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.

Authors

David C Klonoff¹, Alexander Fleming², Robert Gabbay³

Affiliations

¹ Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.
² Kinexum, Harpers Ferry, WV, USA.
³ Joslin Diabetes Center, One Joslin Place, Boston, MA, USA.

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