Assessing Cardiovascular Risk in Diabetes Drug Development
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC