Degree of Glycemic Control Does Not Correlate with Nausea and Vomiting in Diabetic Gastroparesis Patients in a Phase 2 Clinical Trial

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. .