The Need to Change Regulatory Evaluation of Hypoglycemia in Trials of Diabetes Treatments

J Diabetes Sci Technol. 2020 Nov;14(6):987-989. doi: 10.1177/1932296819891036. Epub 2019 Nov 19.
No abstract available

Keywords: FDA; clinical trial; diabetes; drug; hypoglycemia.

Publication types

  • Editorial

MeSH terms

  • Biomarkers / blood
  • Blood Glucose / drug effects*
  • Blood Glucose / metabolism
  • Clinical Trials as Topic*
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / diagnosis
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Endpoint Determination
  • Glycemic Control / adverse effects*
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / chemically induced
  • Hypoglycemia / diagnosis
  • Hypoglycemia / prevention & control*
  • Hypoglycemic Agents / adverse effects*
  • Research Design*
  • Risk Assessment
  • Risk Factors
  • Treatment Outcome

Substances

  • Biomarkers
  • Blood Glucose
  • Hypoglycemic Agents