Byetta (exenatide) is an injectable diabetes medicine that helps control blood sugar levels and it helps pancreas produce insulin more efficiently.
Amylin Pharma and Eli Lilly said that Byetta sNDA is based on a double-blind, placebo-controlled clinical study evaluating Byetta added to Lantus (insulin glargine).
The result of the study suggested that many hard-to-treat patients with type 2 diabetes who were poorly controlled on basal insulin therapy with or without metformin and/or a TZD achieved A1C control without weight gain or increasing their risk of hypoglycemia.
Amylin Pharma senior vice president, chief medical officer Orville Kolterman said that if approved for this expanded use, Byetta may provide a complementary addition to basal insulin to improve overall blood sugar control with no weight gain and no increased risk of hypoglycemia.
"The combination may also offer a mealtime treatment option that is taken only twice a day and does not require dosing titration," Kolterman said.