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FDA approves exenatide for use with insulin glargine

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The FDA has approved the use of exenatide as an add-on therapy to insulin glargine, with or without metformin or thiazolidinedione, in conjunction with diet and exercise for adults with type 2 diabetes, according to a press release.

“Since 2005, when Byetta (exenatide; Amylin, Eli Lilly) was approved as the first-in-class [glucagon-like peptide 1] receptor agonist, we have continued to investigate its usefulness for patients across the broad spectrum of type 2 diabetes,” Christian Weyer, MD, senior vice president of research and development at Amylin, said in the release. “With this approval, Byetta is now the first and only GLP-1 receptor agonist approved for use in the US as an adjunct to insulin glargine (Lantus, Sanofi-Aventis) with or without certain oral agents. This complementary approach to glycemic control will further extend the use of Byetta across the continuum of type 2 diabetes care.”

In a study examining the expanded use of exenatide, 261 patients receiving insulin glargine, with or without metformin or a TZD, were randomly assigned to receive 10 mcg of exenatide or placebo, and patients with a HbA1c level of 8% or less reduced their insulin glargine dose by 20%. After 5 weeks, all patients underwent aggressive insulin titration to target fasting blood glucose.

At 30 weeks, 60% of patients in the exenatide group vs. 35% in the insulin glargine-only group achieved a target HbA1c level of 7% or less (P<.001). Further, 40% of patients using exenatide vs. 12% of patients using insulin glargine-alone achieved a target HbA1c of 6.5% or less. All patients had lower fasting plasma glucose concentrations, although patients receiving exenatide had improved postprandial glucose control compared with patients in the placebo group. Patients in the exenatide arm also lost an average of 4 lb, whereas patients in the insulin glargine-only arm gained 2 lb (P<.001). No increased risk for hypoglycemia was noted in the exenatide group, and nausea was the most commonly reported adverse event.

“This expanded use for Byetta is important for clinical care in that it provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals,” said John Buse, MD, PhD, professor of medicine, director of the Diabetes Care Center and endocrinology chief at the University of North Carolina School of Medicine in Chapel Hill. “Byetta is well-suited for use with insulin glargine, offering a simple, fixed-dose regimen that can help improve control of blood sugar overall and after meals. In a clinical trial, patients using Byetta with insulin glargine achieved better glycemic control without weight gain or an increased risk of hypoglycemia compared to patients using insulin glargine alone.”

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