FDA approves Byetta as insulin glargine add-on

The FDA has expanded indications for the type 2 diabetes drug exenatide (Byetta) for use in conjunction with insulin glargine, diet and exercise in adult patients.

The drug is the first GLP-1 receptor agonist available for use as an adjunct to insulin glargine, with or without metformin or a thiazolidinedione, to achieve glycemic control, according to a statement from manufacturers Amylin Pharmaceuticals and Eli Lilly.

“This expanded use for exenatide 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,” John Buse, MD, PhD, professor of medicine and director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of medicine in Chapel Hill, said in a press release.

Data from two clinical trials support the expanded indication. In one, glycated hemoglobin (HbA1c) levels were compared in patients treated with exenatide and insulin glargine versus those treated with insulin glargine alone. Patients in the dual-treatment group had a 1.7 percentage-point decrease in HbA1c levels, versus a 1 percentage-point drop in the insulin-alone group (P<0.001).

In second study, 261 patients treated with insulin glargine with or without metformin or a thiazolidinedione were randomly assigned to exenatide or placebo as an adjunctive treatment. Study endpoints included reduction in HbA1c, change in body weight, and other parameters related to glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.

After 30 weeks, significantly more patients in the exenatide group reached the target of HbA1c ≤7% than in the placebo group (60% vs. 35%; P<0.001). In addition, 40% of patients in the drug treatment group reached HbA1c levels ≤6.5% compared with 12% in the placebo group.

Although both groups had lower fasting plasma glucose concentrations, patients taking exenatide experienced significant improvements in postprandial glucose control after morning and evening meals compared with placebo. 

Body weight decreased an average of 4 lbs. among patients taking exenatide vs. an average 2 lb. increase in those treated with insulin glargine alone.

Hypoglycemia rates were similar in both treatment groups. Patients taking exenatide experienced adverse events such as nausea, diarrhea, vomiting, headache and constipation more frequently than the placebo group.

Exenatide has also been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, so clinicians should monitor patients who begin taking the drug or who have their dose escalated for pancreatitis signs and symptoms.

Patients with severe kidney problems or who have received a kidney transplant should avoid taking exenatide, the manufacturers said, and those with severe stomach problems, including gastroparesis, should consult a healthcare professional before starting therapy.

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