Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis

Inclusion Criteria: * Non pregnant, non lactating female subjects between the ages of 18 and 75 years * Willingness and ability to give written informed consent * The ability to read, understand and speak English * Prior diagnosis of Type 1 or Type 2 diabetes * Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying * A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization * Subjects of childbearing potential must agree to use contraception * Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study Exclusion Criteria: * Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility * A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product * A history of, or physical findings suggestive of, tardive dyskinesia * A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening * A history of allergy to any of the ingredients in the study drug formulation * A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS) * Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening * Renal dysfunction calculated as creatinine clearance (CrCl) \<40 mL/min at screening * Hemoglobin A1c \>11.5% at screening * Subjects who are trying to conceive, are pregnant, or are lactating