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Cardiovascular Safety Studies With DPP-4 Inhibitors The Clinical Guidance for Pharmaceutical IndustryDiabetes MellitusEvaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes established by the FDA in 2008 as a consequence of adverse safety signals of rosiglitazone has set up the requirement for novel diabetes medications to prove cardiovascular safety of these substances in comparison to standard therapy under glycaemic equipoise

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doi:10.1210/en.2012-1937 Jin T, Weng J

Moreover, differences in outcome reporting, such as the use of absolute versus relative changes, or inconsistent definitions of endpoints like visceral adiposity or insulin resistance, further limited the ability to standardize data extraction and synthesis