Testing metoclopramide to help restore low blood sugar awareness in type 1 diabetes
Tests metoclopramide against placebo in adults with type 1 diabetes and hypoglycemia unawareness.
Key facts
- Who runs it
- Simon Fisher
- Where
- Lexington and Salt Lake City, United StatesSee the 2 sites
- Trial code
- Registry title
- Restoration of Hypoglycemia Awareness With Metoclopramide
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 36 people, planned
- Started
- 28 May 2019
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Metoclopramide
- Placebo
- Record updated
- 20 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes who do not notice when their blood sugar drops too low. It tests whether metoclopramide can help them notice it.
- Age
- 20 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes for more than 5 years. Hemoglobin A1c of 9% (75 mmol/mol) or lower.
- Earlier treatment
- Cannot join: use of neuroleptics or antipsychotics within 6 months, benzodiazepines within the last month, or monoamine oxidase inhibitors or opioids in the last 14 days.
Main reasons for not taking part
- History of heart attack, irregular heartbeat, heart failure or coronary artery insufficiency
- History of stroke or brain disease
- Advanced liver disease or active anemia with hemoglobin less than 11 g/dL
- Pregnant or breastfeeding, or unable to use effective contraception during the study
- Contraindication to metoclopramide, such as seizure disorders, Parkinson's disease or uncontrolled hypertension
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous allergic reaction or side effect to heparin use
- 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
- Active anemia with hemoglobin less than 11 g/dL
- Current use of unblinded real-time Continuous Glucose Monitoring System
- Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period
- Frequent need of acetaminophen administration
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 60 years old?
Where in United States
- University of KentuckyLexington, United StatesContact: Simon Fisher, MD, PhDTaking people
- University of UtahSalt Lake City, United StatesContact: Simon Fisher, MD, PhDNo longer taking part
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- T1DM - Unaware: MetoclopramideTreatment being tested
T1DM participants with hypoglycemia unawareness determined by a hypoglycemic clamp study will receive 10 mg metoclopramide four times a day during the four-week intervention period.
Treatment: Metoclopramide
- T1DM - Unaware: PlaceboPlacebo, for comparison
T1DM participants with hypoglycemia unawareness determined by a hypoglycemic clamp study will receive 10 mg matching placebo capsules four times a day during the four-week intervention period.
Treatment: Placebo
- T1DM - Aware: PlaceboPlacebo, for comparison
T1DM participants with hypoglycemia awareness determined by a hypoglycemic clamp study will receive 10 mg matching placebo capsules four times a day during the four-week intervention period.
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Restoration of Hypoglycemia Awareness With Metoclopramide
- Plain-language title
- Testing metoclopramide to help restore low blood sugar awareness in type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT03970720, who can take part
- Record updated
- 20 March 2026