Five-year cardiovascular study planned for Onglyza
pharmafile | March 10, 2010 | News story | Research and Development, Sales and Marketing | DPP-4, Onglyza, diabetes
Bristol-Myers Squibb and AstraZeneca are to embark on a five-year study of Onglyza in type II diabetes patients who may be prone to cardiovascular problems.
In part, SAVOR-TIMI 53 has been designed to fulfill a post-marketing requirement for US regulator the FDA.
But it will also look at whether there is any benefit to taking Onglyza beyond glucose lowering – macrovascular risk reduction has not yet been proved with any antidiabetic drug.
“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,” said Eugene Braunwald, chairman of the TIMI study group.
The idea of the phase IV trial is also to exclude unacceptable cardiovascular risk, he added.
SAVOR-TIMI 53 will encompass 12,000 patients with either a history of previous cardiovascular events or multiple risk factors for vascular disease.
It also includes patients with renal impairment, who can be given a daily 2.5mg dose, following haemodialysis.
Investigators expect to find out whether Onglyza, added to 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 compared to placebo.
Braunwald plus TIMI senior investigator Deepak Bhatt and Itamar Raz, head of the diabetes unit at the Hadassah University Medical Center in Jerusalem, will conduct the trial.
Onglyza (saxagliptin) was launched in the UK last year and can be combined with metformin, a sulphonylurea or a thiazolidinedione when those drugs, plus diet and exercise, have not worked sufficiently.
Like MSD’s Januvia (sitagliptin) and Novartis’ Galvus (vildagliptin), Onglyza is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which works by preventing the breakdown of incretins, released after food, and by increasing the bodys utilisation of glucose.
In trials the drug improved glycaemic control, with no increased risk of weight gain and hypoglycaemic episodes.
Onglyza has so far been approved in 38 countries, including the US and European Union.
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