Clinical trials to support registration of new drugs are arduous, lengthy, and 
expensive. Diabetes treatment trials intended to seek indications for glycemic 
control are facilitated by the regulatory acceptance of glycosylated hemoglobin 
(A1C) as a validated intermediate efficacy end point. However, A1C outcomes are 
not meaningful when taken outside of the context of hypoglycemia risks. Current 
regulatory guidance indicates that A1C efficacy end points and hypoglycemia 
safety end points be considered separately. A composite end point for diabetes 
treatment trials that integrates A1C and hypoglycemia risk into a single measure 
is proposed. An example would be "percentage of patients achieving A1C <7% 
without unacceptable hypoglycemia." The benefits and limitations of such an 
approach are discussed.