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Adrenergic Agonist

naloxone for Low Blood Sugar

Phase 2
Waitlist Available
Led By Meredith Hawkins, M.D., M.S.
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Non-diabetic individuals
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 15 minutes at timepoints 0, 15, 30, 45...120 through study completion
Awards & highlights

Summary

This trial is studying how well intensive glucose control works in type 1 diabetes mellitus.

Eligible Conditions
  • Low Blood Sugar
  • Diabetes
  • Autonomic Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every 15 minutes at timepoints 0, 15, 30, 45...120 through study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every 15 minutes at timepoints 0, 15, 30, 45...120 through study completion 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 the counterregulatory responses to hypoglycemia compared to controls
Secondary study objectives
Symptom scores

Side effects data

From 2009 Phase 2 trial • 75 Patients • NCT00330343
54%
Nausea, Vomiting or pruritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1

Trial Design

2Treatment groups
Experimental Treatment
Group I: Type 1 DiabetesExperimental Treatment5 Interventions
T1D individuals will receive drug (naloxone, morphine sulfate, epinephrine) and placebo comparator.
Group II: HealthyExperimental Treatment5 Interventions
Healthy individuals will receive drug (naloxone, morphine sulfate, epinephrine) and placebo comparator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epinephrine
FDA approved
fructose
2015
Completed Phase 2
~110
Morphine
FDA approved
Naloxone
FDA approved
exercise
2014
Completed Phase 4
~1190

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
294 Previous Clinical Trials
11,859,299 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,775 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,395 Total Patients Enrolled
~7 spots leftby Sep 2025
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