Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine.
Publication/Presentation Date
11-18-2024
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.
Volume
109
Issue
12
First Page
2261
Last Page
2261
ISSN
1945-7197
Published In/Presented At
Simonson, D. C., Testa, M. A., Ekholm, E., Su, M., Vilsbøll, T., Jabbour, S. A., & Lind, M. (2024). Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine. The Journal of clinical endocrinology and metabolism, 109(12), e2261–e2272. https://doi.org/10.1210/clinem/dgae105
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
38412282
Department(s)
Administration and Leadership
Document Type
Article