【摘 要】
：
In order to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk sponsors must consider the regulatory requiremen
【机 构】
：
Cardiovascular and Metabolic Therapeutic Delivery Unit Quintiles Transnational USA
【出 处】
：
BIT`s 2nd Annual World Congress of Endobolism-2012(2012第二届内分
论文部分内容阅读
In order to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk sponsors must consider the regulatory requirements outlined in both the January 2010,European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) draft guideline entitled Guideline on Clinical Investigation of Medicinal Products in the Treatment of Diabetes, as well as the FDA December 2008 Guidance for Industry entitled Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.Based on a review of the literature, as well as experience from designing and reviewing such programs-common critical decision points have been identified, and will be discussed: 1.MACE endpoints (primary and secondary)2.Estimating MACE event rate for population selected 3.Event rate implications of inclusion and exclusion criteria 4.Hazard Ratio implications 5.Study duration implications6.Interim analysis 7.Where to find suitable patients.
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