CHICAGO, June 24 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced study results comparing treatment with BYETTA(R) (exenatide) injection with insulin glargine in people with type 2 diabetes. Study findings showed comparable improvements in blood sugar control with BYETTA and insulin glargine therapies, with weight loss and lower incidence of hypoglycemia associated with BYETTA. Patients in the study were also taking one of two commonly used oral medications. These findings were presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago.
This open-label crossover study of 114 people with type 2 diabetes compared treatment with BYETTA (5 mcg for 4 weeks and 10 mcg for 12 weeks) and oral medication (metformin or a sulfonylurea) with treatment with insulin glargine and oral medication on measures of blood sugar control, weight change and incidence of hypoglycemia during two 16-week periods. Treatment with BYETTA resulted in blood sugar control (measured by A1C reductions) comparable to treatment with insulin glargine (-1.43 percent vs. -1.41 percent, respectively).(1)
However, BYETTA treatment with metformin resulted in statistically significant lower risk of hypoglycemia (2.6 percent) than treatment with insulin glargine and metformin (17.4 percent). Additionally, there were seven episodes of severe hypoglycemia in three patients taking insulin glargine and no severe episodes during treatment with BYETTA, reflecting a lower overall risk of hypoglycemia. BYETTA treatment was also associated with a 5.7-pound weight loss from baseline, compared with a 1.3-pound weight gain among individuals in the insulin glargine group (a 7.0-pound difference between groups).
"Adding BYETTA to oral medication to achieve target blood sugar control levels can be an important next step in the management of type 2 diabetes," said Michael Trautmann, MD, lead investigator of this study and Medical Fellow of Eli Lilly and Company. "This study shows that adding BYETTA to oral medication before insulin use may help people with type 2 diabetes obtain the same glucose control as insulin and yet lose weight with reduced risk of hypoglycemia."
BYETTA was generally well-tolerated in this study, and side effects were consistent with those seen in previous studies. In clinical trials and post- approval adverse event reports, the most common side effect is mild-to- moderate nausea, which affects fewer than half of patients and usually decreases over time.
BYETTA is indicated for use as an adjunctive therapy for people with type 2 diabetes who are not achieving blood sugar control using metformin, a sulfonylurea, or a thiazolidinedione. Over three million prescriptions have been written in the U.S. since being approved by the Food and Drug Administration (FDA) in 2005.
For more information, visit http://www.byetta.com/.
About BYETTA
BYETTA is the first in a class of drugs called incretin mimetics 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 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. For full prescribing information, visit http://www.byetta.com/.
Safety and Tolerability
BYETTA improves glucose (blood sugar) control in patients with type 2 diabetes who are taking metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems with the stomach or food digestion, or those who have severe kidney disease. Before using BYETTA, patients should tell their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA has not been studied in children.
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients. BYETTA may reduce appetite, the amount of food eaten, and body weight. These are not all the side effects with BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
About Diabetes
Diabetes affects more than 20 million in the United States and an estimated 246 million adults worldwide.(2,3) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(4)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(5)
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. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego, California with over 1,600 employees nationwide. For more information about Amylin and the company's diabetes products, visit http://www.amylin.com/.
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. For more information about Lilly's current diabetes products visit http://www.lillydiabetes.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, Indiana, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://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 and the revenues generated from BYETTA may be affected by competition, unexpected new data, technical issues, clinical trials not confirming previous results or predicting future results, label expansion requests not being submitted in a timely manner or receiving regulatory approval, 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 scientific, regulatory and other issues and risks 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.
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adjunctively treated with metformin. Abstract # 0172-OR.
2. The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 14, 2007.
3. "All About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 14, 2007.
4. "Direct and Indirect Costs of Diabetes in the United States." American
Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed June 14, 2007.
5. Saydah SH, Fradkin J, Cowie CC. "Poor Control of Risk Factors for
Vascular Disease Among Adults with Previously Diagnosed Diabetes."
JAMA. 2004: 291(3), 335-342.
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