Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products May 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to help sponsors develop antidiabetic drugs for adults and children with type 1 diabetes mellitus (T1D) and/or type 2 diabetes mellitus (T2D). In this guidance, antidiabetic drugs refer to drugs intended to improve glycemic control, including drugs intended to reduce diabetes-related hyperglycemia (i.e., antihyperglycemic drugs) and drugs intended to mitigate iatrogenic hypoglycemia associated with diabetes management.