Luo Yong, Ni Wen-Ji, Ding B O, Xu Xiang-Hong, Ye Lei, Ma Jian-Hua, Zhu Jian
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
National Heart Research Institute Singapore, National Heart Centre, Singapore, Singapore.
Diabetes Ther. 2019 Feb;10(1):205-213. doi: 10.1007/s13300-018-0545-7. Epub 2019 Jan 4.
The aim of this study was to determine the clinical efficacy of preprandial and postprandial Prandilin 25 (premixed insulin lispro 25) administration in patients with newly diagnosed type 2 diabetes mellitus (T2DM) using a continuous glucose monitoring (CGM) system.
This was a single-center, self-controlled comparative clinical trial. Newly diagnosed T2DM patients with hemoglobin A1c > 8.0% were hospitalized and received Prandilin 25 plus metformin treatment. Glycemic control was reached after a 7-to-8-day run-in period. Patients underwent 2 days of treatment consisting of preprandial Prandilin 25 on day 1 and postprandial Prandilin 25 on day 2 at the same dosage. The primary outcome was the 24-h mean amplitude of glycemic excursion (24 hMAGE); secondary outcomes were other daily glycemic variability parameters, including 24-h mean blood glucose (24hMBG), 24-h standard deviation of blood glucose (24hSDBG), large amplitude of glycemic excursion (LAGE), incremental area under the curve (AUC) values for different glucose levels, postprandial glucose excursion, and incidence of hypoglycemia, which were assessed using a CGM system.
Eighty-five patients completed this study. There was no statistically significant difference in 24hMAGE, 24hMBG, 24hSDBG, or LAGE between the preprandial injection group and the postprandial injection group. Similarly, there was no between-treatment difference in the AUC for a blood glucose level below 3.9 mmol/L, in the AUC for a blood glucose level above 10.0 mmol/L, or in the percentages of time that the blood glucose level was below 3.9 mmol/L or above 10.0 mmol/L. Further analysis showed that the pre-meal glucose, peak height, and time to peak after each meal, the relative areas under the CGM curve at 1-4 h after each meal, as well as the incidence of hypoglycemia, were similar for the preprandial and postprandial Prandilin 25 groups.
In patients with T2DM managed with premixed insulin lispro 25, postprandial injection (within 30 min of meal onset) may be an acceptable alternative to preprandial injection when the regular preprandial insulin dose is omitted.
Chinese Clinical Trial Register identifier: ChiCTR1800015828.
本研究旨在使用连续血糖监测（CGM）系统，确定新诊断的2型糖尿病（T2DM）患者餐前和餐后注射普朗林25（赖脯胰岛素25预混剂）的临床疗效。
这是一项单中心、自身对照的比较临床试验。新诊断的糖化血红蛋白A1c>8.0%的T2DM患者住院并接受普朗林25加二甲双胍治疗。经过7至8天的导入期后达到血糖控制。患者接受为期2天的治疗，第1天为餐前注射普朗林25，第2天为餐后注射相同剂量的普朗林25。主要结局是24小时血糖波动平均幅度（24hMAGE）；次要结局是其他每日血糖变异性参数，包括24小时平均血糖（24hMBG）、24小时血糖标准差（24hSDBG）、血糖波动大振幅（LAGE）、不同血糖水平下的曲线下增量面积（AUC）值、餐后血糖波动以及低血糖发生率，使用CGM系统进行评估。
85名患者完成了本研究。餐前注射组和餐后注射组在24hMAGE、24hMBG、24hSDBG或LAGE方面无统计学显著差异。同样，血糖水平低于3.9 mmol/L时的AUC、血糖水平高于10.0 mmol/L时的AUC，或血糖水平低于3.9 mmol/L或高于10.0 mmol/L的时间百分比在治疗组之间也无差异。进一步分析表明，餐前和餐后普朗林25组的餐前血糖、峰值高度、每餐餐后达到峰值的时间、每餐餐后1至4小时CGM曲线下的相对面积以及低血糖发生率相似。
在使用赖脯胰岛素25预混剂治疗的T2DM患者中，当省略常规餐前胰岛素剂量时，餐后注射（进餐开始后30分钟内）可能是餐前注射的可接受替代方案。
中国临床试验注册标识符：ChiCTR1800015828。
