Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

After three years of treatment, both therapies reduced A1C similarly (by 0.7 percentage points to 6.6 percent for BYETTA and by 0.5 percentage points to 6.9 percent for Lantus). A1C is a measure of average blood sugar over three months. In addition, BYETTA significantly reduced body weight compared to Lantus (17-pound difference between groups). After completion of three years of therapy, a four-week off-drug period followed to allow assessment of parameters of metabolic state including beta-cell function. Beta-cell function was assessed using a calculated disposition index (insulin secretion adjusted for insulin sensitivity). BYETTA increased insulin sensitivity by 39 percent and increased the disposition index, indicating an improvement in background beta-cell function. Lantus had no effect on insulin sensitivity or disposition index.

"Type 2 diabetes is a progressive disease in which insulin production typically decreases over time," said Michaela Diamant, M.D., professor of diabetology, director, Diabetes Center VUMC, Amsterdam, the Netherlands, and principal investigator of the study. "These findings suggest that with extended use, BYETTA treatment may help improve insulin production and help people with type 2 diabetes better control their blood sugar levels."

Study Design and Findings

In the controlled portion of the study, metformin-treated patients with type 2 diabetes were randomized to receive BYETTA>Diabetes Care, found that patients receiving BYETTA, compared to those treated with Lantus, showed significant improvements in beta-cell function. However, the improvements were not sustained following an initial four-week off-drug period.

In this study, a total of 46 patients entered the two-year open-label extension period, and 36 completed the study.