Assessing Cardiovascular Risk in Diabetes Drug Development
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*David H Manner, Eli Lilly and Company 

Keywords: Diabetes, Cardiovascular Risk, meta-analysis

The final guidance document "Diabetes Mellitus: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" issued by the FDA in December 2008 provided recommendations to sponsors on how to evaluate cardiovascular risk for a new antidiabetic therapy for treatment of type 2 diabetes. Specifically, this document describes the need for meta-analyses of cardiovascular endpoints in phase 2 and phase 3 clinical trials and for the possible need of a large cardiovascular outcomes study. We will describe approaches to the design of the phase 2 and 3 studies to allow for a meta-analysis of this data and how the meta-analysis can be conducted. We will also describe the large cardiovascular outcomes study design and analyses resulting from this study to meet FDA guidance thresholds around cardiovascular risk.