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 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.
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.
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 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 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: http://www.diabetesatlas.org/content/regional-overview. Accessed on June 9,2010.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/europe. Accessed on June 9, 2010.
(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 http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on June 9,2010.
(v) The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on June 9,2010.
(vi) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/europe. Accessed on June 9,2010.
(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
Lilly – Tim Coulom