MEDIA RELEASE PR40203
Type 2 Diabetes Patients with Long-Standing Disease Achieved Glycaemic Control When
BYETTA(R) (exenatide) Injection Was Added to Insulin Glargine
ORLANDO, Fla., June 26 /PRNewswire-AsiaNet/ --
Study Presented at ADA 2010
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company
(NYSE: LLY) today announced results from the first double-blind,
placebo-controlled clinical study to evaluate exenatide injection added to
insulin glargine, which showed patients with type 2 diabetes achieved glucose
targets without weight gain or increasing their risk of hypoglycaemia. These
findings were presented at the 70th Annual Scientific Sessions of the
American Diabetes Association (ADA) in Orlando, Fla.
In the study, patients receiving insulin glargine, with or without oral
agents, were randomized to receive exenatide or placebo in addition to
aggressive insulin titration. After 30 weeks of treatment, HbA1c decreased by
1.7 percentage points in patients adding exenatide, compared with a decrease
of 1.0 percentage point in patients treated with insulin alone. Weight
decreased in patients adding exenatide by 1.81 kilograms, compared with an
increase of 0.90 kilograms in patients treated with insulin alone. Fasting
plasma glucose and hypoglycaemia were similar between treatment groups.
"Even in this population of patients who were poorly controlled on
insulin therapy, the addition of exenatide to optimized basal insulin therapy
provided exactly what we hoped for - improved control of blood sugar
throughout the day, weight loss and no increased risk of hypoglycaemia as
compared to optimized basal insulin treatment alone," said John Buse, M.D.,
Ph.D., Professor of Medicine, Director of the Diabetes Care Center, and Chief
of the Division of Endocrinology at the University of North Carolina School
of Medicine in Chapel Hill. "This study showed exenatide may provide a
complementary addition to basal insulin for these hard-to-treat type 2
diabetes patients."
Exenatide is not currently approved for this dosing regimen. Results from
this study will form the basis for a supplemental New Drug Application (sNDA)
to the U.S. Food and Drug Administration (FDA). The filing is planned for the
end of 2010.
Study Design and Findings
The double-blind, placebo-controlled study enrolled 261 patients (mean
age: 59 years old; weight: 93.89 kilograms; HbA1c: 8.4 percent; diabetes
duration: 12 years; insulin dose 48 units) who were randomized to exenatide
10 micrograms (n=137) or placebo (n=122). Groups were generally comparable at
baseline. Insulin dose was decreased by 20 percent if a patient's HbA1c was <
/ = 8 percent or maintained if a patient's HbA1c was >8 percent for five
weeks, then titrated to achieve a target fasting glucose of <5.55 mmol/l.
Primary endpoint was change in HbA1c, a measure of average blood sugar over
three months. Continuous glucose monitoring (n=23) and 7-point glucose
profiles demonstrated significant postprandial effects with exenatide
compared with insulin alone. Insulin dose increased more in the placebo group
(20 +/- 2 units) than in the exenatide group (13 +/- 2 units) to achieve the
fasting glucose target.
Safety Profile
Overall, nausea was the most common event during the 30-week treatment
period and decreased over time. Nausea occurred in 41 percent of patients
treated with exenatide compared with 8 percent of patients treated with
insulin alone. Hypoglycaemia was similar for both groups; major hypoglycaemia
occurred twice in one patient receiving insulin alone.
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
anne.erickson@amylin.com; or
Lilly - Tim Coulom
+1-317-655-2998
Cell: +1-317-544-9757
Email: coulomtd@lilly.com
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