Profil, Neuss, Germany.
Adocia, Lyon, France.
Diabetes Obes Metab. 2018 Nov;20(11):2627-2632. doi: 10.1111/dom.13442. Epub 2018 Jul 12.
To investigate the safety and efficacy of BioChaperone Lispo (BCLIS), an ultra-rapid formulation of insulin lispro (LIS) in people with type 1 diabetes.
In this randomized, double-blind study, participants self-administered individualized bolus doses of BCLIS or LIS during two 14-day periods in a crossover fashion. Postprandial blood glucose (BG) was assessed after individualized solid mixed meal tests (MMTs) (50% carbohydrate, 29% fat, 21% protein), with additional randomization for the sequence of timing of insulin administration, immediately (t0), 15 minutes before (t - 15) and 15 minutes after (t + 15) meal start on days 1, 2 and 3, and with t0 administration on day 14. Pharmacokinetic (PK) variables were assessed for t0 MMTs. Participants also used individualized BCLIS or LIS doses immediately before meals during two 10-day outpatient periods with an unchanged basal insulin regimen.
Overall, 35 participants completed both treatment periods. In MMTs with t0 administration, the higher early postprandial PK exposure of BCLIS led to significant reductions in 1- to 2-hour postprandial BG excursions by 30% to 40% vs LIS and the accelerated absorption and action of BCLIS persisted over 14 days. There was no difference in glucose excursion over the full 360-minute postprandial period. Postprandial BG control was similar between BCLIS injected at t + 15 and LIS injected at t0. BCLIS was shown to have safety and tolerability similar to LIS. No injection site reactions occurred with BCLIS.
BCLIS was well tolerated and safe over 14 days of treatment and significantly improved postprandial BG vs LIS when administered at mealtime.
研究 BioChaperoneLispo（BCLIS），即胰岛素赖脯（LIS）的超快速制剂，在 1 型糖尿病患者中的安全性和有效性。
在这项随机、双盲研究中，参与者在交叉设计下以两种方式 14 天内自行给予 BCLIS 或 LIS 的个体化餐时剂量。在个体化混合餐测试（MMT）后评估餐后血糖（BG）（50%碳水化合物、29%脂肪、21%蛋白质），并对胰岛素给药时间的顺序进行额外随机分组，即第 1、2 和 3 天的餐时即刻（t0）、餐前 15 分钟（t-15）和餐后 15 分钟（t+15），第 14 天 t0 给药。评估 t0 MMT 的药代动力学（PK）变量。在两个 10 天的门诊期间，参与者还使用个体化的 BCLIS 或 LIS 剂量在餐前立即给药，且基础胰岛素方案不变。
总体而言，35 名参与者完成了两个治疗期。在 t0 给药的 MMT 中，BCLIS 的早期餐后 PK 暴露更高，导致 1 至 2 小时的餐后 BG 波动降低 30%至 40%，与 LIS 相比，BCLIS 的吸收和作用加速持续 14 天。在整个 360 分钟的餐后期间，血糖波动没有差异。t+15 时注射 BCLIS 与 t0 时注射 LIS 的餐后 BG 控制相似。BCLIS 的安全性和耐受性与 LIS 相似。BCLIS 未发生注射部位反应。
BCLIS 在 14 天的治疗中耐受良好且安全，与 LIS 相比，餐时给药可显著改善餐后 BG。
