Guidance for Industry. Diabetes Mellitus? Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Dec 2008.
Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus. European Medicines Agency (January 2010).