Byetta Can Now Officially Be Used With Lantus

written by Michael O'Leary

Adult type 2 diabetes patients who use insulin have a new option for controlling their blood glucose.

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company announced Oct. 19, that the FDA has approved a new use for BYETTA® (exenatide) injection. The drug can now be used by those using the insulin glargine (Lantus®) with or without metformin and or thiazolidinedione and still haven’t achieved control of their blood sugar.

Dr. Christian Weyer, senior vice president, research and development at Amylin said this marks an important new option for the 60 percent of type 2 diabetes patients who haven’t been able to reach their target blood sugar levels. (Link to published site)

“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,” Weyer said in a press release. “This complementary approach to glycemic control will further extend the use of BYETTA across the continuum of type 2 diabetes care.”

In the study the FDA based its approval, 261 patients receiving insulin glargine with or without metformin and/or a thiazolidinedione were randomly assigned to receive BYETTA or placebo. After 30 weeks of treatment, 60 percent the BYETTA participants achieved the target blood glucose or HbA1c level of less than or equal to 7 percent compared to 35 percent of the insulin glargine alone group. Similarly 40 percent of the BYETTA group reached an HbA1c target of 6.5 percent or less compared to 12 percent for the insulin alone group.

On the downside, nausea, which was the most common adverse event, occurring in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin glargine alone. Thirteen BYETTA recipients (9 percent) and one placebo recipient (1 percent) discontinued the study because of adverse side effects.

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus when used with a diet and exercise program. It can also be used with metformin, a sulfonylurea, a thiazolidinedione and now with Lantus® (insulin glargine), which is a long-acting insulin.

BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

According to the Centers for Disease Control and Prevention, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen. In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese. Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.

BYETTA has been shown in earlier trials to help people with type 2 diabetes both control their blood glucose levels and lose weight.