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.
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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.
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The double-blind clinical trial evaluating Byetta as an add-on therapy to Lantus was published in Annals of Internal Medicine
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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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