TY - JOUR

T1 - Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine

AU - Simonson, Donald C

AU - Testa, Marcia A

AU - Ekholm, Ella

AU - Su, Maxwell

AU - Vilsbøll, Tina

AU - Jabbour, Serge A

AU - Lind, Marcus

PY - 2024

Y1 - 2024

N2 - ContextGlycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies.ObjectiveWe 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).Design24-week substudy of a randomized, open-label, 2-arm, parallel-group, phase 3b study.SettingMulticenter study (112 centers in 11 countries).Patients283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea.InterventionsDAPA + SAXA vs INS.Main outcome measuresChanges in CGM profiles, HbA1c, and PROs.ResultsChanges 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.ConclusionDAPA + 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 tim

AB - ContextGlycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies.ObjectiveWe 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).Design24-week substudy of a randomized, open-label, 2-arm, parallel-group, phase 3b study.SettingMulticenter study (112 centers in 11 countries).Patients283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea.InterventionsDAPA + SAXA vs INS.Main outcome measuresChanges in CGM profiles, HbA1c, and PROs.ResultsChanges 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.ConclusionDAPA + 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 tim

U2 - 10.1210/clinem/dgae105

DO - 10.1210/clinem/dgae105

M3 - Journal article

C2 - 38412282

SP - 1

EP - 12

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

SN - 0021-972X

ER -