the 51 patients who completed 52 weeks
on 10 micrograms of exenatide in combination with metformin, the
average reduction in A1C from baseline was 1.1 percent with average
reductions in body weight of 9.9 pounds (4.5 kilograms). In the 77
patients who had completed 52 weeks on 10 micrograms of exenatide
and a metformin-sulfonylurea combination, the average reduction in
A1C from baseline was 1.0 percent with average reductions in body
weight of 7.3 pounds (3.3 kilograms). About Exenatide Exenatide is
the first in a new class of drugs under investigation 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 diseases 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.
(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.amylin.com/
http://www.lilly.com/
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