Clinical trials for diabetes medications aim to demonstrate efficacy and safety. The primary efficacy endpoint is typically a reduction in HbA1c (average blood glucose levels over 2-3 months), with a duration of at least 3 months. Safety monitoring focuses on hypoglycemia and other adverse events. Eligible patients generally have HbA1c between 6.5-11% and trial duration and control groups depend on the drug and intended patient population. Successful trials show comparable or superior efficacy to existing medications without increasing safety risks.

1. Clinical Trials for Diabetes Yeong-Liang Lin, MD, MS Center for Drug Evaluation