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# Changes Sought in FDA Diabetes Endpoint Guidance
- URL: https://www.fdaweb.com/changes-sought-in-fda-diabetes-endpoint-guidance/
- Published: 2023-08-23T12:00:00.000Z
- Updated: 2026-09-14T18:52:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155166

AstraZeneca says an FDA draft guidance on efficacy endpoints for clinical trials investigating antidiabetic drugs and biological products, when combined with a 2020 guidance, appears to cover substantially less material than the 2008 guidance it replaces. In a comment [letter](https://www.regulations.gov/comment/FDA-2023-D-0625-0008?ref=fdaweb.com), the company suggests that the agency consider including in the new draft a reference to where sponsors can find guidance on pharmacokinetic/pharmacodynamic considerations, weight loss, metabolic syndrome, important statistical considerations, randomized withdrawal, and guidance on fixed-dose combinations and other topics that are not covered.

In its [response](https://www.regulations.gov/comment/FDA-2023-D-0625-0009?ref=fdaweb.com), Pfizer says that hypoglycemia prevention is an important element of diabetes management in pediatric patients and thus the number and severity of hypoglycemia events are important endpoints of disease management and the assessment of treatment option efficacy. “We suggest including hypoglycemic level 1 as an acceptable endpoint for young pediatric patients,” it says.

Sanofi [submitted](https://www.regulations.gov/comment/FDA-2023-D-0625-0011?ref=fdaweb.com) line-by-line technical comments.