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Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss
Date:6/7/2008

m an average baseline A1C of 7.9 and 7.8 percent, respectively. In the 5 mcg arm, 86 percent of study participants completed the study and in the 10 mcg arm, 87 percent completed the study. Sixty percent of the 5 mcg evaluable study participants and 61 percent of the 10 mcg evaluable study participants achieved or maintained an A1C of less than or equal to 7 percent at study end, a common target for good glucose control.

"Healthcare professionals and their patients with type 2 diabetes need a variety of treatment options to successfully manage the disease," said Jim Malone, M.D., Global Medical Director, Eli Lilly and Company. "These data are robust and show the important glucose lowering properties of BYETTA taken as monotherapy. If approved, this indication would give physicians the option to prescribe exenatide as a stand-alone treatment, which may allow for increased patient access to BYETTA."

This study was conducted following receipt of an approvable letter for a monotherapy indication from the FDA in 2005. In addition to the clinical studies included in the 2005 submission package, data from this study address requests by the FDA as a result of that approvable letter.

Treatment with exenatide also resulted in a statistically significant lowering of fasting glucose concentrations for EXE 5 mcg (-17.5+/-4 mg/dL) and EXE 10 mcg (-18.7+/-4 mg/dL) at endpoint compared with placebo (-5.2+/-4 mg/dL). A statistically significant weight loss was also noted of -6.1 pounds (EXE 5 mcg) and -6.8 pounds (EXE 10 mcg) compared with -3.2 pounds for placebo. In an oral glucose tolerance test conducted in a subset of patients (N=104), two hour serum glucose excursion decreased for EXE 5 mcg (-18.4+/-14 mg/dL) and EXE 10 mcg (-55.1+/-13 mg/dL), while this measure increased (+4.5+/-14 mg/dL) in patients treated with placebo.

In addition, fasting serum lipid profiles, including total cholesterol and high- and low-density lipoprotein, remained unchanged
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