Background: Gastroparesis is a serious medical condition characterized by delayed gastric emptying and symptoms of nausea, vomiting, bloating, fullness after meals, and abdominal pain (Camilleri et al., 2018) . One-third of gastroparesis cases are related to uncontrolled diabetes (Young et al., 2020) . HBA1C levels in diabetic gastroparesis are not associated with more or less severe vomiting episodes (Parkman et al., 2016) . Individual signs and symptoms may occur more often or with greater severity in one population compared with the other due to the degree of diabetic control. Here we did a post-hoc analysis in a phase 2 study to see if there is a correlation between baseline HBA1C and baseline gastroparesis symptoms. Methods: Diabetic and idiopathic gastroparesis patients were screened to enroll in a phase 2 clinical trial. Patients with moderate to severe nausea and delayed gastric emptying would go onto be randomized to tradipitant 85mg BID or placebo for 4 weeks. Baseline clinical symptoms were measured by the Gastroparesis Core Symptom Daily Diary (GCSDD) . A post-hoc analysis was performed to correlate HBA1C with baseline gastroparesis symptoms in patients with diabetic gastroparesis. Results: Patients with diabetic gastroparesis and sufficient baseline data (n=106) had baseline nausea severity of 2.5 (1.175) and baseline HBA1C of 7.366 (1.373) . There was no correlation of baseline nausea and HBA1C levels for diabetic gastroparesis (0.021) . There was no correlation of average daily vomiting, fullness, early satiety, or abdominal pain and HBA1C levels in the diabetic gastroparesis population. Conclusion: Patients with diabetic gastroparesis experience the core signs and symptoms of gastroparesis. HBA1C levels in this population do not appear to be correlated with severity of nausea and vomiting and other core symptoms of gastroparesis. Disclosure J.L.Carlin: Employee; Vanda Pharmaceuticals, Inc. M.Fisher: Employee; Vanda Pharmaceuticals, Inc. . D.S.Madonick: Employee; Vanda Pharmaceuticals Inc. C.Kupersmith: Employee; Vanda Pharmaceuticals. P.Moszczynski: Employee; Vanda Pharmaceuticals, Inc. C.Xiao: None. G.Birznieks: Employee; Vanda Pharmaceuticals. M.H.Polymeropoulos: Other Relationship; Vanda Pharmaceuticals, Inc. .

中文翻译：

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1507-PUB：2 期临床试验中糖尿病性胃轻瘫患者的血糖控制程度与恶心和呕吐无关

背景：胃轻瘫是一种严重的疾病，其特征是胃排空延迟和恶心、呕吐、腹胀、饭后饱胀和腹痛的症状（Camilleri 等，2018）。三分之一的胃轻瘫病例与不受控制的糖尿病有关（Young 等，2020）。糖尿病性胃轻瘫中的 HBA1C 水平与或多或少的严重呕吐事件无关（Parkman 等人，2016 年）。由于糖尿病控制的程度，个体体征和症状在一个人群中可能比另一人群更频繁或更严重地发生。在这里，我们在一项 2 期研究中进行了事后分析，以查看基线 HBA1C 和基线胃轻瘫症状之间是否存在相关性。方法：筛选糖尿病和特发性胃轻瘫患者参加 2 期临床试验。中度至重度恶心和胃排空延迟的患者将被随机分配至传统的 85mg BID 或安慰剂治疗 4 周。通过胃轻瘫核心症状每日日记 (GCSDD) 测量基线临床症状。进行了事后分析，以将 HBA1C 与糖尿病性胃轻瘫患者的基线胃轻瘫症状相关联。结果：糖尿病胃轻瘫患者和足够的基线数据 (n=106) 的基线恶心严重程度为 2.5 (1.175) 和基线 HBA1C 为 7.366 (1.373)。糖尿病性胃轻瘫的基线恶心和 HBA1C 水平没有相关性 (0.021)。在糖尿病性胃轻瘫人群中，平均每日呕吐、饱腹感、早饱或腹痛与 HBA1C 水平没有相关性。结论：糖尿病性胃轻瘫患者会经历胃轻瘫的核心体征和症状。该人群中的 HBA1C 水平似乎与恶心和呕吐的严重程度以及胃轻瘫的其他核心症状无关。披露 JLCarlin：员工；Vanda Pharmaceuticals, Inc. M.Fisher：员工；万达制药公司。DSMadonick：员工；Vanda Pharmaceuticals Inc. C.Kupersmith：员工；万达制药。P.Moszczynski：员工；Vanda Pharmaceuticals, Inc. C.Xiao：没有。G.Birznieks：员工；万达制药。MHPolymeropoulos：其他关系；万达制药公司。Vanda Pharmaceuticals, Inc. M.Fisher：员工；万达制药公司。DSMadonick：员工；Vanda Pharmaceuticals Inc. C.Kupersmith：员工；万达制药。P.Moszczynski：员工；Vanda Pharmaceuticals, Inc. C.Xiao：没有。G.Birznieks：员工；万达制药。MHPolymeropoulos：其他关系；万达制药公司。Vanda Pharmaceuticals, Inc. M.Fisher：员工；万达制药公司。DSMadonick：员工；Vanda Pharmaceuticals Inc. C.Kupersmith：员工；万达制药。P.Moszczynski：员工；Vanda Pharmaceuticals, Inc. C.Xiao：没有。G.Birznieks：员工；万达制药。MHPolymeropoulos：其他关系；万达制药公司。