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FDA approves exenatide for use with basal insulin in type 2 diabetes
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The FDA approved an expanded indication for the GLP-1 receptor agonist exenatide extended, allowing for its use as an add-on therapy with basal insulin in people with poorly controlled type 2 diabetes, Astra Zeneca announced in a press release.
Exenatide (Bydureon), a once-weekly injectable, is approved for adults with type 2 diabetes whose blood glucose remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control. The drug is intended to help the body produce more insulin in response to an increase in glucose, reduce glucagon production and slow gastric emptying, to assist in reducing hyperglycemia.
“Type 2 diabetes is a complex disease for patients and health care providers to manage, which is why we continue to invest in the advancement of science supporting the safety and efficacy of exenatide, even 13 years after the first exenatide formulation was introduced to the market,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes at AstraZeneca, said in a statement. “The DURATION-7 study is part of the broader DURATION clinical trial program which continues to yield vital insights on the use of exenatide. The Bydureon clinical program is one of the most extensive clinical trial programs of a GLP-1 receptor agonist to date, having been studied in more than 19,000 patients. With this approval, we are providing another important treatment option for health care providers to consider for patients with type 2 diabetes on basal insulin with inadequate glycemic control.”
The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of exenatide or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with type 2 diabetes. Patients assigned exenatide therapy (n = 231) experienced a mean HbA1c decrease of 0.9% compared with a mean 0.2% HbA1c reduction for those assigned placebo (n=229; between-group difference, 0.6%; P < .001). In addition, 32.5% of patients in the exenatide group reached an HbA1c of less than 7% vs. 7% of patients in the placebo group (mean baseline HbA1c, 8.5%).
There were no between-group differences in hypoglycemia incidence (exenatide, 29.7% and placebo, 29%), with no reported major hypoglycemia. In both arms, the same percentage of patients reported minor hypoglycemia (5.6%). Like other GLP-1 receptor agonists, the risk of hypoglycemia is increased when exenatide is co-administered with insulin, and prescribers should consider lowering the dose of insulin when co-administering exenatide, Astra Zeneca noted in the release.
The most common adverse events noted in clinical trials were nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%).
Exenatide was first approved by the FDA in January 2012.