Fadini Gian Paolo, Giordano Carla, Salvi Laura, Nicolucci Antonio
Department of Medicine, University of Padova, Padua, Italy.
Section of Endocrinology, Diabetology and Metabolism, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
Diabetes Ther. 2020 Dec;11(12):2909-2920. doi: 10.1007/s13300-020-00936-5. Epub 2020 Oct 3.
To evaluate in an Italian real-world setting the safety and effectiveness of insulin degludec 100 units/mL, given once daily in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) after switching from other basal insulins.
ReFLeCT was a multicenter, prospective, observational study conducted across seven European countries which involved adult patients whose physician planned to switch their medication from basal insulin to insulin degludec. The primary outcome was the change in the number of hypoglycemic episodes before and after the switch to insulin degludec. Results are expressed as 12-month follow-up/baseline incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs).
The Italian cohort of the ReFLect study comprised 148 patients with T1DM and 311 patients with T2DM. In patients with T1DM, the switch to insulin degludec was associated with significantly lower rates of overall (IRR 0.69, 95% CI 0.57-0.82), non-severe (IRR 0.72, 95% CI 0.60-0.85), and nocturnal hypoglycemia (IRR 0.46, 95% CI 0.31-0.69). Following the switch, hemoglobin A (HbA) levels decreased significantly by 0.35% (95% CI - 0.50 to - 0.20), with no significant changes in fasting plasma glucose (FPG) and basal insulin dose. Body weight increased by 0.83 kg (95% CI 0.16-1.50). In patients with T2DM, significant reductions in the rates of overall (IRR 0.40, 95% CI 0.29-0.55), non-severe (IRR 0.47, 95% CI 0.34-0.63), and nocturnal hypoglycemia (IRR 0.27, 95% CI 0.09-0.86) were documented. HbA and FPG decreased significantly by 0.45% (95% CI - 0.58 to - 0.31) and 0.90 mmol/L (95% CI - 1.21 to - 0.59], respectively, with no significant changes in basal insulin dose or body weight. Treatment satisfaction significantly improved in both diabetes types.
In Italian routine clinical practice, switching from other basal insulins to insulin degludec reduced the total episodes of hypoglycemia and improved glycemic control and treatment satisfaction in patients with T1DM and T2DM.
ClinicalTrials.gov NCT02392117.
在意大利的真实临床环境中，评估100单位/毫升的德谷胰岛素在1型糖尿病（T1DM）和2型糖尿病（T2DM）患者从其他基础胰岛素转换后每日一次给药的安全性和有效性。
ReFLeCT是一项在七个欧洲国家开展的多中心、前瞻性观察性研究，纳入了其医生计划将基础胰岛素治疗转换为德谷胰岛素治疗的成年患者。主要结局是转换为德谷胰岛素前后低血糖发作次数的变化。结果以12个月随访/基线发病率比（IRR）及95%置信区间（95%CI）表示。
ReFLeCT研究的意大利队列包括148例T1DM患者和311例T2DM患者。在T1DM患者中，转换为德谷胰岛素与总体（IRR 0.69，95%CI 0.57 - 0.82）、非严重（IRR 0.72，95%CI 0.60 - 0.85）和夜间低血糖发生率显著降低相关（IRR 0.46，95%CI 0.31 - 0.69）。转换后，糖化血红蛋白（HbA）水平显著降低0.35%（95%CI - 0.50至 - 0.20），空腹血糖（FPG）和基础胰岛素剂量无显著变化。体重增加0.83千克（95%CI 0.16 - 1.50）。在T2DM患者中，总体（IRR 0.40，95%CI 0.29 - 0.55）、非严重（IRR 0.47，95%CI 0.34 - 0.63）和夜间低血糖发生率显著降低（IRR 0.27，95%CI 0.09 - 0.86）。HbA和FPG分别显著降低0.45%（95%CI - 0.58至 - 0.31）和0.90毫摩尔/升（95%CI - 1.21至 - 0.59），基础胰岛素剂量和体重无显著变化。两种糖尿病类型的治疗满意度均显著提高。
在意大利的常规临床实践中，从其他基础胰岛素转换为德谷胰岛素可减少T1DM和T2DM患者的低血糖总发作次数，并改善血糖控制和治疗满意度。
ClinicalTrials.gov NCT02392117
