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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

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Blood Cortisol

Change in Blood Epinephrine

Change in Blood Glucagon

+3 more

Secondary study objectives

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

0 / 10Eligibility criteria met