AstraZeneca diabetes trial meets safety objective

AstraZeneca said on Tuesday that its Bydureon EXSCEL trial met its primary safety objective in type 2 diabetes patients at a wide range of cardiovascular risk.

The trial compared the effect of once-weekly Bydureon versus a placebo, when added to usual type-2 diabetes care, on the risk of major adverse cardiovascular events, a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, in adults with type-2 diabetes at a wide range of CV risk.

The trial addresses a US Food and Drug Administration requirement that medicines to treat type 2 diabetes not be associated with increased CV risk. Although fewer CV events were observed in the Bydureon arm, Astra said the reduction in CV risk was not statistically significant.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: "These top-line results from the EXSCEL trial provide robust evidence of the cardiovascular safety profile of Bydureon across a wide range of patients with type-2 diabetes. Furthermore, the trial design and broad inclusion criteria of EXSCEL offer physicians relevant data applicable to clinical practice."

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