Byetta Approved as Lantus Add-On

On October 19, the US Food and Drug Administration (FDA) approved the Type 2 diabetes medicine Byetta (exenatide) as an add-on treatment to Lantus (insulin glargine) in people who have not achieved blood glucose control with Lantus, diet, and exercise alone.

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Byetta belongs to a class of drugs known as incretin mimetics, which duplicate the action of a hormone known as incretin. Medicines in this class work by stimulating insulin secretion, suppressing glucagon (a hormone that signals the liver to release glucose when blood glucose levels drop) secretion, and slowing stomach emptying. Lantus is a long-acting basal, or background, insulin, which works to reduce blood glucose levels in the body for about 24 hours.

The combination of Byetta and Lantus is approved in adults with Type 2 diabetes with or without metformin or a thiazolidinedione such as Actos.

Support for the combination use of these medicines was demonstrated in a study involving 261 people with Type 2 diabetes being treated with Lantus, with or without metformin or a thiazolidinedione. Participants were randomly assigned to received either Byetta in addition to their treatment regimen or a placebo (inactive treatment).

Those receiving Byetta experienced, on average, a 1.7% drop in their HbA1c (a marker of blood glucose control) compared to a 1% drop in the placebo group. This larger improvement in HbA1c was not associated with any increased risk of low blood glucose. Furthermore, 60% of people in the Byetta group achieved and HbA1c level less than or equal to 7% after 30 days, compared to only 35% of those in the placebo group. After-meal blood glucose control was also significantly better in the Byetta group after morning and evening meals compared to the placebo group.

Byetta should not be taken in combination with short- or rapid-acting insulins. People with severe kidney problems or those who have received a kidney transplant should not take this medicine. The most common side effects of Byetta include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness.

For more information about the approval, see the press release on Eli Lilly’s Web site.

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