COMUNICADO: Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) (insulin glargine) in Head-to-Head DURATIO

Actualizado 21/07/2009 1:58:21 CET

SAN DIEGO, INDIANAPOLIS, CAMBRIDGE, Massachusetts, July 20 /PRNewswire/ --

-- Significant Reductions in Weight and Fewer Reports of Hypoglycaemia Compared to Insulin Glargine Also Observed

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive results from a study comparing subjects randomized to either exenatide once weekly or Lantus(R) (insulin glargine). Patients randomized to exenatide once weekly experienced a statistically superior reduction in HbA1c, a measure of average blood sugar over three months, of 1.5 percentage points from baseline, compared to a reduction of 1.3 percentage points for insulin glargine after completing 26 weeks of treatment. At the end of the study, patients treated with exenatide once weekly achieved a mean HbA1c of 6.8 percent compared with a mean HbA1c of 7.0 percent in those treated with insulin glargine. Treatment with exenatide once weekly also produced a statistically significant difference in weight, with a mean weight loss of 2.6 kilograms at 26 weeks, compared with a mean weight gain of 1.4 kilograms for insulin glargine, a difference of 4.0 kilograms between the treatments.

In addition, although patients treated with exenatide once weekly experienced a greater reduction in blood glucose than those treated with insulin glargine, they also reported significantly fewer episodes of confirmed hypoglycaemia.

These intent-to-treat results were from DURATION-3, the third in a series of studies designed to test the superiority of exenatide once weekly, an investigational diabetes therapy, as compared to other diabetes medications. This 26-week open label clinical study compared exenatide once weekly to once-daily doses of insulin glargine in 467 patients with type 2 diabetes taking stable doses of metformin alone or in combination with a sulfonylurea. Exenatide once weekly was administered once a week in a fixed dose while insulin glargine was administered daily in a variable dose determined by patient blood sugar levels.

"Exenatide once weekly outperformed insulin glargine in this superiority study by meeting its primary endpoint," stated Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Both treatment arms started with a baseline HbA1c of 8.3 percent and exenatide once weekly provided statistically significantly greater HbA1c reduction, weight loss versus weight gain and fewer episodes of hypoglycaemia."

More than 90 percent of patients completed the study. During the 26-week treatment period, the most frequently reported adverse events were upper respiratory infection, including nasopharyngitis, in both treatment arms, as well as gastrointestinal events, including nausea, in the exenatide once weekly treatment group. Patients treated with exenatide once weekly experienced less confirmed hypoglycaemia: the incidence of hypoglycaemia was 4 percent with exenatide once weekly versus 19 percent with insulin glargine for patients on metformin background therapy, and 20 percent with exenatide once weekly versus 44 percent with insulin glargine for patients on metformin and a sulfonylurea background therapy, differences that are statistically significant in both treatment groups.

The companies plan to present the full data set at a major medical meeting and submit the data for publication.

Study Design

The 26-week open label, superiority study included 467 subjects with type 2 diabetes who were not achieving adequate glucose control using metformin therapy alone or in combination with a sulfonylurea. Subjects were randomized to receive exenatide once weekly 2 milligrams by subcutaneous injection weekly or insulin glargine injections administered daily in a variable dose determined by patient blood sugar levels. There was no lead-in or wash-out period. The primary endpoint was reduction in HbA1c; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycaemia and patient-reported outcomes. Subjects in both treatment groups are continuing in an open-ended extension study.

About Diabetes

Diabetes affects an estimated 246 million adults worldwide and more than 53 million in Europe.(1)_(2) 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.(3)

Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(4) 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 (50 percent of people with diabetes die of cardiovascular disease).(5) The total cost of caring for people with diabetes in Europe is estimated between 28 billion and 53 billion Euros per year.(6)

About Amylin, Lilly and Alkermes

Amylin, Lilly and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary technology for long-acting medications. Exenatide once weekly is not currently approved by any regulatory agencies.

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 potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California.

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 healthcare 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 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.

Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.


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