501 patients were enrolled in the 52-week, multi-center, open-label, randomized trial. The trial was designed to determine if exenatide can be used as safely and effectively as biphasic insulin aspart in patients with type 2 diabetes inadequately treated with metformin plus a sulfonylurea. Study participants were randomized into two treatment arms. The first group received a dose of exenatide (5 micrograms twice-a-day for first four weeks, then 10 micrograms twice-a-day for the remainder of the study), in conjunction with metformin and a sulfonylurea. The second group received biphasic insulin aspart (titrated to achieve an optimal balance between glycemic control and risk of hypoglycemia as dictated by best clinical practice), again with metformin and a sulfonylurea. The average HbA1C at baseline was 8.6 percent in both treatment groups.

During the one year (52-week) study, patients using exenatide showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose, and hemoglobin A1C (HbA1C). Exenatide treatment also resulted in an average reduction in body weight.

Thirty-two percent of study participants using exenatide reached target HbA1C of 7 percent or less and 18 percent of patients in the exenatide group achieved an HbA1c level of 6.5% compared to 9 percent in the biphasic insulin aspart group. These Patients on exenatide lost an average of 2.5 kilograms (5.5 pounds), while those receiving biphasic insulin aspart gained an average of 2.9 kilograms (6.4 pounds). Weight gain is a common side effect of insulin therapy. In addition, exenatide reduced peak blood sugar levels after meals. Both treatments were associated with low rates of daytime and nighttime hypoglycemia (low blood sugar).

"These data show that exenatide, without the inconvenience of dose titration, is a potential alternative to biphasic insulin aspart for the treatment of patients with type 2 diabetes not adequately treated with metformin and a sulfonylurea, commonly used oral antidiabetic agents."

Other Key Findings: Reduced fasting and postprandial blood sugars greater then biphasic insulin aspart. Wt. loss in the exenatide arm: Patients treated with exenatide experienced an average weight reduction of 2.5 kilograms (5.5 pounds).

Weight gain in the biphasic insulin aspart: On average, patients treated with insulin gained 2.9 kilograms (6.4 pounds). After 52 weeks, the total weight difference between treatments was -5.4 kilograms (11.9 pounds).

The most common adverse event for exenatide was nausea (33.2 percent exenatide, 0.4 percent biphasic insulin aspart), which was generally mild-to-moderate and tended to decrease in frequency and severity over time.

Findings were presented at the 42nd annual meeting of the European Association of the Study of Diabetes (EASD) in Copenhagen, Denmark.

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