CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Insulin glulisine +1 moredrug
Likely dose
Insulin glulisine 20 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02432716
NCT02432716Phase 1Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Pilot Investigation of the Safety of Intranasal Glulisine in Down Syndrome

HealthPartners Institute·interventional·Posted May 4, 2015·Updated Dec 6, 2019

In Brief

A Phase 1 clinical trial evaluating Insulin glulisine and Saline for Down Syndrome. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 4, 2015
Enrollment StartApr 1, 2015
Primary CompletionOct 18, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.2 years ago

Interventions

Insulin glulisinedrug

Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study

Salinedrug

Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study