BYETTA(R) Shown to Reduce Blood Glucose Levels When Added to Patients Using a TZD
June 10 2006 - 1:15PM
PR Newswire (US)
Most patients saw improvements in three critical measures of blood
glucose control WASHINGTON, D.C., June 10 /PRNewswire-FirstCall/ --
Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and
Company (NYSE:LLY) today announced detailed findings from a study
that showed BYETTA(R) (exenatide) injection lowered blood glucose
levels for people with type 2 diabetes who had not achieved target
blood glucose levels despite the use of a thiazolidinedione (TZD)
with or without metformin. Patients using BYETTA showed
improvements in three important measures of blood glucose control:
fasting blood glucose, postprandial blood glucose and hemoglobin
A1C (A1C), which improved by approximately 0.9 percent compared to
the control group. Sixty-two percent of study participants using
BYETTA who completed the full study reached target A1C of 7 percent
or less. Less than 7 percent is the target for good glucose control
as recommended by American Diabetes Association (ADA). BYETTA
treatment also resulted in a reduction in average body weight.
BYETTA-treated patients lost an average of approximately three
pounds of body weight, while those treated with placebo lost on
average approximately one- half pound. These findings were
presented at the 66th Annual Scientific Sessions of the ADA in
Washington, DC. BYETTA (pronounced bye-A-tuh), was approved in
April 2005 as an adjunctive therapy for patients with type 2
diabetes who are not achieving blood sugar control on metformin
and/or a sulfonylurea. "In the context of treating the underlying
defects in people with type 2 diabetes -- beta-cell dysfunction and
insulin resistance -- using combination therapies is a sensible
approach for patients," said Bernard Zinman, MD, Director of the
Leadership Sinai Centre for Diabetes, Mount Sinai Hospital in
Toronto, Ontario and a lead author of the study. "These data
indicate that the addition of BYETTA to TZDs can be a clinically
meaningful treatment for patients." In the first quarter of 2006,
Amylin and Lilly submitted a supplemental New Drug Application to
the Food and Drug Administration seeking approval of BYETTA as an
add-on therapy to treatment with a TZD with or without metformin in
patients with type 2 diabetes. Key Findings A1C reduction: * At the
end of the study, patients on BYETTA experienced an average
reduction in A1C of 0.8 percent from baseline compared to an
increase of 0.1 percent in the control group. * Of patients
completing the full study, 62 percent treated with BYETTA as a
combination therapy achieved an A1C of 7 percent or less, compared
to approximately 16 percent in the control group. Glucose
measurements: * Patients treated with BYETTA had average fasting
glucose, measured before breakfast, that was 27 mg/dL lower than
the control group. * As measured by 7-point glucose monitoring,
BYETTA significantly reduced average 2-hour post-meal glucose
surges following breakfast and dinner by 34 mg/dL from baseline. *
7-point glucose monitoring throughout the day demonstrated a
significant reduction in average glucose concentrations in patients
receiving BYETTA. Weight change: * Patients in the BYETTA arm
showed an average weight reduction of 3.3 pounds compared with an
average weight reduction of 0.4 pounds during treatment in the
control arm. Hypoglycemia: * Rates of mild and moderate
hypoglycemia (low blood sugar) were similar between the BYETTA and
placebo treatments. No severe hypoglycemia was reported. Other
adverse events: * The most common adverse event was mild to
moderate nausea reported by approximately 40 percent of the
patients in the BYETTA group, compared to 15 percent of patients
receiving placebo. Study Design/Protocol 233 patients with elevated
A1C in spite of oral diabetes therapy were involved in the
randomized, placebo-controlled, parallel, double-blind trial for 16
weeks. The trial was designed to determine if BYETTA can be used
safely and effectively as adjunctive therapy to a TZD alone (~ 20
percent) or with a TZD and metformin (~ 80 percent), for people
with type 2 diabetes. Study participants were randomized into
either of two treatments: the first group received a fixed dose of
BYETTA (5 micrograms twice-a-day for first four weeks, then 10
micrograms twice-a-day for remainder of study) in conjunction with
a TZD, with or without metformin, and the second group received
placebo with a TZD, again with or without metformin. The average
A1C at baseline was 7.9 percent. These detailed findings supplement
the primary results released in 2005. About BYETTA BYETTA is the
first incretin mimetic, a class of drugs 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, secreted
in response to food intake, has multiple effects on the intestine,
liver, pancreas and brain that work in concert to regulate blood
sugar.(1) Safety and Tolerability Adverse events associated with
BYETTA are generally mild to moderate in intensity. In clinical
trials, the most frequently reported adverse event was
mild-to-moderate, dose-dependent nausea. With continued therapy,
the frequency and severity of nausea decreased over time in most
patients. Patients receiving BYETTA in combination with a
sulfonylurea may be at a higher risk of hypoglycemia or low blood
sugar. To reduce this risk, decreasing the dose of sulfonylurea may
be considered. When patients begin taking BYETTA, the symptoms,
treatment and conditions that predispose development of
hypoglycemia should be explained to them, and the patient's usual
instructions for hypoglycemia management should be reviewed and
reinforced. Patients should also be advised that treatment with
BYETTA may lead to a reduction in appetite, food intake and/or body
weight, and that there is no need to modify the dosing regimen due
to such effects. BYETTA is not a substitute for insulin in
insulin-requiring patients. BYETTA should not be used in patients
with type 1 diabetes. Use of BYETTA is not recommended in patients
with end-stage renal disease or severe renal impairment, or in
patients with severe gastrointestinal disease. BYETTA should be
used with caution in patients receiving oral medications that
require rapid gastrointestinal absorption. For complete safety
profile and other important prescribing considerations, visit
http://www.byetta.com/. About Incretin Mimetics Incretin mimetics
is a distinct class of treatment in the fight against 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. BYETTA is the first
FDA-approved incretin mimetic. About Diabetes Diabetes affects an
estimated 194 million adults worldwide(2) and more than 20 million
in the United States.(3) Approximately 90 to 95 percent of those
affected have type 2 diabetes, a condition characterized by failure
of the pancreatic beta cells to adequately respond to the increased
demands for insulin that occur as a result of obesity-related
insulin resistance.(4) Diabetes is the sixth leading cause of death
by disease in the United States(3) and costs approximately $132
billion per year in direct and indirect medical expenses. Type 2
diabetes usually occurs in adults over the age of 40, but is
increasingly common in younger people.(3) According to the Centers
for Disease Control and Prevention's National Health and Nutrition
Examination Survey, approximately 60 percent of diabetes patients
do not achieve target hemoglobin A1C levels (less than 7 percent
according to ADA guidelines(5)) with their current treatment
regimen.(6) 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, SYMLIN(R) (pramlintide acetate)
injection and BYETTA(R) (exenatide) injection. Amylin is located in
San Diego, California with over 1200 employees nationwide. Further
information on Amylin Pharmaceuticals, its marketed products, 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, IN, 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/. 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/. 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 factors, including that BYETTA may
be affected by unexpected new data, technical issues, or issues
related to manufacturing and supply; future clinical trials may not
replicate previous trial results; BYETTA may not prove to be an
important therapeutic option; the request to expand the indication
for BYETTA to include its use as an adjunct to TZDs may not receive
regulatory approval; or risks and uncertainties inherent in the
collaboration with, and dependence upon, Lilly or Amylin. The
potential for BYETTA may also be affected by government and
commercial reimbursement and pricing decisions, or the pace of
market acceptance. These and additional risks and uncertainties are
described more fully in Amylin and Lilly's most recent SEC filings,
including our Form 10-Qs. Amylin and Lilly disclaim any obligation
to update these forward-looking statements. P-LLY 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 April 12, 2005. (3) Centers for Disease Control and
Prevention, National Diabetes Fact Sheet. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. (4) Turner RC,
Cull CA, Frighi V, Holman RR. Glycemic control with diet,
sulfonylurea, metformin, or insulin in patients with type 2
diabetes mellitus: progressive requirement for multiple therapies
(UKPDS 49). JAMA. 1999; 281(21):2005-2012. (5) American Diabetes
Association. Standards of medical care in diabetes 2006. Diabetes
Care 2006;29:S4-42. (6) Harris MI, Eastman RC, Cowie CC, Flegal KM,
Eberhardt MS. Racial and ethnic differences in glycemic control of
adults with type 2 diabetes. Diabetes Care. 1999;22:403-408. (Logo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO
DATASOURCE: Eli Lilly and Company; Amylin Pharmaceuticals, Inc.
CONTACT: Jamaison Schuler of Lilly, +1-317-655-2111, cell:
+1-317-997-1485; Alice Bahner of Amylin, +1-858-642-7272, cell:
+1-858-232-9072
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