Malik Rayaz A, Elhadd Tarik, Alattar Abdulnabi, Al Shaikh Abdulrahman, Al Randi Muneera, Arora Ravi, Al-Sifri Saud, Akil Yasser, Magdy Amr, Naqvi Mubarak, Hassanein Mohamed
Weill Cornell Medicine - Qatar, Education City, Doha, Qatar.
Endocrine Section, Department of Medicine, Hamad Medical Corporation, Doha, Qatar.
Diabetes Ther. 2022 Mar;13(3):569-581. doi: 10.1007/s13300-022-01225-z. Epub 2022 Mar 3.
To evaluate the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) in people with type 2 diabetes mellitus (T2DM) in the Gulf region who fast during Ramadan.
ORION was a real-world, prospective, observational study in people with T2DM treated with Gla-300 during pre-Ramadan, Ramadan, and post-Ramadan periods. This subgroup analysis included 222 participants from the Gulf region (Kuwait, Saudi Arabia, United Arab Emirates, and Qatar). The primary endpoint was the percentage of participants experiencing severe and/or symptomatic documented hypoglycemia (self-monitored plasma glucose [SMPG] ≤ 70 mg/dL) during Ramadan. Changes in glycated hemoglobin (HbA), fasting plasma glucose (FPG), SMPG, body weight, insulin dose, and adverse events (AEs) were also evaluated.
The primary endpoint was reported in one (0.5%) participant during Ramadan. The incidence rate of symptomatic documented hypoglycemia (SMPG ≤ 70 mg/dL) decreased from the pre-Ramadan (3.2%) to Ramadan period (0.5%), and no severe hypoglycemia events were reported during the study. Reductions were observed in HbA (mean ± standard deviation: - 0.51 ± 0.95% [- 5.5 ± 10.4 mmol/mol]), FPG (- 13.9 ± 47.5 mg/dL), and SMPG (- 6.1 ± 27.1 mg/dL). No significant changes were observed in body weight or Gla-300 dose. AEs were reported in 11 (5.0%) participants.
In a real-world setting in the Gulf region, Gla-300 treatment in people with T2DM during Ramadan was associated with a low incidence of hypoglycemia and improved glycemic control.
CTRI/2019/02/017636.
评估在斋月期间禁食的海湾地区2型糖尿病（T2DM）患者中，300 U/mL甘精胰岛素（Gla-300）的安全性和有效性。
ORION是一项针对在斋月前、斋月期间和斋月后接受Gla-300治疗的T2DM患者的真实世界、前瞻性观察性研究。该亚组分析纳入了来自海湾地区（科威特、沙特阿拉伯、阿拉伯联合酋长国和卡塔尔）的222名参与者。主要终点是斋月期间经历严重和/或有症状记录的低血糖（自我监测血浆葡萄糖[SMPG]≤70 mg/dL）的参与者百分比。还评估了糖化血红蛋白（HbA）、空腹血糖（FPG）、SMPG、体重、胰岛素剂量和不良事件（AE）的变化。
斋月期间有1名（0.5%）参与者报告了主要终点。有症状记录的低血糖（SMPG≤70 mg/dL）发生率从斋月前的3.2%降至斋月期间的0.5%，研究期间未报告严重低血糖事件。观察到HbA（平均值±标准差：-0.51±0.95%[-5.5±10.4 mmol/mol]）、FPG（-13.9±47.5 mg/dL）和SMPG（-6.1±27.1 mg/dL）有所降低。体重或Gla-300剂量未观察到显著变化。11名（5.0%）参与者报告了不良事件。
在海湾地区的真实世界环境中，斋月期间T2DM患者接受Gla-300治疗与低血糖发生率低和血糖控制改善相关。
CTRI/2019/02/017636。
