The companies are specifically seeking approval for use of their drug as an add-on therapy to a common class of oral diabetes medications called thiazolidinediones, or TZDs, for the treatment of people with type 2 diabetes who are not achieving acceptable blood sugar control.
The drug is already approved as an add-on therapy for treatment of people not achieving acceptable blood sugar control despite using the commonly prescribed diabetes medications metformin, a sulfonylurea or a combination of both.
Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.