Dasiglucagon 有效缓解减重术后餐后低血糖：一项随机、双盲、安慰剂对照、交叉试验。
Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.
机构信息
Center for Clinical Metabolic Research, Copenhagen University Hospital - Herlev and Gentofte, Hellerup, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
Diabetes Care. 2022 Jun 2;45(6):1476-1481. doi: 10.2337/dc21-2252.
OBJECTIVE
To investigate the efficacy and safety of dasiglucagon, a novel stable glucagon analog in a liquid formulation, in Roux-en-Y gastric bypass (RYGB)-operated individuals suffering from postbariatric hypoglycemia (PBH).
RESEARCH DESIGN AND METHODS
In a randomized, double-blind, placebo-controlled, crossover trial, 10 RYGB-operated participants with continuous glucose monitoring-verified PBH were randomly assigned to 3 trial days, each consisting of a 240-min standardized liquid mixed-meal test with the subcutaneous injection of placebo or 80 μg or 200 μg dasiglucagon.
RESULTS
Compared with placebo, treatment with both 80 and 200 μg dasiglucagon raised nadir plasma glucose (PG) (placebo: 3.0 ± 0.2 mmol/L [mean ± SEM]; 80 μg dasiglucagon: 3.9 ± 0.3 mmol/L, P = 0.002; 200 μg dasiglucagon: 4.5 ± 0.2 mmol/L, P = 0.0002) and reduced time in hypoglycemia (PG <3.9 mmol/L) by 70.0 min (P = 0.030 and P = 0.008).
CONCLUSIONS
Single-dose administration of dasiglucagon effectively mitigated postprandial hypoglycemia.
目的
研究新型液体配方稳定型胰高血糖素类似物 dasiglucagon 在 Roux-en-Y 胃旁路（RYGB）手术后发生减重后低血糖（PBH）的个体中的疗效和安全性。
研究设计和方法
在一项随机、双盲、安慰剂对照、交叉试验中，10 名接受 RYGB 手术且经连续血糖监测证实存在 PBH 的参与者被随机分配到 3 个试验日，每个试验日包括 240 分钟的标准化液体混合餐测试，皮下注射安慰剂或 80 μg 或 200 μg dasiglucagon。
结果
与安慰剂相比，使用 80 μg 和 200 μg dasiglucagon 治疗均能升高血糖低谷（PG）（安慰剂：3.0 ± 0.2 mmol/L [均值 ± SEM]；80 μg dasiglucagon：3.9 ± 0.3 mmol/L，P = 0.002；200 μg dasiglucagon：4.5 ± 0.2 mmol/L，P = 0.0002）并减少 70.0 分钟的低血糖时间（PG <3.9 mmol/L）（P = 0.030 和 P = 0.008）。
结论
单次给予 dasiglucagon 可有效缓解餐后低血糖。
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