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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the counterregulatory responses to hypoglycemia compared to controls
Secondary outcome measures
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
286 Previous Clinical Trials
11,856,449 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,352 Previous Clinical Trials
4,315,026 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,690 Previous Clinical Trials
6,950,892 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mechanisms of Hypoglycemia Associated Autonomic Failure
Meredith Hawkins 2008. "Mechanisms of Hypoglycemia Associated Autonomic Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00678145.
All > Hypoglycemia
~7 spots leftby Apr 2025
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