Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions

In February 2018, a think tank comprising representatives from academia, industry, and regulatory agencies convened to consider the guidance to pharma on conducting trials of glucose-lowering therapies in light of the findings of the completed CV outcome trials.

SPS commentary:

New recommendations from think tank include requiring only the 1.3 non-inferiority margin for regulatory approval, conducting trials for longer durations, considering studying glucose-lowering therapies as first-line management of type 2 diabetes, considering heart failure or kidney outcomes within the primary outcome, considering head-to-head active comparator trials, increasing the diversity of patients enrolled, evaluating strategies to streamline registries and the study of unselected populations, and identifying ways to improve translation of trial results to general practice.