Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced I
June 07 2008 - 1:00PM
PR Newswire (US)
Submitted to FDA for Stand-Alone Therapy in Q1 2008 SAN FRANCISCO,
June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today announced
additional results from a study of patients with type 2 diabetes
who were unable to achieve glycemic control through diet and
exercise alone and were treated with either monotherapy
(stand-alone) BYETTA(R) (exenatide) injection taken twice daily or
placebo. Study findings showed that patients treated with
monotherapy exenatide showed statistically significant improvement
in both A1C and weight loss with a lower incidence of nausea than
in previous exenatide studies. Exenatide is indicated as adjunctive
therapy to improve glycemic control in patients with type 2
diabetes mellitus who are taking metformin, a sulfonylurea, a
thiazolidinedione, a combination of metformin and a sulfonylurea,
or a combination of metformin and a thiazolidinedione, but have not
achieved adequate glycemic control. These findings were presented
at the 68th Annual Scientific Sessions of the American Diabetes
Association (ADA) in San Francisco. In this 24-week randomized,
double-blind, placebo-controlled, parallel study of 232 drug-naive
patients (N=77 exenatide 5 mcg, N=78 exenatide 10 mcg, N=77
placebo) with type 2 diabetes who were treated with 5 mcg and 10
mcg of exenatide as a monotherapy reduced their A1C (a measure of
average blood sugar over three months) by 0.7 percentage points and
0.9 percentage points, respectively, from an average baseline A1C
of 7.9 and 7.8 percent, respectively. In the 5 mcg arm, 86 percent
of study participants completed the study and in the 10 mcg arm, 87
percent completed the study. Sixty percent of the 5 mcg evaluable
study participants and 61 percent of the 10 mcg evaluable study
participants achieved or maintained an A1C of less than or equal to
7 percent at study end, a common target for good glucose control.
"Healthcare professionals and their patients with type 2 diabetes
need a variety of treatment options to successfully manage the
disease," said Jim Malone, M.D., Global Medical Director, Eli Lilly
and Company. "These data are robust and show the important glucose
lowering properties of BYETTA taken as monotherapy. If approved,
this indication would give physicians the option to prescribe
exenatide as a stand-alone treatment, which may allow for increased
patient access to BYETTA." This study was conducted following
receipt of an approvable letter for a monotherapy indication from
the FDA in 2005. In addition to the clinical studies included in
the 2005 submission package, data from this study address requests
by the FDA as a result of that approvable letter. Treatment with
exenatide also resulted in a statistically significant lowering of
fasting glucose concentrations for EXE 5 mcg (-17.5+/-4 mg/dL) and
EXE 10 mcg (-18.7+/-4 mg/dL) at endpoint compared with placebo
(-5.2+/-4 mg/dL). A statistically significant weight loss was also
noted of -6.1 pounds (EXE 5 mcg) and -6.8 pounds (EXE 10 mcg)
compared with -3.2 pounds for placebo. In an oral glucose tolerance
test conducted in a subset of patients (N=104), two hour serum
glucose excursion decreased for EXE 5 mcg (-18.4+/-14 mg/dL) and
EXE 10 mcg (-55.1+/-13 mg/dL), while this measure increased
(+4.5+/-14 mg/dL) in patients treated with placebo. In addition,
fasting serum lipid profiles, including total cholesterol and high-
and low-density lipoprotein, remained unchanged and blood pressure
levels improved. Systolic blood pressure decreased from baseline to
endpoint by -3.7+/-1.2 mm Hg in the 5 mcg exenatide group (P=0.037;
vs placebo) and also -3.7+/-1.2 mm Hg in the 10 mcg exenatide group
(P=0.037; vs placebo), compared with -0.3+/-1.2 mm Hg for placebo
(means +/- SEM). Diastolic blood pressure decreased from baseline
to endpoint by -0.8+/-0.7 mm Hg in the 5 mcg exenatide group
(P=0.619; vs placebo) and -2.3+/-0.7 mm Hg in the 10 mcg exenatide
group (P=0.046; vs placebo), compared with -0.3+/-0.7 mm Hg for
placebo (means +/- SEM). There was an incidence of reported nausea
in both the 5 mcg and 10 mcg arms of 3 and 13 percent,
respectively, which is a lower incidence than what was observed in
previous studies, where exenatide has been used in combination with
other diabetes therapies. There were no instances of severe
hypoglycemia. The overall incidence of hypoglycemia was similar to
that seen in studies where exenatide was used in conjunction with
metformin only. Study Population The 24-week, randomized study
included 232 patients with type 2 diabetes who were not achieving
adequate glucose control using diet and exercise without previous
use of antidiabetes agents. Study participants were randomized to
receive subcutaneous injections of placebo, 5 mcg exenatide, or 10
mcg exenatide twice daily without taking any oral antidiabetes
agents. Patients randomized to 10 mcg exenatide received 5 mcg
injections for the first four weeks, and increased to 10 mcg
injections for the final 20 weeks. About BYETTA(R) (exenatide)
injection BYETTA is the first and only FDA-approved incretin
mimetic 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. BYETTA was approved in April 2005 and has
been used by approximately one million patients since its
introduction. For full prescribing information, visit
http://www.byetta.com/. About Diabetes Diabetes affects more than
21 million in the United States and an estimated 246 million adults
worldwide.(1,2) 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.(3) 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.(4) In addition, 85 percent of
type 2 diabetes patients are overweight and 55 percent are
considered obese.(5) Data support that weight loss (even a modest
amount) supports patients in their efforts to achieve and sustain
glycemic control.(6,7) Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2
diabetes. It is used with 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 digesting food
or those who have severe disease of the stomach or kidney. 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 the most common side effect
when first starting BYETTA, but decreases over time in most
patients. If patients experience the following severe and
persistent symptoms (alone or in combination): abdominal pain,
nausea, vomiting, or diarrhea, they should talk to their healthcare
provider because these symptoms could be signs of serious medical
conditions. BYETTA may reduce appetite, the amount of food eaten,
and body weight. No changes in dose are needed for these side
effects. These are not all of the side effects from use of BYETTA.
A healthcare provider should be consulted about any side effect
that is bothersome or does not go away. For full prescribing
information, visit http://www.byetta.com/. 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's research and development activities leverage
the company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in
San Diego, California with over 2,000 employees nationwide. Further
information about Amylin Pharmaceuticals is available at
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 healthcare 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 issue; clinical trials not confirming previous
results; pre-clinical trials not predicting future results; label
expansion requests, including the FDA submission referred to in
this press release, 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 including their
Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
Amylin and Lilly undertake no duty to update these forward-looking
statements. P-LLY (1) The International Diabetes Federation
Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 2, 2008. (2) "All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 6, 2008.
(3) "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 6, 2008. (4) Saydah SH, Fradkin J and Cowie CC. "Poor
Control of Risk Factors for Vascular Disease Among Adults with
Previously Diagnosed Diabetes." JAMA: 291(3), January 21, 2004. (5)
Bays HE, Chapman RH, Grandy S. The relationship of body mass index
to diabetes mellitus, hypertension and dyslipidaemia: comparison of
data from two national surveys. Int J Clin Pract. 2007;61:737-47.
(6) Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association. Diabetes
Care. 2007;30 Suppl 1:S48-65. (7) Anderson JW, Kendall CW, Jenkins
DJ. Importance of weight management in type 2 diabetes: review with
meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9
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DATASOURCE: Eli Lilly and Company CONTACT: Alice Izzo, Amylin,
+1-858-642-7272 (office), +1-858-232-9072 cell; or Kindra Strupp,
Lilly, +1-317-277-5170 (office), +1-317-554-9577 cell
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