Byetta (exenatide) injection has been approved by the FDA 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. 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, M.D., Ph.D., 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 as well as aggressive insulin titration. Those at risk of hypoglycemia had a 20% lower Byetta dose.
After 30 weeks:
- Those in the Byetta group achieved A1C decrease of 1.7 percentage points
- 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."
The Byetta trial was published in Annals of Internal Medicine.
DiabetesApproximately 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).
The vast majority of diabetes type two patients are overweight, and 55% are estimated to be obese. Studies have demonstrated that weight loss, even moderate amounts, can help patients achieve and sustain glycemic control.
Byetta (exenatide) injectionAccording to Amylin Pharmaceuticals and Eli Lilly and Company, the manufacturers of the drug, exenatide was the first GLP-1 (glucagon-like peptide) receptor agonist the FDA approved for diabetes type 2 treatment. Its effects are similar to the GLP-1 (a human incretin hormone), which improves blood glucose after eating "through multiple effects that work in concert on the stomach, liver, pancreas and brain".
Exenatide's chemical formula is C184H282N50O60S.
Byetta is administered by subcutaneous injection (under the skin). When used with an exercise program and diet it can help improve blood glucose (sugar) in adults with type 2 diabetes. It can also be used with metformin.
Byetta should not be used as a replacement for insulin - it is not insulin. Neither should it be taken with short- and/or rapid-acting insulin. The drug is not suitable for those with diabetes type 1 or individuals with diabetic ketoacidosis. No studies have been carried out regarding Byetta usage on patients with a history of pancreatitis.
Byetta provides potential weight loss and sustained A1C control. The manufacturers emphasize that it is not a weight-loss medication.
Written by Christian Nordqvist