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US FDA grants approval to use BYETTA with insulin glargine

  The US Food and Drug Administration (FDA) has approved the use of BYETTA (exenatide) injection by Amylin Pharmaceuticals, as an add-on therapy to insulin glargine for adults with type 2 diabetes.

BYETTA is a glucagon-like peptide-1 (GLP-1) receptor agonist which shows similar effects as the human incretin hormone GLP-1, according to Eli Lilly and Company .

A study conducted to evaluate the efficacy of the product demonstrated that patients who received BYETTA in addition to insulin glargine showed better reduction in A1C (a measure of average blood sugar over three months) as compared to those treated with insulin glargine alone.

The primary endpoint was reduction in A1C and the secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.