Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine.

Autor:	Simonson DC; Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA., Testa MA; Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA 02115, USA.; Department of Research and Development, Phase V Technologies, Inc., Wellesley Hills, MA 02481, USA., Ekholm E; Division of Cardiovascular, Renal and Metabolism (CVRM), AstraZeneca R&D, 431 83 Gothenburg, Sweden., Su M; Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA 02115, USA.; Department of Research and Development, Phase V Technologies, Inc., Wellesley Hills, MA 02481, USA., Vilsbøll T; Clinical Research, Steno Diabetes Center Copenhagen, 2730 Herlev, Denmark.; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark., Jabbour SA; Division of Endocrinology, Diabetes & Metabolic Diseases, Thomas Jefferson University, Philadelphia, PA 19107, USA., Lind M; Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, 405 30 Gothenburg, Sweden.; Department of Medicine, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden.; Department of Medicine, NU-Hospital Group, 461 85 Trollhättan and 451 80 Uddevalla, Sweden.
Jazyk:	angličtina
Zdroj:	The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2024 Nov 18; Vol. 109 (12), pp. e2261-e2272.
DOI:	10.1210/clinem/dgae105
Abstrakt:	Context: Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. Objective: We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA + SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). Design: 24-week substudy of a randomized, open-label, 2-arm, parallel-group, phase 3b study. Setting: Multicenter study (112 centers in 11 countries). Patients: 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. Interventions: DAPA + SAXA vs INS. Main Outcome Measures: Changes in CGM profiles, HbA1c, and PROs. Results: Changes from baseline in HbA1c with DAPA + SAXA were similar to those observed with INS, with mean difference [95% confidence interval] between decreases of -0.12% [-0.37 to 0.12%], P = .33. CGM analytics were more favorable for DAPA + SAXA, including greater percent time in range (> 3.9 and ≤ 10 mmol/L; 34.3 ± 1.9 vs 28.5 ± 1.9%, P = .033), lower percent time with nocturnal hypoglycemia (area under the curve ≤ 3.9 mmol/L; 0.6 ± 0.5 vs 2.7 ± 0.5%, P = .007), and smaller mean amplitude of glycemic excursions (-0.7 ± 0.1 vs -0.3 ± 0.1 mmol/L, P = .017). Improvements in CGM were associated with greater satisfaction, better body weight image, less weight interference, and improved mental and emotional well-being. Conclusion: DAPA + SAXA and INS were equally effective in reducing HbA1c at 24 weeks, but people with T2D treated with DAPA + SAXA achieved greater time in range, greater reductions in glycemic excursions and variability, less time with hypoglycemia, and improved patient-reported health outcomes. (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
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