Eli Lilly and Company

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

    Copenhagen, Denmark (ots/PRNewswire) -

    - Patients Taking Exenatide Lost Weight While Patients Taking Insulin Glargine 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 metformin or a sulfonylurea, two common oral diabetes medications. This is the third study demonstrating that exenatide can control blood sugar as effectively as insulin.(1)(2)

    In this 32-week cross-over study, each patient received treatment with exenatide and insulin glargine for 16 weeks. Patients experienced similar reductions in hemoglobin A1C (HbA1C), or blood sugar levels, when treated with exenatide or insulin glargine. Forty percent of study participants reached target HbA1C of 7 percent or less when treated with exenatide compared to forty-one percent when they were treated with insulin glargine. Less than 7 percent is the target for good glucose control as recommended by American Diabetes Association (ADA). Twenty-four percent of patients on exenatide achieved target HbA1C of less than 6.5 percent compared with 14 percent when treated with glargine. The International Diabetes Federation (IDF) recommends a target HbA1C of 6.5 percent or less. These findings were presented at the 42nd annual meeting of the European Association of the Study of Diabetes (EASD) in Copenhagen, Denmark.

    Exenatide treatment also resulted in an average reduction in body weight. After taking exenatide, patients on exenatide lost an average of 1.95 kilograms (4.3 pounds), but after taking insulin glargine, patients gained an average of 0.35 kilograms (0.77 pounds). In addition, exenatide significantly reduced postprandial glucose levels (peak levels after meals) compared to insulin glargine. Exenatide and insulin glargine treatment resulted in similar rates of hypoglycemia (low blood sugar) with a sulfonylurea, a therapy known to cause hypoglycemia when used alone. In combination with metformin, patients receiving exenatide treatment experienced fewer cases of hypoglycemia than when they were treated with insulin glargine.

    "The results of this study demonstrate that exenatide could potentially be an effective treatment option for the management of type 2 diabetes patients who cannot control their blood sugar using oral medications," said Professor Anthony Barnett of the University of Birmingham and Birmingham Heartlands Hospital in the United Kingdom and a lead author of the study. "In addition to helping patients lower their HbA1C as effectively as insulin glargine, exenatide also helped patients lose weight -- an important factor in the management of type 2 diabetes."

    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 in April 2005 for the treatment of type 2 diabetes. Exenatide is injected twice daily. The U.S. is the first country that has received regulatory approval for exenatide. In late 2005, Lilly submitted exenatide for approval in the European Union.

    Key Findings

    A1C reduction:

    -- Both treatments achieved similar HbA1C reductions. Exenatide lowered HbA1C by 1.43 percent while insulin glargine lowered HbA1C by 1.41 percent.

    -- When measured against the target HbA1C of less than or equal to 7 percent, 40 percent of patients achieved target HbA1C level of less than or equal to 7 percent when treated with exenatide, compared to 41 percent when treated with insulin glargine.

    -- When measured against the target HbA1C level of less than or equal to 6.5 percent, 24 percent of patients receiving exenatide achieved this level compared to 14 percent when receiving insulin glargine.

    Glucose measurements:

    -- As measured by seven-point glucose monitoring, exenatide reduced postprandial excursions, the rise of glucose after meals, following breakfast and dinner.

    -- The fasting blood glucose was significantly decreased from baseline for both treatments (exenatide, 3.04 mmol/L; insulin glargine, 4.17 mmol/L).

    Weight change:

    -- Weight loss in the exenatide arm: Patients treated with exenatide experienced an average weight reduction of 1.95 kilograms (4.3 pounds).

    -- Weight gain in the insulin glargine arm: On average, patients treated with insulin glargine gained 0.35 kilograms (0.77 pounds).


    -- Hypoglycemia occurred in a greater percentage of patients treated with a sulfonylurea (30 percent exenatide, 35 percent insulin glargine) compared with patients treated with metformin (3 percent exenatide, 17 percent insulin glargine).

    Other adverse events:

    -- The most common adverse event for exenatide was nausea (33.1 percent for exenatide, 3.9 percent for insulin glargine), which was generally mild-to-moderate and tended to decrease in frequency and severity over time.

    Study Design/Protocol

    141 patients were enrolled in the 32-week, multi-center, open-label, randomized, two-arm, cross-over trial. The trial was designed to determine if exenatide can be used as safely and effectively as insulin glargine in type 2 diabetes patients inadequately treated with metformin or a sulfonylurea.

    Study participants were randomized during two, 16-week treatment periods. One group first received a dose of exenatide (5 micrograms twice-a-day for first four weeks, then 10 micrograms twice-a-day for 12 weeks), in conjunction with metformin or a sulfonylurea, and then crossed over to insulin glargine. The second group first received insulin glargine (iterated using a treat-to-target algorithm to a fasting blood glucose of less than or equal to 5.6 mmol/L) for 16 weeks, again with metformin or a sulfonylurea, and then crossed over to exenatide. The average HbA1C at baseline was 8.9 percent.

    About exenatide

    Exenatide is the first incretin mimetic, a new 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.(3)

    About Incretin Mimetics

    Incretin mimetics are a distinct class of treatment in the fight against diabetes. An incretin mimetic works to mimic the anti-diabetic 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 FDA-approved incretin mimetic.

    About Diabetes

    Diabetes affects an estimated 194 million adults worldwide(4) and around 48.4 million in Europe.(5) Approximately 90 to 95 percent of those are affected by type 2 diabetes, a condition characterized by failure of the pancreatic beta cells to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.(6) Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(5) 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)(7). The calculated estimates of the costs of diabetes care in Europe amount to 42.8 million International Dollars per year.(8)

    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, IN, 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. Amylin's research and development activities leverage the company's expertise in metabolism to develop promising therapies to treat diabetes, obesity and cardiovascular disease. Amylin is located in San Diego, California with over 1200 employees nationwide.

    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, European approval for exenatide or regulatory approval of 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 Quarterly Reports on Form 10-Q. Amylin and Lilly disclaim any obligation to update these forward-looking statements.



    (1) Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: A randomized trial. Annals of Internal Medicine. 2005; 143(8):559-69.

    (2) Nauck MA, Duran S, Kim D, Johns D, Festa A. Effects of exenatide compared with twice-daily biphasic insulin aspart in patients with type 2 diabetes using sulphonylurea and metformin. Data disclosure at the 42nd annual meeting of the European Association of the Study of Diabetes. September 14, 2006.

    (3) 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.

    (4) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2 FD3-87B73F80BC22682A. Accessed April 12, 2005.

    (5) The International Diabetes Federation, Prevalence / All diabetes. Available athttp://www.eatlas.idf.org/Prevalence/All_diabetes/.

    (6) 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.

    (7) The International Diabetes Federation, Complications. Available athttp://www.eatlas.idf.org/Complications/.

    (8) The International Diabetes Federation, Diabetes Atlas, Second edition. The Economic Impact of Diabetes. 2003: 186.

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