Jacobson Christopher, Kaiserman Kevin B, Ulloa Johanna, Pleitez Jennifer, Sylvan Joseph, Rinker Joanne, Codorniz Kevin, Lee Scott, Vakhshoori Mehrbod, Lobo Moreno Pamela, Blevins Thomas
Diabetes Treatment Center, Loma Linda University, Loma Linda, CA, USA.
MannKind Corporation, 30930 Russell Ranch Rd., #300, Westlake Village, CA, 91362, USA.
Diabetes Ther. 2025 Jun 18. doi: 10.1007/s13300-025-01760-5.
A post hoc analysis from a 90-day proof-of-concept study demonstrated increased efficacy and no new safety concerns for an ultra-rapid-acting inhaled insulin, Technosphere Insulin (TI), when a higher modified conversion dose was compared to the conversion dose in the current US prescribing insert (approx. 2 × vs approx. 1.3 × TI per rapid-acting insulin analogue [RAA] unit [U] across the 1-24 U range). This post hoc analysis evaluates the safety and efficacy of the modified conversion dose in the postprandial period.
Participants with type 1 diabetes (T1D) were randomly assigned to administer TI using the modified dosing (TI group) or continue using their automated insulin delivery (AID) system (AID controls) in this in-clinic standardized meal challenge. Postprandial glucose was measured via capillary self-monitored blood glucose over 2 h post-meal to evaluate mean peak glucose and mean peak glucose excursion.
The TI group (n = 21) demonstrated faster and lower mean peak glucose and mean peak glucose excursion vs AID controls (n = 5). Mean peak glucose and glucose excursion were reached 30 min earlier with TI. One TI + AID participant (modified dose) experienced one level 1 hypoglycemia event in the 2-h postprandial period and recovered in-clinic. No serious adverse events were reported.
TI group demonstrated a more favorable glycemic response in the 2-h postprandial period vs AID control. Data from this and previous studies suggest this higher modified conversion TI dose from subcutaneous RAA may help further reduce postprandial hyperglycemia in T1D.
ClinicalTrials.gov NCT05243628.
一项为期90天的概念验证研究的事后分析表明，与美国现行处方说明书中的转换剂量相比（在1 - 24单位范围内，每单位速效胰岛素类似物[RAA]，超速效吸入胰岛素Technosphere胰岛素[TI]的调整转换剂量约为2倍，而现行剂量约为1.3倍），超速效吸入胰岛素Technosphere胰岛素（TI）疗效增强且无新的安全问题。这项事后分析评估了调整转换剂量在餐后阶段的安全性和疗效。
在这项门诊标准化餐食挑战试验中，1型糖尿病（T1D）患者被随机分配使用调整剂量来给药TI（TI组），或继续使用他们的自动胰岛素输送（AID）系统（AID对照组）。通过餐后2小时的毛细血管自我监测血糖来测量餐后血糖，以评估平均血糖峰值和平均血糖峰值波动。
与AID对照组（n = 5）相比，TI组（n = 21）的平均血糖峰值和平均血糖峰值波动更低且出现得更快。TI组的平均血糖峰值和血糖波动在30分钟时出现。一名TI + AID参与者（调整剂量）在餐后2小时内发生了1次1级低血糖事件，并在门诊恢复。未报告严重不良事件。
与AID对照组相比，TI组在餐后2小时内显示出更有利的血糖反应。本研究及先前研究的数据表明，皮下RAA的这种更高的调整转换TI剂量可能有助于进一步降低T1D患者的餐后高血糖。
ClinicalTrials.gov NCT05243628。
