FDA approves exenatide for use with insulin glargine
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.”