Redefining hypoglycemia in clinical trials: validation of definitions recently adopted by the American Diabetes Association/European Association for the study of diabetes

Autor: Heller, S.R., Buse, J.B., Ratner, R., Seaquist, E., Bardtrum, L., Hansen, C.T., Tutkunkardas, D., Moses, A.C.
Jazyk: angličtina
Rok vydání: 2020
ISSN: 0149-5992
Popis: OBJECTIVE The purpose of this study was to determine if the International Hypoglycemia Study Group (IHSG) level 2 low glucose definition could identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials.\ud \ud RESEARCH DESIGN AND METHODS A post hoc analysis of the SWITCH (SWITCH 1: n = 501, type 1 diabetes; SWITCH 2: n = 721, type 2 diabetes) and the Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE; n = 7,637, type 2 diabetes) using the IHSG low glucose definitions. Patients in all trials were randomized to either insulin degludec or insulin glargine 100 units/mL. In the main analysis, the following definitions were compared: 1) American Diabetes Association (ADA) 2005 (plasma glucose [PG] confirmed ≤3.9 mmol/L with symptoms); and 2) IHSG level 2 (glucose confirmed
Databáze: OpenAIRE