Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore.
J Diabetes Res. 2020 Feb 7;2020:8152640. doi: 10.1155/2020/8152640. eCollection 2020.
To observe whether there are sexual-related differences in response to mid- or low-premixed insulin in type 2 diabetic patients.
This was an analysis of CGM data of a previous study. After screening, patients with longstanding T2D receive a 7-day continuous subcutaneous insulin infusion (CSII) therapy, and then subjects were randomly assigned 1 : 1 into two groups receiving Novo Mix 30 or Humalog Mix 50 regimen for a 2-day phage, followed by a 4-day cross-over period. A 4-day continuous glucose monitoring (CGM) was performed during the cross-over period. The primary endpoint was the differences in glycemic control between male and female patients receiving mid- or low-premixed insulin therapy.
A total of 102 patients (52 men and 50 women) completed the study. Our data showed that male patients had significant decrease in mean glucose levels monitored by CGM after three meals during Humalog Mix 50 treatment period compared to those received Novo Mix 30 regimen (0900: 11.0 ± 2.5 vs. 12.2 ± 2.8, 1000: 9.9 ± 2.9 vs. 11.3 ± 3.1, 1200: 8.0 ± 1.9 vs. 9.1 ± 2.5, 1400: 9.2 ± 2.3 vs. 10.3 ± 2.5, and 2000: 7.3 ± 2.1 vs. 8.2 ± 2.4 mmol/L, < 0.05, respectively). In addition, male patients receiving Novo Mix 30 experienced a significantly increased hypoglycemic duration compared to those of receiving Humalog Mix 50 (0 (0, 4.8) vs. 0 (0, 0), < 0.05, respectively). In addition, male patients receiving Novo Mix 30 experienced a significantly increased hypoglycemic duration compared to those of receiving Humalog Mix 50 (0 (0, 4.8) vs. 0 (0, 0).
Our data indicate that male patients with T2D receiving mid-premixed insulin analogue regimen may have a potential benefit of improvement in glycemic control compared to female patients. This trial is registered with ClinicalTrials.gov ChiCTR-IPR-15007340.
观察中效预混或预混胰岛素治疗 2 型糖尿病患者的疗效是否存在性别差异。
这是一项对先前研究的 CGM 数据进行的分析。经过筛选，长期患有 2 型糖尿病的患者接受 7 天持续皮下胰岛素输注（CSII）治疗，然后以 1∶1 的比例随机分为两组，分别接受诺和锐 30 或优泌乐 50 方案治疗 2 天洗脱期，随后进行 4 天交叉期。在交叉期进行 4 天连续血糖监测（CGM）。主要终点是接受中效或预混胰岛素治疗的男性和女性患者的血糖控制差异。
共有 102 名患者（52 名男性和 50 名女性）完成了研究。我们的数据显示，与接受诺和锐 30 方案相比，男性患者在接受优泌乐 50 治疗期间三餐后 CGM 监测的平均血糖水平有显著下降（0900：11.0±2.5 vs. 12.2±2.8，1000：9.9±2.9 vs. 11.3±3.1，1200：8.0±1.9 vs. 9.1±2.5，1400：9.2±2.3 vs. 10.3±2.5，2000：7.3±2.1 vs. 8.2±2.4mmol/L，均<0.05）。此外，与接受优泌乐 50 治疗的患者相比，接受诺和锐 30 治疗的男性患者低血糖持续时间明显增加（0（0，4.8）vs. 0（0，0），均<0.05）。此外，与接受优泌乐 50 治疗的患者相比，接受诺和锐 30 治疗的男性患者低血糖持续时间明显增加（0（0，4.8）vs. 0（0，0）。
我们的数据表明，与女性患者相比，接受中效预混胰岛素类似物治疗的 2 型糖尿病男性患者可能在血糖控制方面有潜在获益。本试验在中国临床试验注册中心注册，注册号 ChiCTR-IPR-15007340。
