Byetta Gains Indication as Add-On Therapy to Insulin Glargine

Amylin and Lilly announced that Byetta (exenatide injection) has gained an indication for use as 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 glycemic control on insulin glargine alone.

This approval was based on data from a double-blind study in which 261 patients receiving insulin glargine, 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 decreased by 1.7 percentage points in patients adding Byetta, compared with a decrease of 1 percentage point in patients treated with insulin glargine alone (P<0.001). The proportion of patients achieving the target A1C ≤7% was 60% in the Byetta group and 35% in the insulin glargine group (P<0.001). For the target A1C ≤6.5%, the proportions were 40% and 12%, respectively (P<0.001).

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