Sethi Bipin, Al-Rubeaan Khalid, Unubol Mustafa, Mabunay Maria A, Berthou Baptiste, Pilorget Valerie, Vethakkan Shireene R, Frechtel Gustavo
Care Hospital, Hyderabad, 500034, India.
Research and Scientific Center Sultan Bin Abdulaziz Humanitarian City, Riyadh, Saudi Arabia.
Diabetes Ther. 2022 Jul;13(7):1395-1408. doi: 10.1007/s13300-022-01271-7. Epub 2022 Jun 17.
The efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.
The ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA] 7.5-10%) on BI were switched to Gla-300. The primary endpoint was change in HbA from baseline to 26 weeks. Key secondary endpoints were changes in HbA (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.
A total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA (- 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.
In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.
NCT03760991.
在北美和西欧人群中已证实，基础胰岛素（BI）治疗血糖控制不佳的2型糖尿病（T2DM）患者换用甘精胰岛素300 U/mL（Gla-300）的有效性和安全性；然而，来自其他不同种族地理区域的数据有限。ARTEMIS-DM研究旨在评估Gla-300在亚洲、拉丁美洲和中东非洲地区BI治疗血糖控制不佳的T2DM患者中的有效性和安全性。
ARTEMIS-DM是一项为期26周的前瞻性、干预性、单臂IV期研究（NCT03760991）。之前使用BI血糖控制不佳（糖化血红蛋白[HbA] 7.5-10%）的T2DM成年患者换用Gla-300。主要终点是从基线到26周时HbA的变化。关键次要终点是从基线到26周时HbA（第12周）、空腹血糖（FPG）、自我监测血糖（SMPG）和BI剂量的变化。还评估了Gla-300的安全性和耐受性。
共纳入372名参与者（50%为男性），平均（标准差[SD]）年龄60.9（10.0）岁，糖尿病病程13.11（7.48）年，基线HbA为8.67（0.77）%（71.22 [8.44] mmol/mol）。共有222名（59.7%）参与者之前使用100 U/mL甘精胰岛素，107名（28.8%）参与者之前使用中性鱼精蛋白锌胰岛素作为基础胰岛素。在第26周时，平均HbA（主要终点）、FPG和SMPG水平有临床显著降低。采用预定义的滴定算法，Gla-300的平均剂量从基线时的27.48 U（0.35 U/kg）增加到第26周时的39.01 U（0.50 U/kg）。20.4%的参与者发生低血糖事件；1名（0.3%）参与者发生严重低血糖事件。
在之前使用BI血糖控制不佳的T2DM患者中，通过算法进行最佳滴定换用Gla-300与多个地理区域改善血糖控制及低血糖发生率低相关。
NCT03760991。
