Healthcare Industry News: metformin
News Release - June 12, 2006
BYETTA(R) Extension Study Shows Sustained Improvements in Blood Glucose Control and Progressive Weight Loss After Two YearsWASHINGTON, D.C., June 10 (HSMN NewsFeed) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) today announced two-year study results showing that BYETTA® (exenatide) injection sustained improvements in blood sugar control and reduced body weight in people with type 2 diabetes who previously did not achieve adequate control of their blood sugar on common oral medications. These findings were presented at the 66th Annual Scientific Sessions of the American Diabetes Association (ADA) in Washington, D.C.
BYETTA (pronounced bye-A-tuh), was approved in April 2005 as an adjunctive therapy for patients who are not achieving blood sugar control on metformin and/or a sulfonylurea.
After two years of treatment, patients sustained an average hemoglobin A1C (A1C) reduction of 1.1 percent from baseline. This A1C reduction compares to an A1C reduction of 1.1 percent at the end of the initial 30-week clinical trial, demonstrating sustained efficacy over the two-year period. A1C measures a person's average glucose level over a three-month period and is often used by doctors to assess blood glucose management. The ADA recommends a target A1C of less than 7 percent; fifty percent of patients in this study reached an A1C of 7 percent or less, and 31 percent achieved an A1C of 6.5 percent or less after two years of treatment.
Average weight loss improved to 10 pounds from the average of five pounds seen after 30 weeks. Fasting blood glucose was reduced 25 mg/dL.
Additionally, HOMA-B, a clinical measurement of beta-cell function, was assessed in a subset of study participants. Beta cells are the insulin producing cells in the pancreas. Participants treated with BYETTA showed significant improvement in HOMA-B from study start to end after two years.
"The benefit of controlling blood sugar levels and the associated weight reduction demonstrated by patients taking BYETTA is significant since these are important clinical goals that many patients have difficulty achieving long term," said Dr. Robert Henry, lead investigator and Chair of the Veterans Medical Research Foundation Advisory Research Committee. "Results from these long-term data support BYETTA's continuing ability to help people with type 2 diabetes better manage their disease."
There were 283 patients from the original 30-week exenatide pivotal trials that completed 2 years of BYETTA treatment in open-label extension trials. All patients in this "completer cohort" received BYETTA twice daily in addition to their current diabetes treatment. Data collected and assessed over two years demonstrated that long-term administration of BYETTA in combination with metformin, a sulfonylurea or both, resulted in sustained reductions in blood sugar and progressive reductions in weight.
BYETTA is the first incretin mimetic, a class of drugs for the treatment of type 2 diabetes. BYETTA 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.(1)
Safety and Tolerability
Adverse events associated with BYETTA are generally mild to moderate in intensity. In clinical trials, the most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy, the frequency and severity of nausea decreased over time in most patients.
Patients receiving BYETTA in combination with a sulfonylurea may be at a higher risk of hypoglycemia or low blood sugar. To reduce this risk, decreasing the dose of sulfonylurea may be considered. When patients begin taking BYETTA, the symptoms, treatment and conditions that predispose development of hypoglycemia should be explained to them, and the patient's usual instructions for hypoglycemia management should be reviewed and reinforced.
Patients should also be advised that treatment with BYETTA may lead to a reduction in appetite, food intake and/or body weight, and that there is no need to modify the dosing regimen due to such effects.
BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.
For complete safety profile and other important prescribing considerations, visit www.BYETTA.com.
About Incretin Mimetics
Incretin mimetics is 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. BYETTA is the first FDA-approved incretin mimetic.
Diabetes affects an estimated 194 million adults worldwide(2) and more than 20 million in the United States.(3) Approximately 90 to 95 percent of those affected have 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.(4) Diabetes is the sixth leading cause of death by disease in the United States(3) and costs approximately $132 billion per year in direct and indirect medical expenses. Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(3)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of diabetes patients do not achieve target hemoglobin A1C levels (less than 7 percent according to ADA guidelines(5)) with their current treatment regimen.(6)
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first- in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin is located in San Diego, California with over 1200 employees nationwide. Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in metabolism is available at www.amylin.com.
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. 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 BYETTA may be affected by unexpected new data, technical issues, or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or other issues inherent in the commercialization of pharmaceutical products. 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 undertake no duty to update these forward-looking statements.
(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 Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed April 12, 2005.
(3) Centers for Disease Control and Prevention, National Diabetes Fact Sheet. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf.
(4) 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.
(5) American Diabetes Association. Standards of medical care in diabetes- 2006. Diabetes Care 2006;29:S4-42.
(6) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999;22:403-408.
Source: Eli Lilly
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