Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial.
Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial.
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DOI：
10.1111/pedi.13220
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发表时间：
2021-08
影响因子：
3.4
通讯作者：
Danne T
中科院分区：
文献类型：
--
作者：
Battelino T;Tehranchi R;Bailey T;Dovc K;Melgaard A;Yager Stone J;Woerner S;von dem Berge T;DiMeglio L;Danne T
达西高血糖素是一种下一代即用型水基高血糖素类似物，已被开发用于治疗糖尿病患者的严重低血糖。这项试验的目的是评估达西糖素治疗儿童1型糖尿病(T1 DM)的安全性和有效性。研究对象为患有T1 DM的儿童和青少年(6-17 岁)。在这项随机双盲试验中，42名参与者被随机分配(2：1：1)，在胰岛素诱导的低血糖期间，单次皮下(SC)注射大豆素(0.6 mg)、安慰剂或重组胰高血糖素(葡萄糖原，按标签剂量)。主要终点是血糖(PG)恢复的时间(首次PG在治疗开始后增加≥20 mg/dL，而不抢救静脉血糖)。主要的比较是大豆素和安慰剂；高血糖素作为参照物。SC注射后血糖恢复的中位时间(95%可信区间)：大黄素为10 分钟(8-12)，安慰剂为30分钟(20--)(P <； .001)；胰高血糖素的中位时间为10 分钟(8-12)，这还不包括重建冻干粉末所需的时间。与安慰剂组11名患者中的2名(18%)相比，达西他汀组和高血糖素组的所有参与者在服药后20 分钟内血糖均有所恢复。最常见的不良事件是恶心和呕吐，正如胰高血糖素治疗所预期的那样。与成人3期试验一致，在胰岛素诱导的低血糖后，患有T1 DM的儿童和青少年迅速有效地恢复了PG水平，总体安全性与高血糖素相似。
Dasiglucagon, a next‐generation, ready‐to‐use aqueous glucagon analog formulation, has been developed to treat severe hypoglycemia in individuals with diabetes. The aim of this trial was to evaluate the safety and efficacy of dasiglucagon in pediatric individuals with type 1 diabetes (T1DM). Participants were children and adolescents (6–17 years) with T1DM. In this randomized double‐blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin‐induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery (first PG increase ≥20 mg/dL after treatment initiation without rescue intravenous glucose). The primary comparison was dasiglucagon vs. placebo; glucagon acted as a reference. The median time (95% confidence interval) to PG recovery following SC injection was 10 min (8–12) for dasiglucagon vs. 30 min (20 to –) for placebo (P < .001); the median time for glucagon was 10 min (8–12), which did not include the time taken to reconstitute the lyophilized powder. PG recovery was achieved in all participants in the dasiglucagon and glucagon groups within 20 min of dosing compared to 2 out of 11 patients (18%) with placebo. The most frequent adverse events were nausea and vomiting, as expected with glucagon treatment. Consistent with adult phase 3 trials, dasiglucagon rapidly and effectively restored PG levels following insulin‐induced hypoglycemia in children and adolescents with T1DM, with an overall safety profile similar to glucagon.
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