Kesavadev Jothydev, Murthy L Sreenivasa, Chaudhury Tirthankar, Yalamanchi Sadasiva Rao, Giri J, Gupta Sunil, Phatak Sanjeev, Modi K D, Chatterjee Sanjay, Manjunath Aparna, Revanna Manjunatha, Bhattacharya Arpandev
Jothydev's Diabetes Research Centre, Thiruvananthapuram, Kerala, India.
Life Care Hospital & Research Centre, Bengaluru, Karnataka, India.
Metabol Open. 2022 Apr 18;14:100184. doi: 10.1016/j.metop.2022.100184. eCollection 2022 Jun.
This post-authorization safety study (PASS) was conducted to evaluate the long-term safety and effectiveness of insulin degludec in patients with diabetes mellitus (DM) requiring insulin therapy in routine clinical practice in India.
Data on glycated hemoglobin (HbA1c) and adverse events (AEs) were collected up to 12 months after insulin degludec initiation.
A total of 1057 adult patients with DM were enrolled, including 60.07% males with the mean duration of 22.2 ± 21.90 years with type 1 DM and 10.1 ± 7.37 years with type 2 DM and the mean HbA1c of 9.6 ± 1.9%. Insulin degludec was prescribed to improve HbA1c and fasting plasma glucose (FPG). Insulin degludec daily dose was increased from 14.8 ± 8.0 U to 18.0 ± 9.46 U over 12 months resulting in a significant decrease of HbA1c by 1.8 ± 1.68% compared with baseline. There were 84 events of confirmed hypoglycemia in 51 patients during the 12-month follow-up period, and 44 AEs were reported in 2.6% of patients, of which 2 AEs were serious and unrelated to the drug.
Insulin degludec is well tolerated in patients with DM. It improves glycemic control with reduced HbA1c, FPG, and postprandial glucose, with a low risk of hypoglycemia.
开展本授权后安全性研究（PASS），以评估在印度常规临床实践中，德谷胰岛素用于需要胰岛素治疗的糖尿病（DM）患者的长期安全性和有效性。
收集德谷胰岛素起始治疗后长达12个月的糖化血红蛋白（HbA1c）和不良事件（AE）数据。
共纳入1057例成年DM患者，其中男性占60.07%，1型DM平均病程为22.2±21.90年，2型DM平均病程为10.1±7.37年，平均HbA1c为9.6±1.9%。使用德谷胰岛素的目的是改善HbA1c和空腹血糖（FPG）。在12个月内，德谷胰岛素的每日剂量从14.8±8.0 U增加至18.0±9.46 U，与基线相比，HbA1c显著降低了1.8±1.68%。在12个月的随访期内，51例患者发生了84次确诊低血糖事件，2.6%的患者报告了44例AE，其中2例严重AE与药物无关。
DM患者对德谷胰岛素耐受性良好。它可改善血糖控制，降低HbA1c、FPG和餐后血糖，低血糖风险较低。
