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Metoclopramide for Hypoglycemia Unawareness in Type 1 Diabetes

This study is looking at whether a drug called metoclopramide can help people with Type 1 diabetes who have trouble recognizing when their blood sugar is low (hypoglycemia unawareness). Metoclopramide is already approved for other stomach issues. Researchers want to see if taking 10 mg of metoclopramide four times a day, compared to a placebo (an inactive pill), can improve how your body responds to low blood sugar. They will measure changes in hormones like glucagon, epinephrine, and norepinephrine after 4 weeks. You might be able to join if you are 20-60 years old, have had Type 1 diabetes for over 5 years, and your A1c is 9% or less. The study plans to enroll 36 people, but its current status is unclear.

Study design
This study is an interventional study, meaning participants will receive either metoclopramide or a placebo. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken at 4 weeks.

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NCT03970720

Restoration of Hypoglycemia Awareness With Metoclopramide

Recruiting
PHASE2Ages 20–60InterventionalTreatment
Simon Fisher
~36 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:MetoclopramidePlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Blood Glucagon
Measured over 4 weeks
+5 more outcomes measured

Conditions

Hypoglycemia Unawareness

Explore related trials

Loss of hypoglycemic warning due to diabetes mellitusType 1 Diabetes Mellitus

Where it's being run

2 sites across 2 states
Kentucky1
Utah1

Study leadership

  • Simon Fisher, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Simon Fisher, MD, PhD
[email protected]
859-562-0473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Blood Glucagon4 weeks

    Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood glucagon level will be compared between the study arms.

  • Change in Blood Epinephrine4 weeks

    Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood epinephrine level will be compared between the study arms.

  • Change in Blood Norepinephrine4 weeks

    Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood norepinephrine level will be compared between the study arms.

  • Change in Blood Cortisol4 weeks

    Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood cortisol level will be compared between the study arms.

  • Change in Blood Pancreatic Polypeptide4 weeks

    Blood samples will be drawn from study participants during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period. The average change in blood pancreatic polypeptide level will be compared between the study arms.

  • Change in Hypoglycemia Symptom Recognition4 weeks

    Participant's self-reported symptoms of hypoglycemia will be obtained during the initial hypoglycemic clamp study (Day 0) and during the second hypoglycemic clamp study (Day 28) following the 4-week intervention period.