DURATION-4 Study Results: BYDUREON Efficacy and Tolerability Profile Extended to Monotherapy Treatment

This 26-week clinical study compared BYDUREON monotherapy to Januvia® (sitagliptin), Actos® (pioglitazone HCI) or metformin, three oral Type 2 diabetes medications commonly prescribed early in the treatment of Type 2 diabetes. Study participants were not achieving adequate A1c control using diet and exercise, and were not on any diabetes therapy when they entered the study. A1c is a measure of average blood sugar over three months. After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1c of 1.5 percentage points from baseline, which was greater than the reduction of 1.2 percentage points for Januvia. Patients randomized to metformin experienced a reduction in A1c of 1.5 percentage points, and patients receiving Actos experienced a reduction of 1.6 percentage points. Patients receiving BYDUREON, Actos and metformin treatment achieved an average A1c of less than 7 percent by study end.

Treatment with BYDUREON produced an average weight loss of 4.5 pounds, which was statistically significantly greater than the average 1.7 pounds patients lost with Januvia and the average 3.3 pounds patients gained with Actos. Patients receiving metformin experienced an average weight loss of 4.4 pounds.

"The majority of patients in this study reached an optimal A1c goal of less than seven percent, which is the glucose control target recommended by the American Diabetes Association," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "DURATION-4 reinforced that continued presence of exenatide helped these recently diagnosed patients to achieve glycemic control. The combination of efficacy, tolerability, and once weekly dosing in this monotherapy setting further supports the potential role BYDUREON can play in helping patients and physicians manage Type 2 diabetes."

More than 80 percent of patients in all treatment arms completed the study. There were no major hypoglycemia events in any treatment group. The most frequently reported adverse events among BYDUREON users were nausea (withdrawal rate less than 1 percent) and diarrhea; metformin, diarrhea and headache; Actos, upper respiratory tract infection, headache, hypertension and peripheral edema; and Januvia, upper respiratory tract infection and headache.

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for Type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in Byetta® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with Type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

The 26-week, double-blind, randomized, four-arm parallel study enrolled 820 patients who were not achieving adequate A1c control on diet and exercise. Patients had an average Type 2 diabetes diagnosis of two to three years. The patients were randomized as follows: BYDUREON (2 mg, once per week) (n=248); metformin (dose escalated up to 2,500 mg/day) (n=246); Actos (dose escalated up to 45 mg/day) (n=163); and Januvia (100 mg/day) (n=163). The primary endpoint was reduction in A1c, while secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health and patient-reported outcomes.

Amylin Pharmaceuticals, Inc.