MEDIA RELEASE PR40202
Improvement in Beta-Cell Function Observed After Three Years of BYETTA(R) (exenatide) Injection
Therapy: Data Presented at ADA 2010
ORLANDO, Fla., June 26 /PRNewswire-AsiaNet/ --
Study Showed Improvements Compared to Insulin Glargine
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 exenatide injection or insulin glargine on
overall beta-cell function. (Beta cells are cells in the pancreas that
produce insulin.) Three years of exenatide 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 HbA1c similarly
(by 0.7 percentage points to 6.6 percent for exenatide and by 0.5 percentage
points to 6.9 percent for insulin glargine). HbA1c is a measure of average
blood sugar over three months. In addition, exenatide significantly reduced
body weight compared to insulin glargine (7.7 kilogram 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). Exenatide increased insulin sensitivity by 39 percent and
increased the disposition index, indicating an improvement in background
beta-cell function. Insulin glargine 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, exenatide treatment may help improve insulin production and
help people with type 2 diabetes control their blood sugar levels."
Study Design and Findings
In the first portion of the study, metformin-treated patients with type 2
diabetes were randomized to receive exenatide (n=36) or insulin glargine
(n=33) and measures of beta-cell function, blood sugar control and weight
change were compared. Baseline characteristics were age 59 +/- years; HbA1c
7.5 +/- 0.8 percent; BMI 31 +/- 4 kg/m2; weight 91.6 +/- 13.1 kilograms.
One-year study results, previously published in Diabetes Care, found that
patients receiving exenatide, compared to those treated with insulin
glargine, 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 (exenatide n=16; insulin
glargine 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 HbA1c similarly (to 6.6
+/- 0.2 percent and 6.9 +/- 0.2 percent for exenatide and insulin glargine,
respectively) after three years of treatment. After the four-week off-drug
period, the disposition index was increased in the exenatide-treated group
compared to baseline (+1.43 +/- 0.78). The disposition index was reduced with
insulin glargine (-0.99 +/- 0.65). In addition, exenatide increased insulin
sensitivity by 39 percent, while insulin glargine treatment showed no effect.
Thus, both insulin sensitivity and beta-cell function were improved after
exenatide therapy for three years.
About Diabetes
It is estimated that by 2010, diabetes will affect 284.6 million adults
worldwide and more than 55.4 million in Europe.(i, ii) Approximately 90 to 95
percent of those are affected by type 2 diabetes, a condition characterized
by failure of the pancreatic beta-cell to adequately respond to the increased
demands for insulin that occur as a result of obesity-related insulin
resistance.(iii)
Type 2 diabetes usually occurs in adults over the age of 40, but is
increasingly common in younger people.(iv) In virtually every high-income
country, diabetes is ranked among the leading causes of blindness, renal
failure and lower limb amputation as well as one of the leading causes of
death, largely because of a markedly increased risk of coronary heart disease
and stroke (cardiovascular disease).(v) In the European region, estimates
indicate that at least 106 billion USD will be spent on healthcare for
diabetes in 2010, accounting for 28 percent of global expenditure.(vi)
About exenatide Injection
Exenatide was the first approved incretin mimetic, a class of drugs for
the treatment of type 2 diabetes. Exenatide 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(vii).
Exenatide is approved in the European Union as adjunctive therapy to improve
blood sugar control in patients with type 2 diabetes who have not achieved
adequate glycaemic control on maximally tolerated doses of metformin and/or a
sulfonylurea, two common oral diabetes medications. Since the U.S. market
introduction in June 2005, more than one million patients worldwide have been
treated with exenatide.
Important Safety Information for exenatide
In clinical studies, the most common side effects were hypoglycaemia (low
blood sugar) when taken with a sulfonylurea, nausea (feeling sick), vomiting
and diarrhea. For the full list of all side effects reported with exenatide,
see the Package Leaflet. Exenatide should not be used in people who may be
hypersensitive (allergic) to exenatide or any of the other ingredients.
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(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. Further information on
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
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
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 exenatide, and/or the revenues generated from exenatide, 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 exenatide 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(R) is a registered trademark of Amylin Pharmaceuticals, Inc. All
other marks are the marks of their respective owners.
(i) The International Diabetes Federation Diabetes Atlas. Available at:
2010.
(ii) The International Diabetes Federation Diabetes Atlas. Available at:
(iii) 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.
(iv) The International Diabetes Federation Diabetes Atlas. Available at
2010.
(v) The International Diabetes Federation Diabetes Atlas. Available at
2010.
(vi) The International Diabetes Federation Diabetes Atlas. Available at:
(vii) 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.
SOURCE: Eli Lilly and Company
CONTACT: Amylin - Anne Erickson
+1-858-754-4443
Cell: +1-858-349-3195
Email: anne.erickson@amylin.com; or
Lilly - Tim Coulom
+1-317-655-2998
Cell: +1-317-544-9757
coulomtd@lilly.com
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