The University Group Diabetes Program (UGDP) was a multicenter, investigatorinitiated, trial started in 1960 and finished two decades later designed to assess the value of established antihyperglycemic drugs for prevention of the late complications of adult-onset diabetes. The trial has historical importance in that it was one of the first multicenter long-term prevention trials designed to assess the safety and efficacy of established treatments. This chapter provides a chronology of the trial and account of the legal battle mounted by the Committee for the Care of the Diabetic (CCD) to forestall the label change proposed by the FDA regarding the possibility of cardiovascular (CV) risks associated with tolbutamide. It also provides a list of criticisms leveled against the trial and responses to those criticisms.
- Cardiovascular (CV) risks
- University Group Diabetes Program (UGDP)
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