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NCT02700048 · ClinicalTrials.gov registry record · Phase 1

Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

A Phase 1 study, sponsored by University of Minnesota.

Terminated
Registry status
Phase 1
Development phase
11
Enrollment target

NCT02700048: Clinical Trial Phase 1 study, sponsored by University of Minnesota.

NCT02700048 is a Phase 1 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02700048, a Phase 1 study, was terminated before completion, sponsored by University of Minnesota.

TERMINATED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Primary endpoint will be the within person difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two; investigators will compare this difference between the two treatment conditions

Interventions

  • DRUG intra-nasal naloxone
  • DRUG Intra-nasal saline

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2016-06
Est. Completion 2021-07
Phase Phase 1
University of Minnesota

966 total trials

Why NCT02700048 stopped before completion

NCT02700048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which intra-nasal naloxone is the first listed.

NCT02700048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02700048 about?

NCT02700048 is a clinical study titled "Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia". 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 indi...

What is the current status of trial NCT02700048?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-06. Estimated completion is 2021-07.

What interventions are being tested in trial NCT02700048?

The interventions under investigation include: intra-nasal naloxone (DRUG), Intra-nasal saline (DRUG).

Who is sponsoring clinical trial NCT02700048?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02700048's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02700048, the US trial registry maintained by the National Library of Medicine. NCT02700048 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.