Home › Type 1 Diabetes › NCT03970720
Restoration of Hypoglycemia Awareness With Metoclopramide
RecruitingPhase 2
Who can join
Ages 20 to 60 · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Metoclopramide (drug)
- Placebo (drug)
Sponsor: Simon Fisher · Participants: 36 · Started: May 28, 2019
Contact the study team
- Simon Fisher, MD, PhD · Phone: 859-562-0473
- Karen M Shearer · Phone: 859-323-7778
Official record on ClinicalTrials.gov — NCT03970720
Locations in the U.S.
| Kentucky | University of Kentucky, Lexington |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.