Byetta combination with insulin glargine gets FDA nod in type 2 diabetes

By Dr. Ananya Mandal, MDOct 20 2011

The US Food and Drugs Administration (FDA) has approved Byetta (exenatide) injection as add-on treatment for use with insulin glargine, together with exercise and diet for diabetes type 2 patients who are not responding well enough to glargine alone. Byetta's add-on therapy is for those on glargine with metformin and/or a TZD (thiazolidinedione) or without.

This approval came after a pivotal study found that with exenatide patients achieved better glycemic control without gaining weight or increased hypoglycemia risk, compared to those on just glargine.

John Buse, professor of medicine, 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, “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. 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.”

In the double-blind clinical trial involving 261 patients, those receiving insulin glargine (with or without metformin and/or a TZD) were randomly selected to be given Byetta (10 micrograms) or placebo or dummy as well as aggressive insulin titration. Those at risk of hypoglycemia had a 20% lower Byetta dose. The Byetta trial was published in Annals of Internal Medicine.

After the study period of 30 weeks those in the Byetta group achieved A1C decrease of 1.7 percentage points. A1C or glycosylated hemoglobin is a marker for long term (three month) blood sugar control in diabetics. Those on just insulin glargine achieved A1C decrease of 1 percentage point.

The most common adverse event was nausea, which affected 41% of those in the Byetta group, versus 8% in the other group.

Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals, said, “Since 2005, when Byetta was approved as the first-in-class GLP-1 receptor agonist, we have continued to investigate its usefulness for patients across the broad spectrum of type 2 diabetes. With this approval, Byetta is now the first and only GLP-1 receptor agonist approved for use in the U.S. as an adjunct to insulin glargine, 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.”

Approximately 347 million adults are thought to be affected by diabetes, of which 26 million are Americans. Between 90% and 95% of them have diabetes type 2. The annual health bill for direct and indirect medical expenses in the USA from diabetes is $174 billion. About 6 in every 10 diabetes patients do not achieve their target blood glucose levels with their current treatments, says the CDC (Center for Disease Control and Prevention).