BioSpace reports that the United States Food and Drug Administration (U.S FDA) has approved a new indication for exenatide (Byetta®) injection. The licence extension covers use of the drug as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycaemic control on insulin glargine alone.

The approval is based on a study in which patients with type 2 diabetes (n=261) receiving insulin glargine, with or without metformin and/or a TZD, were randomised to receive exenatide or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, HbA1C decreased by 1.7 percentage points in patients adding exenatide, compared with a decrease of 1.0 percentage point in patients treated with insulin glargine alone (p<0.001). With respect to adverse events, nausea was the most common and occurred in 41 % of patients treated with exenatide compared with 8 % of patients treated with insulin glargine alone. Thirteen patients on exenatide and one placebo recipient (9 percent vs. 1 percent) discontinued the study because of adverse events (p<0.010). 

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