南亚地区斋月期间禁食的 2 型糖尿病成年患者使用 Gla-300 的真实世界观察性研究：ORION 研究的亚组分析
A Real-World Observational Study of Gla-300 in Adults with Type 2 Diabetes Who Fast During Ramadan in the South Asia Region: A Subgroup Analysis of the ORION Study.
作者信息
Hassanein Mohamed, Sahay Rakesh, Hasan Mohammad I, Hussain Arshad, Mittal Vinod, Mohammed Riyaz, Shaikh Zaman, Farishta Faraz, Mohanasundaram Senthilnathan, Naqvi Mubarak, Nair Arjun, Ali Zubair
机构信息
Dubai Hospital, Dubai Health Authority, 222 Al Khaleej Road, Deira, 7272, Dubai, United Arab Emirates.
Osmania Medical College, Hyderabad, 500095, Telangana, India.
出版信息
Diabetes Ther. 2022 Apr;13(4):747-759. doi: 10.1007/s13300-022-01234-y. Epub 2022 Mar 14.
INTRODUCTION
In this ORION study subgroup analysis, the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) was evaluated in people from the South Asia region with type 2 diabetes mellitus (T2DM) before, during, and after Ramadan, in a real-world setting.
METHODS
The ORION study was a real-world, prospective, observational, non-comparative study conducted across 11 countries. The current subgroup analysis included participants from the South Asia region (India and Pakistan) who fasted during Ramadan. The primary endpoint was the percentage of participants experiencing ≥ 1 event of severe and/or symptomatic documented hypoglycemia with self-monitored plasma glucose (SMPG) ≤ 70 mg/dL during Ramadan. Secondary endpoints analyzed were changes in glycated hemoglobin (HbA), fasting plasma glucose (FPG), SMPG, insulin dose, and adverse events (AEs).
RESULTS
This subgroup analysis included 106 participants from the South Asia region with mean (standard deviation) age of 51.3 (10.9) years and mean number of 29.8 (4.0) fasting days. The number of severe and/or symptomatic documented hypoglycemia events was low in the pre-Ramadan (SMPG ≤ 70 mg/dL: 1 event [0.9%]; SMPG < 54 mg/dL: 1 event [0.9%]) and Ramadan periods (SMPG ≤ 70 mg/dL: 1 event [0.9%]; SMPG < 54 mg/dL: 0 events), and none in the post-Ramadan period. One participant reported severe hypoglycemia (any time of the day: nocturnal or daytime) throughout the pre-Ramadan period. A reduction in HbA and FPG levels was seen during the pre- to post-Ramadan period; however, a slight increase in SMPG levels was reported during this same period. Gla-300 daily dose was reduced from 21.6 (9.6) U to 20.2 (8.9) U during the pre-Ramadan to Ramadan period. The incidence of AEs was 1.9%.
CONCLUSIONS
The real-world data from the ORION study indicate that Gla-300 is effective, with low risk of hypoglycemia, for the management of T2DM during Ramadan in the South Asian population.
TRIAL REGISTRATION
CTRI/2019/02/017636.
引言
在这项ORION研究的亚组分析中，于斋月前、斋月期间及斋月后，在实际环境中评估了300 U/mL甘精胰岛素（Gla-300）在南亚地区2型糖尿病（T2DM）患者中的安全性和有效性。
方法
ORION研究是一项在11个国家开展的实际、前瞻性、观察性、非对照研究。当前的亚组分析纳入了来自南亚地区（印度和巴基斯坦）在斋月期间禁食的参与者。主要终点是斋月期间自我监测的血浆葡萄糖（SMPG）≤70 mg/dL时发生≥1次严重和/或有症状的记录在案的低血糖事件的参与者百分比。分析的次要终点包括糖化血红蛋白（HbA）、空腹血糖（FPG）、SMPG、胰岛素剂量和不良事件（AE）的变化。
结果
该亚组分析纳入了106名来自南亚地区的参与者，平均（标准差）年龄为51.3（10.9）岁，平均禁食天数为29.8（4.0）天。斋月前（SMPG≤70 mg/dL：1例事件[0.9%]；SMPG<54 mg/dL：1例事件[0.9%]）和斋月期间（SMPG≤70 mg/dL：1例事件[0.9%]；SMPG<54 mg/dL：0例事件）严重和/或有症状的记录在案的低血糖事件数量较低，斋月后期间无此类事件。1名参与者在整个斋月前期间报告了严重低血糖（一天中的任何时间：夜间或白天）。在斋月前至斋月后期间观察到HbA和FPG水平降低；然而，在此期间报告SMPG水平略有升高。斋月前至斋月期间，Gla-300每日剂量从21.6（9.6）U降至20.2（8.9）U。AE的发生率为1.9%。
结论
ORION研究的实际数据表明，Gla-300对南亚人群在斋月期间管理T2DM有效，低血糖风险低。
试验注册
CTRI/2019/02/017636。
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