Eli Lilly and Company

Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Insulin Glargine

Athens, Greece (ots/PRNewswire) - -- Patients on exenatide also lost weight, while glargine patients gained weight -- Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) today announced results from a study indicating that exenatide improves blood sugar levels as effectively as insulin glargine (Lantus(R), Sanofi-Aventis) for people with type 2 diabetes failing to achieve acceptable blood sugar control on both metformin and a sulfonylurea, two common oral diabetes medications. Both treatments were effective in lowering blood sugar, and patients taking exenatide experienced weight reductions while those on insulin glargine gained weight. The findings were presented at the 41st annual meeting of the European Association for the Study of Diabetes in Athens, Greece. Exenatide is the first in a new class of medicines known as incretin mimetics and was approved for use in the United States by the U.S. Food and Drug Administration on 28 April 2005 for the treatment of type 2 diabetes. The U.S. is the first country in the world that has received regulatory approval for exenatide. It is not approved for use in Europe. Lilly and Amylin anticipate submissions for regulatory review in other countries in the near future. In this study, patients in each treatment group -- either exenatide or insulin glargine -- lowered their average blood sugar (glucose) levels, as measured by hemoglobin A1C (A1C), by approximately 1 percent from baseline after six months of therapy. A1C measures a person's average glucose level over a three-month period and is often used by healthcare providers to assess blood glucose management. The American Diabetes Association recommends a target A1C of less than 7 percent. Approximately half of the patients in each treatment group achieved an A1C of 7 percent or less. The study also showed that patients on exenatide lost an average of 2.3 kg, while patients on insulin glargine gained an average of 1.8 kg. Weight gain is a common side effect of insulin therapy. In addition, exenatide reduced peak glucose levels after meals better than insulin glargine. In contrast, insulin glargine was associated with lower fasting glucose levels. Both the exenatide and insulin glargine groups had similar rates of symptomatic hypoglycemia (low blood sugar). Patients in both treatment groups continued their oral therapy as well, which included a sulfonylurea, a therapy known to cause hypoglycemia when used alone. "This is the first comparator study in which a non-insulin treatment for diabetes has demonstrated similar blood glucose control to insulin for patients who are failing to achieve treatment targets on oral medications," said Professor Robert Heine, Director of the Diabetes Center, VU University Medical Center in the Netherlands, and a lead author of the study's abstract. "When considering the weight loss and achieved glucose control, the results of this study demonstrate that exenatide could potentially be an effective tool for the management of type 2 diabetes patients who cannot control their blood sugar using oral medications." Key Findings The primary objective of the study was to determine whether comparable glycemic control can be achieved in both groups, as evaluated by a change in A1C levels from baseline. Additional endpoints of the study included effects on weight, postprandial glucose excursions and incidence of hypoglycemia. A1C reduction: - At the end of the study, both treatment groups had achieved similar A1C reductions. Exenatide lowered A1C 1.0 percent while insulin glargine lowered A1C 1.1 percent. - Forty-six percent of patients in the exenatide group achieved the target A1C level less than or equal to 7 percent compared to 48 percent in the insulin glargine group. - When measured against the American Association of Clinical Endocrinologist recommended target A1C of less than or equal to 6.5 percent, 31 percent of patients in the exenatide group achieved this level compared to 24 percent in the insulin glargine group. Weight change: - Weight loss in the exenatide arm: Patients using exenatide showed an average weight reduction of 2.3kg (5.1 pounds). - Weight gain in the insulin glargine arm: On average, patients using insulin glargine gained 1.8kg (4.0 pounds). Postprandial excursions (post-meal blood glucose levels): - As measured by seven-point glucose monitoring, exenatide reduced postprandial excursions (post-meal blood glucose levels) following breakfast and dinner. In contrast, insulin glargine predominantly reduced fasting glucose (at least eight hours after a meal). Hypoglycemia: - Rates of symptomatic hypoglycemia were similar between treatment groups. The most common adverse event for exenatide was nausea (57 percent), which was generally mild-to-moderate and tended to decrease in frequency and severity over time. Six percent of exenatide treated subjects discontinued due to nausea. Study Design/Protocol More than 500 patients were involved in the 26-week, multi-center, open-label, randomized, two-arm, parallel trial. The trial was designed to determine if exenatide can be used safely and effectively in combination with metformin plus a sulfonylurea as an alternative to insulin glargine for type 2 diabetes patients. Patients were randomized into two arms. One arm received a fixed dose of exenatide (5 micrograms twice-a-day for first four weeks, 10 micrograms twice-a-day for remainder of study, n=283) in conjunction with metformin and a sulfonylurea. The second arm received insulin glargine once daily beginning at 10 insulin units per day (n=268) in conjunction with metformin and a sulfonylurea. The glargine dose was titrated based on finger-stick blood glucose monitoring to achieve a pre-specified target fasting blood glucose level. Because of the fixed dosing of exenatide, patients in that arm required no dose titration or additional finger-stick testing. The A1C baselines for the two groups were 8.2 plus or minus 1.0 percent for exenatide and 8.3 plus or minus 1.0 percent for insulin glargine. About exenatide Exenatide is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and 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 stomach, liver, pancreas and brain that work in concert to regulate blood sugar.(1) Exenatide was approved by the U.S. FDA for use by people in the United States with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications metformin, a sulfonylurea or both. The U.S. is the first country in the world that has received regulatory approval for exenatide. It is not approved for use in Europe. Lilly and Amylin anticipate submissions for regulatory review in other countries in the near future. About Incretin Mimetics Incretin mimetics is a new class of therapeutics for use in the fight against type 2 diabetes. An incretin mimetic works to mimic the antidiabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. Exenatide is the first U.S. FDA-approved agent of this new class of medications. About Diabetes Diabetes affects an estimated 194 million adults worldwide(2) and around 48,4 million in Europe.(2) Of those affected approximately 85 to 95 percent have type 2 diabetes, a condition where the body does not produce enough insulin and/or the cells in the body do not respond normally to insulin.(3) Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(3) In virtually every developed society, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation, as well as death through its effects on cardiovascular disease (70-80 percent of people with diabetes die of cardiovascular disease)(4). The calculated estimates of the costs of diabetes care in Europe amount to 42.8 million International Dollars per year. (5) About Lilly and Amylin 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 health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. 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, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. P-LLY 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 future clinical trials may not replicate previous trial results; risks that exenatide may not prove to be an important new therapeutic option, additional indications for exenatide may not be received, or exenatide may be affected by unexpected new data or technical issues. The potential for exenatide may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance and any issues related to manufacturing and supply. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed SEC documents such as their Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements. Study shows exenatide improves blood sugar levels as effectively as insulin glargine REFERENCES (1) 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. (2) The International Diabetes Federation, Prevalence / All diabetes. Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/ . (3) The International Diabetes Federation, Types of Diabetes. Available at http://www.eatlas.idf.org/Types_of_diabetes/#Type2diabetes (4) The International Diabetes Federation, Complications. Available at http://www.eatlas.idf.org/Complications/ (5) The International Diabetes Federation, Diabetes Atlas, Second edition. The Economic Impact of Diabetes. 2003: 186. (Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO ) ots Originaltext: Eli Lilly and Company; Amylin Pharmaceuticals, Inc. Im Internet recherchierbar: http://www.presseportal.ch Contact: Scott MacGregor of Eli Lilly and Company, +1-317-651-1494, +1-317-332-5557 (mobile) Photo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO PRN Photo Desk, photodesk@prnewswire.com

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