1. Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine.
- Author
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Simonson DC, Testa MA, Ekholm E, Su M, Vilsbøll T, Jabbour SA, and Lind M
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Hypoglycemia chemically induced, Hypoglycemia epidemiology, Treatment Outcome, Adult, Patient Reported Outcome Measures, Continuous Glucose Monitoring, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 blood, Insulin Glargine therapeutic use, Insulin Glargine administration & dosage, Benzhydryl Compounds therapeutic use, Benzhydryl Compounds adverse effects, Benzhydryl Compounds administration & dosage, Adamantane analogs & derivatives, Adamantane therapeutic use, Adamantane administration & dosage, Adamantane adverse effects, Glucosides therapeutic use, Glucosides adverse effects, Glucosides administration & dosage, Dipeptides therapeutic use, Dipeptides adverse effects, Blood Glucose analysis, Blood Glucose drug effects, Glycated Hemoglobin analysis, Drug Therapy, Combination, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Blood Glucose Self-Monitoring
- Abstract
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.)
- Published
- 2024
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