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news.Bristol-Myers Squibb has initiated ‘Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus’ trial (SAVOR-TIMI 53), to evaluate treatment with Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.
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Onglyza (saxagliptin) is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus.
SAVOR-TIMI 53 trial is a multicenter, randomised, double-blind, placebo-controlled Phase 4 study evaluating Onglyza. The five-year study will follow approximately 12,000 patients with type 2 diabetes, who have either a history of previous cardiovascular events or multiple risk factors for vascular disease, and includes patients with renal impairment.
Bristol-Myers Squibb said that the objectives of the SAVOR-TIMI 53 trial are to test the hypothesis of whether treatment with Onglyza compared with placebo when added to a patients’ current standard of care will result in a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke and to exclude an unacceptable cardiovascular toxicity.
The SAVOR-TIMI 53 trial was in part designed to fulfill a post-marketing requirement for the FDA, as well as to help answer the important question of potential benefit beyond glucose lowering. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Onglyza or any other antidiabetic drug.
Onglyza has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the US and EU. Onglyza was approved by the FDA in July 2009.
Eugene Braunwald, chairman of the TIMI Study Group, said: “One of the objectives of the SAVOR-TIMI 53 study is to test superiority of treatment with Onglyza versus placebo when added to current therapy, as well as exclude unacceptable cardiovascular risk.”