FDA Okays Exenatide as Adjunct to Insulin Glargine

October 24, 2011

October 24, 2011 — Exenatide injection (Byetta, Amylin Pharmaceuticals, Inc, and Eli Lilly and Company) received approval from the US Food and Drug Administration as an add-on therapy to insulin glargine for patients with type 2 diabetes who are not achieving adequate glycemic control with the basal insulin analogue alone, the agency announced last week.

The expanded indication for exenatide assumes that patients also are managing their disease with diet and exercise. They can take exenatide whether or not they are being treated with metformin alone or in combination with a thiazolidinedione (TZD).

The US Food and Drug Administration initially approved exenatide in 2005 as an adjunctive therapy for patients with type 2 diabetes who were not achieving adequate glycemic control despite taking metformin, a sulfonylurea, or the combination of metformin and a sulfonylurea. TZDs and the metformin–TZD combo were added to the list of medications in 2006.


A manmade version of a protein found in the saliva of the Gila monster, exenatide mimics glucagon-like peptide 1, a gastrointestional hormone that helps stabilize glucose levels. Patients with diabetes do not have enough of this hormone.

A study first published online December 6, 2010, in the Annals of Internal Medicine reported that patients receiving exenatide in addition to insulin glargine lowered their hemoglobin A1c levels by 1.7% over the course of 30 weeks compared with 1.0% for patients on insulin glargine who received a placebo. This improved control occurred without increased hypoglycemia or weight gain. Although patients taking insulin glargine alone gained 1.0 kg, those also receiving exenatide lost 1.8 kg.

The most common adverse event was nausea, which occurred in 41% of patients receiving exenatide compared with 8% treated with just insulin glargine.


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