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Diabetes Drug Saxagliptin (Onglyza) Fails to Meet Efficacy Endpoint in Key Study

Treatment no more effective than placebo (June 19)

Disappointing results have been reported from a phase IV trial of saxagliptin (Onglyza, AstraZeneca/Bristol-Myers Squibb) in adult patients with type 2 diabetes.

The SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus) trial involved 16,500 diabetic patients with either a history of established cardiovascular disease or multiple risk factors.

Saxagliptin met the study’s primary safety objective of non-inferiority versus placebo, but it did not meet the primary efficacy objective of superiority over placebo for a composite endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke when added to a patient’s current standard of care (with or without other antidiabetic therapies).

The study results will be submitted to the European Society of Cardiology (ESC) for possible presentation at the ESC Congress in September.

Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

According to Reuters, sales of the drug have recently stalled in the U.S.

Sources: AstraZeneca; June 19, 2013; and Reuters; June 19, 2013.

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