Study Design and Findings

The double-blind, placebo-controlled study enrolled 261 patients (mean age: 59 years old; weight: 208 pounds; A1C: 8.4 percent; diabetes duration: 12 years; insulin dose 48 units) who were randomized to BYETTA 10 microgramss A1C was < 8 percent or maintained if a patient's A1C was > 8 percent for five weeks, then titrated to achieve a target fasting glucose of < 100 mg/dL. Primary endpoint was change in A1C, a measure of average blood sugar over three months. Continuous glucose monitoring>

Safety Profile

Nausea was the most common event during the 30-week treatment period and decreased over time. Nausea occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin alone. Hypoglycemia was similar for both groups; major hypoglycemia occurred twice in one patient receiving insulin alone.

SOURCE Amylin Pharmaceuticals, Inc.