Redefining Hypoglycemia in Clinical Trials: Validation of Definitions Recently Adopted by the American Diabetes Association/European Association for the Study of Diabetes.
| Autor: | Heller SR; Academic Unit of Diabetes, Oncology & Metabolism, University of Sheffield, Sheffield, U.K. s.heller@sheffield.ac.uk., Buse JB; University of North Carolina School of Medicine, Chapel Hill, NC., Ratner R; Division of Endocrinology and Metabolism, Georgetown University Medical School, Washington, DC., Seaquist E; Department of Medicine, University of Minnesota, Minneapolis, MN., Bardtrum L; Novo Nordisk A/S, Søborg, Denmark., Hansen CT; Novo Nordisk A/S, Søborg, Denmark., Tutkunkardas D; Novo Nordisk A/S, Søborg, Denmark., Moses AC; Novo Nordisk Inc., Plainsboro, NJ. |
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| Jazyk: | angličtina |
| Zdroj: | Diabetes care [Diabetes Care] 2020 Feb; Vol. 43 (2), pp. 398-404. Date of Electronic Publication: 2019 Oct 28. |
| DOI: | 10.2337/dc18-2361 |
| Abstrakt: | Objective: To determine if the International Hypoglycaemia Study Group (IHSG) level 2 low glucose definition can identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials. Research Design and Methods: A post hoc analysis was performed of the SWITCH (SWITCH 1: n = 501, type 1 diabetes; SWITCH 2: n = 721, type 2 diabetes) and DEVOTE ( n = 7,637, type 2 diabetes) trials utilizing 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 (PG confirmed <3.0 mmol/L, independent of symptoms). Results: In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed. Similar results were observed for the SWITCH 1 trial. In SWITCH 2, the IHSG level 2 definition produced a rate ratio that was lower than the ADA 2005 definition. Conclusions: The IHSG level 2 definition was validated in a series of clinical trials, demonstrating its ability to discriminate between basal insulins. This definition is therefore recommended to be uniformly adopted by regulatory bodies and used in future clinical trials. (© 2019 by the American Diabetes Association.) |
| Databáze: | MEDLINE |
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