Harris Stewart B, Ajala Olubukola, Bari Basel, Liutkus Joanne, Hahn Jina, Martyn Oliver, Zwicker Deborah
Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, WCPHFM, 1465 Richmond St, London, ON, N6G 2M1, Canada.
LMC Healthcare, Alberta, Canada.
Diabetes Ther. 2021 Jun;12(6):1689-1702. doi: 10.1007/s13300-021-01063-5. Epub 2021 May 1.
The aim of the study was to examine glycaemic control and safety of insulin degludec (degludec) in patients with either type 1 diabetes (T1D) or type 2 diabetes (T2D) under routine care settings in Canada.
Data were extracted from medical records of adults with T1D or T2D who switched to degludec (± prandial insulin) from another basal insulin (± prandial insulin) ≥ 6 months prior to data collection. The primary endpoint was change in glycated haemoglobin (HbA) at 6 ± 3 months after degludec initiation. Secondary endpoints included change in hypoglycaemia rate in the 6 months before versus the 6 months after switching, and change in mean total daily insulin dose.
Of 667 patients assessed for eligibility, 626 were included. After 6 ± 3 months, HbA decreased from baseline in patients with T1D (- 0.3% [- 0.42, - 0.14]; p < 0.001) and in patients with T2D (- 0.4% [- 0.55, - 0.30]; p < 0.001). In patients with T1D, there were significant reductions in the rates of overall (rate ratio [RR] 0.70), non-severe (RR 0.69), non-severe nocturnal (RR 0.36), and severe nocturnal hypoglycaemia (RR 0.12; all p ≤ 0.004). In patients with T2D there was a significant reduction in non-severe nocturnal hypoglycaemia (RR 0.22; p < 0.001). Mean daily basal insulin dose decreased in patients with T1D (- 1.6 units [- 2.8, - 0.4]; p = 0.008); there was no significant change in patients with T2D (- 0.6 units [- 2.7, 1.4]; p = 0.543).
In routine clinical practice, improved glycaemic control was observed in patients with T1D or T2D switching to insulin degludec from other basal insulins, with either improvement or no change in hypoglycaemia rates.
ClinicalTrials.gov NCT03674866.
本研究的目的是在加拿大常规护理环境下，考察德谷胰岛素（degludec）用于1型糖尿病（T1D）或2型糖尿病（T2D）患者时的血糖控制情况及安全性。
从T1D或T2D成年患者的医疗记录中提取数据，这些患者在数据收集前至少6个月从另一种基础胰岛素（±餐时胰岛素）换用德谷胰岛素（±餐时胰岛素）。主要终点是开始使用德谷胰岛素后6±3个月糖化血红蛋白（HbA）的变化。次要终点包括换药前6个月与换药后6个月低血糖发生率的变化，以及每日胰岛素总剂量的变化。
在评估的667例符合条件的患者中，626例被纳入研究。6±3个月后，T1D患者的HbA从基线水平下降（-0.3% [-0.42, -0.14]；p<0.001），T2D患者的HbA也从基线水平下降（-0.4% [-0.55, -0.30]；p<0.001）。在T1D患者中，总体低血糖发生率（率比[RR] 0.70）、非严重低血糖发生率（RR 0.69）、非严重夜间低血糖发生率（RR 0.36）和严重夜间低血糖发生率（RR 0.12；所有p≤0.004）均显著降低。在T2D患者中，非严重夜间低血糖发生率显著降低（RR 0.22；p<0.001）。T1D患者的每日基础胰岛素平均剂量降低（-1.6单位[-2.8, -0.4]；p = 0.008）；T2D患者无显著变化（-0.6单位[-2.7, 1.4]；p = 0.543）。
在常规临床实践中，从其他基础胰岛素换用德谷胰岛素的T1D或T2D患者血糖控制得到改善，低血糖发生率有所改善或无变化。
ClinicalTrials.gov NCT03674866
