BMS and AZ start phase IV diabetes trial

Bristol-Myers Squibb (BMS) and AstraZeneca (AZ) have launched a five-year post-marketing study to evaluate Onglyza (saxagliptin) in patients with diabetes mellitus.

The "Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus" trial (SAVOR-TIMI 53) is a multi-centre, randomised, double-blind, placebo-controlled phase IV study to evaluate treatment with Onglyza, a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.

The study will follow approximately 12,000 patients with type 2 diabetes with history of previous cardiovascular events or multiple risk factors for vascular disease. It includes patients with renal impairment.

It aims to test whether treatment with Onglyza compared with placebo when added to current care results in a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke and to exclude unacceptable cardiovascular toxicity.

The SAVOR-TIMI 53 trial fulfils a post-marketing requirement of the US Food and Drug Administration, as well as investigating any potential benefits beyond glucose lowering.

Drs Eugene Braunwald and Deepak L Bhatt, of the TIMI Study Group, and Dr Itamar Raz, head of the diabetes unit at Hadassah University Medical Centre, Jerusalem, are the principal investigators conducting the trial for B-MS and AZ. BMS and AZ started collaborating on drugs for type 2 diabetes in January 2007.

Onglyza has been submitted for regulatory review in more than 50 countries and is approved in 38.