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GUIDANCE DOCUMENT

Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products May 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-0625

Docket Number:
FDA-2023-D-0625
Issued by:
Guidance Issuing Office
Center 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.

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