Expanded Indication for Exenatide in Type 2 Diabetes

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On April 3, 2018, the U.S. Food and Drug Administration approved an expanded indication for exenatide extended-release (Bydureon®) for use as an add-on to basal insulin in adults with type 2 diabetes, inadequately controlled by one or more therapies (including metformin) along with diet and exercise.

This new indication is based on results from the DURATION-7 study (Guya et al, see reference below).  A 28-week trial comparing the efficacy of exenatide extended-release versus placebo as add-on therapy to insulin glargine, with or without metformin.  In that study, when exenatide extended-release was added insulin glargine, mean HbA1c was lowered by 0.9% versus 0.2% in placebo (p<0.001), without a significant increase in hypoglycemia risk.  Significantly more patients in the exenatide extended-release group than placebo patients reached their HbA1c target of <7% (32.5% vs 7.4%; P < .001), and exenatide patients had an average of 1.5 kg greater weight loss than placebo patients (p<0.001).

Once-weekly exenatide may be a valuable addition to the treatment of some adults with type 2 diabetes who are challenged to achieve control with basal insulin, oral medications and lifestyle changes.

Additional information about Exenatide can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.


Click here for press release on new FDA approval.

Guja C, Frías JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J.  Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study.  Diabetes Obes Metab.  2018 Feb 23. doi: 10.1111/dom.13266. [Epub ahead of print]

Lee C. Vermeulen

Professor of Medicine and Pharmacy, University of Kentucky