NCT03970720RecruitingPhase 2
Restoration of Hypoglycemia Awareness With Metoclopramide
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 29 May 2019
- Start date
- 28 May 2019
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Simon Fisher
- Diseases
- Type 1 diabetes
- NCT number
- NCT03970720
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 28 May 2019 to the primary completion date, 30 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allergic reaction or side effect to heparin use
Other illness
- 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
- Uncontrolled mania or active major depressive disorder
- 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
Lab values
- Active anemia with hemoglobin less than 11 g/dL
- Current use of unblinded real-time Continuous Glucose Monitoring System
Other
- Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period
- Frequent need of acetaminophen administration
Who the study is looking for
- 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
Age in the registry: 20 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.