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Prokinetic Agent

Metoclopramide for Hypoglycemia Unawareness

Phase 2
Recruiting
Led By Simon Fisher, MD, PhD
Research Sponsored by Simon Fisher
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with Type 1 Diabetes Mellitus
Diabetes duration > 5 years
Must not have
Advanced liver disease
Active anemia with hemoglobin less than 11 g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial will test whether the drug metoclopramide can help type 1 diabetes patients who have hypoglycemia unawareness by improving their hypoglycemia awareness and decreasing the incidence of hypoglycemia.

Who is the study for?
This trial is for adults with Type 1 Diabetes Mellitus, who have had diabetes for over 5 years and are experiencing low blood sugar without the usual warning signs. Participants must not be pregnant or breastfeeding, should not have severe heart, liver, or brain conditions, and cannot be on certain medications like antipsychotics or opioids.Check my eligibility
What is being tested?
The study is testing whether Metoclopramide can help people with type 1 diabetes become more aware of when their blood sugar gets too low. It involves comparing Metoclopramide to a placebo (a substance with no active drug) to see if it reduces episodes of low blood sugar.See study design
What are the potential side effects?
Metoclopramide may cause side effects such as fatigue, digestive issues like nausea or constipation, drowsiness, restlessness, and in rare cases might lead to more serious effects like abnormal muscle movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Type 1 Diabetes Mellitus.
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I have had diabetes for more than 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver disease is in an advanced stage.
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My hemoglobin level is below 11 g/dL.
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I have a history of heart issues, including heart attack, irregular heartbeat, heart failure, or poor blood flow in my heart arteries.
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I cannot take metoclopramide due to allergies, certain health conditions, or recent use of specific medications.
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I have had issues with blocked urine flow or not being able to urinate.
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I do not have uncontrolled mania or active major depression.
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I have had a stroke or brain disease in the past.
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I am not pregnant, breastfeeding, and can use effective birth control during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Blood Cortisol
Change in Blood Epinephrine
Change in Blood Glucagon
+3 more
Secondary outcome measures
Ratio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: T1DM - Unaware: MetoclopramideExperimental Treatment1 Intervention
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.
Group II: T1DM - Aware: PlaceboPlacebo Group1 Intervention
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.
Group III: T1DM - Unaware: PlaceboPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Metoclopramide
2016
Completed Phase 4
~29230

Find a Location

Who is running the clinical trial?

Simon FisherLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,066 Total Patients Enrolled
5 Trials studying Hypoglycemia Unawareness
104 Patients Enrolled for Hypoglycemia Unawareness
Simon Fisher, MD, PhDPrincipal Investigator - University of Kentucky
Huntsman Cancer Hospital, University of Utah Neuropsychiatric Institute
University Of Toronto (Medical School)
Beth Israel Deaconess Medical Center (Residency)

Media Library

Metoclopramide (Prokinetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03970720 — Phase 2
Hypoglycemia Unawareness Research Study Groups: T1DM - Aware: Placebo, T1DM - Unaware: Metoclopramide, T1DM - Unaware: Placebo
Hypoglycemia Unawareness Clinical Trial 2023: Metoclopramide Highlights & Side Effects. Trial Name: NCT03970720 — Phase 2
Metoclopramide (Prokinetic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03970720 — Phase 2
~9 spots leftby Mar 2026
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