ORLANDO, Fla., June 26, 2010 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company
(NYSE: LLY) today announced results from a study comparing the
effect of long-term treatment with either BYETTA® (exenatide)
injection or Lantus® (insulin glargine) on overall beta-cell
function. (Beta cells are cells in the pancreas that produce
insulin.) Three years of BYETTA therapy improved indices of
beta-cell function assessed four weeks after discontinuing therapy.
These findings were presented at the 70th Annual Scientific
Sessions of the American Diabetes Association (ADA) in Orlando, Fla.
After three years of treatment, both therapies reduced A1C
similarly (by 0.7 percentage points to 6.6 percent for BYETTA and
by 0.5 percentage points to 6.9 percent for Lantus). A1C is a
measure of average blood sugar over three months. In addition,
BYETTA significantly reduced body weight compared to Lantus
(17-pound difference between groups). After completion of three
years of therapy, a four-week off-drug period followed to allow
assessment of parameters of metabolic state including beta-cell
function. Beta-cell function was assessed using a calculated
disposition index (insulin secretion adjusted for insulin
sensitivity). BYETTA increased insulin sensitivity by 39 percent
and increased the disposition index, indicating an improvement in
background beta-cell function. Lantus had no effect on insulin
sensitivity or disposition index.
"Type 2 diabetes is a progressive disease in which insulin
production typically decreases over time," said Michaela Diamant, M.D., professor of
diabetology, director, Diabetes Center VUMC, Amsterdam, the Netherlands, and principal
investigator of the study. "These findings suggest that with
extended use, BYETTA treatment may help improve insulin production
and help people with type 2 diabetes better control their blood
sugar levels."
Study Design and Findings
In the controlled portion of the study, metformin-treated
patients with type 2 diabetes were randomized to receive BYETTA
(n=36) or Lantus (n=33) and measures of beta-cell function, blood
sugar control and weight change were compared. Baseline
characteristics were age 59+/-8 years; A1C 7.5+/-0.8 percent; BMI
31+/-4 kg/m2; weight 202+/-29 pounds. One-year study results,
previously published in Diabetes Care, found that patients
receiving BYETTA, compared to those treated with Lantus, showed
significant improvements in beta-cell function. However, the
improvements were not sustained following an initial four-week
off-drug period.
In this study, a total of 46 patients entered the two-year
open-label extension period, and 36 completed the study (BYETTA
n=16; Lantus n=20). Insulin sensitivity and beta-cell function were
assessed at baseline and after a second four-week off-drug period,
following a total of three years of treatment. To assess beta-cell
function, an estimate of insulin secretion (first-phase glucose
stimulated C-peptide secretion) was measured. This measurement was
adjusted for insulin sensitivity in the calculated disposition
index. Both therapies reduced A1C similarly (to 6.6+/-0.2 percent
and 6.9+/-0.2 percent for BYETTA and Lantus, respectively) after
three years of treatment. After the four-week off-drug period, the
disposition index was increased in the BYETTA-treated group
compared to baseline (+1.43+/-0.78). The disposition index was
reduced with Lantus (-0.99+/-0.65). In addition, BYETTA increased
insulin sensitivity by 39 percent, while Lantus treatment showed no
effect. Thus, both insulin sensitivity and beta-cell function were
improved after BYETTA therapy for three years.
About Diabetes
Diabetes affects more than 24 million people in the U.S. and an
estimated 285 million adults worldwide. (i,ii) Approximately 90-95
percent of those affected have type 2 diabetes. Diabetes is the
fifth leading cause of death by disease in the U.S. and costs
approximately $174 billion per year
in direct and indirect medical expenses. (iii)
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. (iv) In
addition, 85 percent of type 2 diabetes patients are overweight and
55 percent are considered obese. (v) Data indicate that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control. (vi, vii)
About BYETTA® (exenatide) injection
BYETTA is the first FDA-approved GLP-1 receptor agonist for the
treatment of type 2 diabetes. BYETTA is not indicated to improve
beta-cell function. 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 an injectable prescription medicine that may improve
blood sugar (glucose) control in adults with type 2 diabetes
mellitus, when used with a diet and exercise program. BYETTA is not
insulin and should not be taken instead of insulin. BYETTA is not
recommended to be taken with insulin. BYETTA is not for people with
type 1 diabetes or people with diabetic ketoacidosis.
BYETTA provides sustained A1C control and low incidence of
hypoglycemia when used alone or in combination with metformin or a
thiazolidinedione, with potential weight loss. BYETTA is not a
weight-loss product. BYETTA was approved in April 2005 and has been used by more than one
million patients since its introduction. See important safety
information below. Additional information about BYETTA is available
at www.BYETTA.com.
Important Safety Information for BYETTA® (exenatide)
injection
Based on post-marketing data, BYETTA has been associated with
acute pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. The risk for getting low blood sugar is
higher if BYETTA is taken with another medicine that can cause low
blood sugar, such as a sulfonylurea. BYETTA should not be used in
people who have severe kidney problems, and should be used with
caution in people who have had a kidney transplant. Patients should
talk with their healthcare provider if they have severe problems
with their stomach, such as delayed emptying of the stomach
(gastroparesis) or problems with digesting food. Severe allergic
reactions can happen with BYETTA.
The most common side effects with BYETTA include nausea,
vomiting, diarrhea, dizziness, headache, feeling jittery, and acid
stomach. Nausea most commonly happens when first starting BYETTA,
but may become less over time.
These are not all 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 additional important safety information about
BYETTA, please see the full Prescribing Information
(www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (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. Further
information on Amylin Pharmaceuticals is available at
www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly seeks
to provide patients with breakthrough treatments that enable them
to live longer, healthier and fuller lives. Since 1923, Lilly has
been an 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 www.lillydiabetes.com.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly
provides answers - through medicines and information - for some of
the world's most urgent medical needs. Additional information about
Lilly is available at 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/or the
revenues generated from BYETTA, may be affected by competition;
unexpected new data; safety and technical issues; the study results
mentioned in this press release not being predictive of real-world
results; clinical trials not being completed in a timely manner,
not confirming previous results, not being predictive of real-world
use, or not achieving the intended clinical endpoints; label
expansion requests not 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 development and
commercialization of pharmaceutical products, including those
inherent in the collaboration with and dependence upon Amylin
and/or Lilly. These and additional risks and uncertainties are
described more fully in Amylin's and Lilly's most recent SEC
filings, 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.
BYETTA® is a registered trademark of Amylin
Pharmaceuticals, Inc. All other marks are the marks of their
respective owners.
P-LLY
(i) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed June 19, 2010.
(ii) Diabetes Statistics. American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed June 19, 2010.
(iii) Direct and Indirect Costs of Diabetes in
the United States. American
Diabetes Association. Available at:
http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.
Accessed June 19, 2010.
(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of
risk factors for vascular disease among adults with previously
diagnosed diabetes. JAMA. 2004;291:335-42.
(v) Bays HE, Chapman RH and 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.
(vi) Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association.
Diabetes Care. 2007;30 Suppl 1:S48-65.
(vii) Anderson JW, Kendall CW and 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.
SOURCE Amylin Pharmaceuticals, Inc.