FDA On Track to Update Diabetes Efficacy Endpoints Guidance


This latest guidance provides a 15-year update on the recommendations, including the use of CGM devices.

Last week, FDA issued a draft guidance for industry titled “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.” This draft guidance provides a 15-year update to the FDA’s previous recommendations on efficacy endpoints for such products.

“Diabetes is a common disease that affects nearly 40 million people in the U.S. and is projected to affect more in the coming years. The need for more antidiabetic treatment options is clear,” said Lisa Yanoff, M.D., deputy director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Today’s draft guidance demonstrates the FDA’s ongoing commitment to providing industry with up-to-date recommendations on how to approach developing new drug therapies.”

The draft guidance outlines the FDA’s general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes. Topics covered in the draft guidance include:

  • Hemoglobin A1c (A1C), a measure of average blood sugar, remaining an acceptable primary efficacy endpoint
  • The FDA now considering a reduction in the risk of hypoglycemia (low blood sugar) to be a clinically relevant outcome measure for diabetes drug clinical trials, when accompanied by either a reduction or maintenance of an acceptable A1C.
  • The use of data collected by continuous glucose monitoring (CGM) systems, which allow for nonstop, passive glucose monitoring, in clinical trials to potentially support hypoglycemia labeling claims. Recent advancements in CGM technology have led the agency to recognize the advantages of data collected from these systems in clinical drug development.

The FDA will be accepting comments on the guidance until August 24, 2023.

Reference: FDA Roundup: May 26, 2023

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