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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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 - 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.

Group III: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metoclopramide

2016

Completed Phase 4

~29230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Simon FisherLead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,205 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 - Unaware: Placebo, T1DM - Aware: Placebo, T1DM - Unaware: Metoclopramide

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join the research protocol?

"This clinical trial requires a diagnosis of hypoglycemia and an age between 20 to 60 years old. At the moment, 36 applicants are being accepted into this medical study."

Answered by AI

Are there any openings left for participants in this clinical trial?

"According to the information accessible on clinicaltrials.gov, this medical trial is actively seeking participants and has been open since May 28th 2019 with edits made as recently as September 20th 2022."

Answered by AI

What is the aggregate figure of participants enrolled in this clinical trial?

"Indeed, current information on clinicaltrials.gov suggests that this medical trial is in the process of recruiting candidates. Initially posted on May 28th 2019, it was recently updated on September 20th 2022 and requires 36 volunteers at a single location."

Answered by AI

Is the current enrollment in this experiment restricted to individuals over 45 years of age?

"The entrance qualifications for this medical trial stipulate a minimum age of 20 and an upper limit of 60."

Answered by AI

Under what circumstances is Metoclopramide typically recommended?

"Metoclopramide is a well-known therapeutic agent used to treat the aforementioned medical procedure, as well as gastric motility disorder, gastroparesis and other forms of radiologic procedures."

Answered by AI