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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

and blood pressure levels improved. Systolic blood pressure decreased from baseline to endpoint by -3.7+/-1.2 mm Hg in the 5 mcg exenatide group (P=0.037; vs placebo) and also -3.7+/-1.2 mm Hg in the 10 mcg exenatide group (P=0.037; vs placebo), compared with -0.3+/-1.2 mm Hg for placebo (means +/- SEM). Diastolic blood pressure decreased from baseline to endpoint by -0.8+/-0.7 mm Hg in the 5 mcg exenatide group (P=0.619; vs placebo) and -2.3+/-0.7 mm Hg in the 10 mcg exenatide group (P=0.046; vs placebo), compared with -0.3+/-0.7 mm Hg for placebo (means +/- SEM).

There was an incidence of reported nausea in both the 5 mcg and 10 mcg arms of 3 and 13 percent, respectively, which is a lower incidence than what was observed in previous studies, where exenatide has been used in combination with other diabetes therapies. There were no instances of severe hypoglycemia. The overall incidence of hypoglycemia was similar to that seen in studies where exenatide was used in conjunction with metformin only.

Study Population

The 24-week, randomized study included 232 patients with type 2 diabetes who were not achieving adequate glucose control using diet and exercise without previous use of antidiabetes agents. Study participants were randomized to receive subcutaneous injections of placebo, 5 mcg exenatide, or 10 mcg exenatide twice daily without taking any oral antidiabetes agents. Patients randomized to 10 mcg exenatide received 5 mcg injections for the first four weeks, and increased to 10 mcg injections for the final 20 weeks.

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by peop
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SOURCE Eli Lilly and Company
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