Restoration of Hypoglycemia Awareness With Metoclopramide

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simon Fisher
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metoclopramide

Criteria

Inclusion Criteria:

• Subjects with Type 1 Diabetes Mellitus

• Diabetes duration > 5 years

• Hemoglobin A1c ≤ 9%

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

• History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency

• History of stroke or brain disease

• History of genitourinary obstruction or urinary retention

• Advanced liver disease

• Active anemia with hemoglobin less than 11 g/dL

• Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period

• Uncontrolled mania or active major depressive disorder

• Previous allergic reaction or side effect to heparin use

• Contraindications to metoclopramide or conditions raising the risk for complication development to metoclopramide, such as hypersensitivity to metoclopramide, ongoing mechanical gastrointestinal obstruction, uncontrolled hypertension, pheochromocytoma, seizure disorders, Parkinson's disease, use of neuroleptics or antipsychotics within 6 months, use of benzodiazepines within the last month, active or recent (last 14 days) use of monoamine oxidase inhibitors or opioids, active alcohol or drug abuse, or other sedatives

• Participation in another study evaluating treatment for impaired awareness of hypoglycemia or hypoglycemia-associated autonomic failure in the last 30 days

• Current use of unblinded real-time Continuous Glucose Monitoring System

• Frequent need of acetaminophen administration