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Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

NCT02700048 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-03-27

Study results available
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Summary

This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators intend to enroll 18 individuals to obtain the complete data sets from 15 participants. Expected duration of subject participation is 10-12 weeks. This study will consist of two 2-day intervention visits separated by approximately 8 weeks.

Conditions

Interventions

DRUG

intra-nasal naloxone

3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps

DRUG

Intra-nasal saline

3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps

Sponsors & Collaborators

Principal Investigators

  • Amir Moheet, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700048 on ClinicalTrials.gov