FDA Approves Byetta for Use with Lantus Insulin in the U.S.

October 20, 2011

The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly’s type 2 diabetes drug, Byetta (exenatide) injection.  Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone. The FDA approved Byetta as an add-on therapy to Lantus following a clinical trial where patients using Byetta with insulin glargine achieved better glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using Lantus alone.
In the study supporting the expanded use, patients receiving Lantus, with or without metformin and/or a TZD, were randomized to receive Byetta or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1c, a measure of average blood sugar over three months, decreased by 1.7 percentage points in patients adding Byetta, compared with a decrease of 1.0 percentage point in patients treated with Lantus alone (p<0.001). Nausea, which was the most common adverse event, occurred in 41 percent of patients treated with Byetta compared with 8 percent of patients treated with Lantus alone.  On average, weight decreased by 4 pounds in patients adding Byetta, compared with an increase of 2 pounds in patients treated with Lantus alone (p<0.001). The greater improvement in A1c with Byetta was not accompanied by an increase in hypoglycemia, compared to Lantus alone.
The double-blind clinical trial evaluating Byetta as an add-on therapy to Lantus was published in Annals of Internal Medicine
Byetta was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction.

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