在 1 型糖尿病成人患者中，与胰岛素联合使用索格列净可改善达标时间和血糖变异性：inTandem 项目 24 周连续血糖监测数据的汇总分析。
Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.
机构信息
Department of Diabetes, Endocrinology, and Clinical Research, Children's and Youth Hospital Auf der Bult, Hannover Medical School, Hannover, Germany
L'institut du thorax, Department of Endocrinology, CIC 1413 INSERM, CHU Nantes, Nantes, France.
出版信息
Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.
OBJECTIVE
To evaluate effects of the dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibitor sotagliflozin in combination with insulin on glucose time in range (TIR) and glucose excursions, postprandial glucose (PPG), and other glycemic metrics in adults with type 1 diabetes using masked continuous glucose monitoring (CGM).
RESEARCH DESIGN AND METHODS
Data sets from the inTandem1 (clinical trial reg. no. NCT02384941) and inTandem2 (clinical trial reg. no. NCT02421510) double-blind randomized trials evaluating sotagliflozin versus placebo in adults with type 1 diabetes treated with optimized insulin were pooled for analyses of masked CGM data from a subset of participants in each trial. The pooled cohort included patients randomized to receive placebo ( = 93), sotagliflozin 200 mg ( = 89), or sotagliflozin 400 mg ( = 96). The primary outcome was change from baseline to week 24 in glucose TIR (3.9-10.0 mmol/L [70-180 mg/dL]). Secondary end points included time below and above the target range and 2-h PPG level assessed after a standardized mixed meal.
RESULTS
Mean percentage of glucose TIR/percentage time spent at <3.9 mmol/L (<70 mg/dL) during week 24 was 51.6%/5.9%, 57.8%/5.5%, and 64.2%/5.5% with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively, which corresponded to a placebo-adjusted change from a baseline of +5.4%/-0.3% ( = 0.026; +1.3/-0.1 h/day) for sotagliflozin 200 mg and +11.7%/-0.1% ( < 0.001; +2.8/-0.02 h/day) for sotagliflozin 400 mg. Placebo-adjusted PPG reductions were 1.9 ± 0.7 mmol/L (35 ± 13 mg/dL; = 0.004) and 2.8 ± 0.7 mmol/L (50 ± 13 mg/dL; < 0.001) with sotagliflozin 200 and 400 mg, respectively.
CONCLUSIONS
Combined with optimized insulin in type 1 diabetes, sotagliflozin significantly increased glucose TIR without increasing time spent at <3.9 mmol/L and reduced PPG, thereby improving glycemic control.
目的
使用掩蔽式连续血糖监测（CGM）评估钠-葡萄糖共转运蛋白 2（SGLT）和钠-葡萄糖共转运蛋白 1（SGLT）双重抑制剂索格列净联合胰岛素对 1 型糖尿病成人患者血糖时间在目标范围内（TIR）和血糖波动、餐后血糖（PPG）及其他血糖指标的影响。
研究设计和方法
在两项双盲随机临床试验 inTandem1（临床试验注册号：NCT02384941）和 inTandem2（临床试验注册号：NCT02421510）中，对接受优化胰岛素治疗的 1 型糖尿病成人患者使用索格列净与安慰剂进行了评估，对两项试验中每个试验的亚组参与者的掩蔽式 CGM 数据进行了分析。汇总队列包括接受安慰剂（n = 93）、索格列净 200 mg（n = 89）或索格列净 400 mg（n = 96）治疗的患者。主要结局是从基线到第 24 周时葡萄糖 TIR（3.9-10.0 mmol/L [70-180 mg/dL]）的变化。次要终点包括低于和高于目标范围的时间以及标准化混合餐后 2 小时的 PPG 水平。
结果
在第 24 周时，与安慰剂相比，索格列净 200 mg 和索格列净 400 mg 组的葡萄糖 TIR 百分比（%）/血糖<3.9 mmol/L（<70 mg/dL）的时间百分比分别为+5.4%/-0.3%（ = 0.026；+1.3/-0.1 h/d）和+11.7%/-0.1%（ < 0.001；+2.8/-0.02 h/d），分别对应于安慰剂调整后的变化（n = 93）。索格列净 200 mg 和索格列净 400 mg 组的 PPG 降低分别为 1.9 ± 0.7 mmol/L（35 ± 13 mg/dL； = 0.004）和 2.8 ± 0.7 mmol/L（50 ± 13 mg/dL； < 0.001）。
结论
在 1 型糖尿病患者中，联合优化胰岛素治疗，索格列净可显著增加葡萄糖 TIR，同时不增加血糖<3.9 mmol/L 的时间，降低 PPG，从而改善血糖控制。
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