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Monotherapy BYETTA(R) (Exenatide) As Stand Alone Therapy

Posted: Wednesday, June 11, 2008

Submitted to FDA for Stand-Alone Therapy in Q1 2008, studies show that exenatide can lower A1c 0.7 to 0.9 points as a monotherapy. 
There are 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(R) (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.

In this 24-week randomized, double-blind, placebo-controlled, parallel study  patients  who received Byetta as a monotherapy reduced their A1C by 0.7 percentage points and 0.9 percentage points, respectively, from an average baseline A1C of 7.9 and 7.8 percent, respectively 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."

Treatment with exenatide also resulted in a statistically significant lowering of fasting glucose concentrations for at endpoint compared with placebo.  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 while this measure increased (+4.5+/-14 mg/dL) in patients treated with placebo.

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 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 and -2.3+/-0.7 mm Hg in the 10 mcg exenatide group, compared with -0.3+/-0.7 mm Hg for placebo.

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.

Source: Diabetes In Control: These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco

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