Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA 02115, USA.
J Clin Endocrinol Metab. 2024 Nov 18;109(12):e2261-e2272. doi: 10.1210/clinem/dgae105.
Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies.
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).
24-week substudy of a randomized, open-label, 2-arm, parallel-group, phase 3b study.
Multicenter study (112 centers in 11 countries).
283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea.
DAPA + SAXA vs INS.
Changes in CGM profiles, HbA1c, and PROs.
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.
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.
糖尿病治疗过程中的血糖变异性和低血糖可能会影响治疗效果和安全性，即使两种治疗方法的糖化血红蛋白（HbA1c）降低相当。
我们在达格列净联合沙格列汀（DAPA+SAXA）与甘精胰岛素（INS）的随机试验中使用了掩蔽式连续血糖监测（CGM），以比较血糖变异性和患者报告的结局（PROs）。
一项随机、开放标签、2 臂、平行组、3b 期研究的 24 周亚组研究。
多中心研究（11 个国家的 112 个中心）。
283 名二甲双胍±磺酰脲类药物控制不佳的 2 型糖尿病（T2D）成人。
DAPA+SAXA 与 INS。
CGM 谱、HbA1c 和 PROs 的变化。
DAPA+SAXA 治疗的基线 HbA1c 变化与 INS 观察到的变化相似，降幅的平均差异（95%置信区间）为-0.12%[-0.37 至 0.12%]，P=.33。CGM 分析对 DAPA+SAXA 更为有利，包括更多的时间在范围内（>3.9 和≤10mmol/L；34.3±1.9 与 28.5±1.9%，P=.033）、夜间低血糖时间更少（曲线下面积≤3.9mmol/L；0.6±0.5 与 2.7±0.5%，P=.007）以及平均血糖波动幅度较小（-0.7±0.1 与-0.3±0.1mmol/L，P=.017）。CGM 的改善与更高的满意度、更好的体重形象、更少的体重干扰以及改善的精神和情感健康状况相关。
DAPA+SAXA 和 INS 在 24 周时同样有效降低 HbA1c，但接受 DAPA+SAXA 治疗的 T2D 患者达到了更高的时间在范围内、更大的血糖波动和变异性降低、更少的低血糖时间以及改善的患者报告的健康结局。
