Background & Aims: Metoclopramide nasal spray, unlike oral tablets, is absorbed even when patients have delayed gastric emptying or nausea and vomiting. We performed a randomized phase 2b study to evaluate the efficacy and safety of 10-mg and 14-mg metoclopramide nasal spray vs placebo in patients with diabetes and gastroparesis.
Methods: We performed a multicenter, double-blind study of 285 subjects (71% female) with type 1 or type 2 diabetes and a previous diagnosis of gastroparesis.