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NCT02432716 · ClinicalTrials.gov registry record · Phase 1

Investigation of the Safety of Intranasal Glulisine in Down Syndrome

A Phase 1 study, sponsored by HealthPartners Institute.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT02432716: Completed Phase 1 study, sponsored by HealthPartners Institute.

NCT02432716 is a Phase 1 study that has completed, run by HealthPartners Institute. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02432716, a Phase 1 study, has completed, sponsored by HealthPartners Institute.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo in patients with DS. Subjects will be randomized into this cross-over study and within subject comparisons conducted between single treatment of intranasal insulin glulisine and single treatment of intranasal placebo. All subjects will also receive a single treatment of placebo prior to randomization to ensure adherence to study procedures.

Primary Outcome

Number of adverse and/or serious events

Interventions

  • DRUG Saline
  • DRUG Insulin glulisine

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2015-04
Est. Completion 2018-10-18
Phase Phase 1
HealthPartners Institute

146 total trials

What the finished NCT02432716 record still lists

NCT02432716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

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

NCT02432716 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02432716 about?

NCT02432716 is a clinical study titled "Investigation of the Safety of Intranasal Glulisine in Down Syndrome". This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo in patients with DS. Subjects will be randomized into this cross-over study and within subject comparisons conduct...

What is the current status of trial NCT02432716?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-04. Estimated completion is 2018-10-18.

What interventions are being tested in trial NCT02432716?

The interventions under investigation include: Saline (DRUG), Insulin glulisine (DRUG).

Who is sponsoring clinical trial NCT02432716?

This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02432716's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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 NCT02432716, the US trial registry maintained by the National Library of Medicine. NCT02432716 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.