Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, North Carolina.
International Diabetes Center, Minneapolis, Minnesota.
Diabetes Obes Metab. 2018 Dec;20(12):2885-2893. doi: 10.1111/dom.13545. Epub 2018 Oct 10.
To evaluate the efficacy and safety of mealtime or post-meal fast-acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D).
This multicentre, treat-to-target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov) randomized participants to double-blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open-label post-meal faster aspart (n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect.
Non-inferiority for the change from baseline in HbA1c was confirmed for mealtime and post-meal faster aspart vs IAsp (estimated treatment difference [ETD]: 95%CI, -0.02% [-0.11; 0.07] and 0.10% [0.004; 0.19], respectively). Mealtime faster aspart was superior to IAsp for 1-hour PPG increment using a meal test (ETD, -0.90 mmol/L [-1.36; -0.45]; P < 0.001). Self-monitored 1-hour PPG increment favoured faster aspart at breakfast (ETD, -0.58 mmol/L [-0.99; -0.17]; P = 0.006) and across all meals (-0.48 mmol/L [-0.74; -0.21]; P < 0.001). Safety profiles and overall rate of severe or blood glucose-confirmed hypoglycaemia were similar between treatments, but significantly less hypoglycaemia was seen 3 to 4 hours after meals with mealtime faster aspart.
Mealtime and post-meal faster aspart in conjunction with insulin degludec provided effective glycaemic control compared with IAsp, with no increased safety risk. Mealtime faster aspart provided PPG control superior to that of IAsp.
评估餐时或餐后速效门冬胰岛素（速秀霖）与餐时门冬胰岛素（IAsp）联合胰岛素德谷胰岛素在 1 型糖尿病（T1D）患者中的疗效和安全性。
这是一项多中心、以目标为导向的试验（临床试验注册：NCT02500706，ClinicalTrials.gov），将参与者随机分为双盲餐时速秀霖（n=342）、餐时 IAsp（n=342）或开放标签餐后速秀霖（n=341）组。主要终点是从随机分组后 26 周的基线 HbA1c 变化。所有可用信息，无论治疗是否中断，均用于评估疗效。
餐时和餐后速秀霖与 IAsp 相比，HbA1c 从基线的变化均证实非劣效性（估计治疗差异[ETD]：-0.02%[-0.11；0.07]和 0.10%[0.004；0.19]）。使用进餐试验时，餐时速秀霖较 IAsp 能更好地降低 1 小时餐后血糖升高（ETD，-0.90mmol/L[-1.36；-0.45]；P<0.001）。自我监测的 1 小时餐后血糖升高在早餐时（ETD，-0.58mmol/L[-0.99；-0.17]；P=0.006）和所有餐次时（ETD，-0.48mmol/L[-0.74；-0.21]；P<0.001）均有利于速秀霖。治疗之间的安全性概况和严重或血糖确认的低血糖发生率相似，但在用餐时使用速秀霖后 3 至 4 小时，低血糖的发生率明显降低。
餐时和餐后速秀霖联合胰岛素德谷胰岛素与 IAsp 相比，可提供有效的血糖控制，且无增加的安全性风险。餐时速秀霖提供的餐后血糖控制优于 IAsp。
