The FINANCIAL — Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) on June 7 announced additional results from a study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone and were treated with either monotherapy (stand-alone) BYETTA (exenatide) injection taken twice daily or placebo.
Study findings showed that patients treated with monotherapy exenatide showed statistically significant improvement in both A1C and weight loss with a lower incidence of nausea than in previous exenatide studies. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control. These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco.
In this 24-week randomized, double-blind, placebo-controlled, parallel study of 232 drug-naive patients (N=77 exenatide 5 mcg, N=78 exenatide 10 mcg, N=77 placebo) with type 2 diabetes who were treated with 5 mcg and 10 mcg of exenatide as a monotherapy reduced their A1C (a measure of average blood sugar over three months) by 0.7 percentage points and 0.9 percentage points, respectively, from 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 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.
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