Thursday, April 18, 2013

The first outcome study on a DPP-IV inhibitor will report data Mid year 2013

The SAVOR study is a placebo-controlled 16,500 patient trial designed to evaluate the safety and efficacy of saxagliptin (Onglyza) with regard to cardiovascular outcomes in diabetic patients (A1c 6.5 – 12) either with a previous cardiovascular event or at high risk for cardiovascular events.  The study is expected to report top line data by mid year 2013.   

The data from the study will be crucial as the implications are likely to be across the DPP-IV class. Currently the DPP-IV take about 12 percent share in the the oral diabetes marketIf Onglyza is able to show a reduction in CV outcome, this would not only help Onglyza enhance its market share within the DPP-IV space, but also help the DPP-IV class in further increasing its dominance in the overall oral anti-diabetes market.
The data from the study is also awaited as it would also provide signals on the long term safety of the DPP-IV class, especially with regard to the pancreatitis issue.

SAVOR is an event driven trial designed to stop when 1040 primary endpoint events are collected. The primary efficacy and safety endpoint is the time to the first occurrence of the  composite of CV death, non-fatal MI or non-fatal ischemic stroke. Subjects can be treated with glucose lowering medications including oral antidiabetics and/or insulin but excluding incretin based therapy. Subjects not being treated with anti-diabetic medication at baseline are also being enrolled. 
  1. Top-line data expected in mid-2013.
  2. Study lead by the academic research organizations TIMI Study Group and Hadassah University Medical Center.

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