NCT02432716 is a Phase 1 clinical trial of Insulin glulisine in Down Syndrome, sponsored by HealthPartners Institute.

Who is sponsoring NCT02432716?

NCT02432716 is sponsored by HealthPartners Institute.

What drugs are being tested in NCT02432716?

Interventions in NCT02432716: Insulin glulisine, Saline.

What condition does NCT02432716 study?

NCT02432716 studies Down Syndrome.

Is NCT02432716 still recruiting?

NCT02432716 is currently completed. Last updated 19 November 2019.

Are results published for NCT02432716?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-19 · How we verify

NCT02432716

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 19 November 2019

What this trial tests

Phase 1 trial testing Insulin glulisine in Down Syndrome in 12 participants. Completed in 18 October 2018.

Timeline

1 April 2015

Primary endpoint
18 October 2018

18 October 2018

Quick facts

Lead sponsor	HealthPartners Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	1 April 2015
Primary completion	18 October 2018
Estimated completion	18 October 2018
Sites	1 location across United States

Drugs / interventions tested

Insulin glulisine (INSULIN GLULISINE) — full drug profile →
Saline

Conditions studied

Down Syndrome — all drugs for Down Syndrome →

Sponsor

HealthPartners Institute

Who can join

Adults 35 to 80, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety Measured by Adverse Events
Time frame: 1 year
Number of adverse and/or serious events

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Aging with Down Syndrome-Where Are We Now and Where Are We Going?
Alldred MJ, Martini AC, Patterson D, Hendrix J, et al · · 2021 · cited 29× · PMID 34682809 · DOI 10.3390/jcm10204687
Dose imbalance of DYRK1A kinase causes systemic progeroid status in Down syndrome by increasing the un-repaired DNA damage and reducing LaminB1 levels.
Murray A, Gough G, Cindrić A, Vučković F, et al · · 2023 · cited 27× · PMID 37451904 · DOI 10.1016/j.ebiom.2023.104692
Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome.
Rosenbloom M, Barclay T, Johnsen J, Erickson L, et al · · 2020 · cited 8× · PMID 32077057 · DOI 10.1007/s40268-020-00296-2

Verify or expand the search:

Other trials of Insulin glulisine

Trials testing the same drug.

NCT02910518 — A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutane · Phase 1 · completed
NCT02503501 — Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease · Phase 2 · terminated

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

NCT07416201 — Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy · recruiting
NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting

Other HealthPartners Institute trials

Trials by the same sponsor.

NCT07127133 — An Insole and Ankle Device for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzhei · NA · not yet recruiting
NCT07354919 — Axelopran in Advanced Cancers · Phase 2 · not yet recruiting
NCT06434038 — Measurement of Insulin Levels in the Cerebrospinal Fluid of Healthy Adults After a Single Intranasal Dose - Middle Age · Phase 1 · withdrawn
NCT06914726 — Patient Centered Clinical Decision Support for Hereditary Cancer Syndromes · NA · enrolling by invitation
NCT06999330 — TMS in Anxiety-Parkinson's Disease · NA · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02432716 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HealthPartners Institute
Last refreshed: 19 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02432716.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing