NCT02432716

Investigation of the Safety of Intranasal Glulisine in Down Syndrome

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DRUG	Insulin glulisine	Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study
DRUG	Saline	Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-10-18
• Completion: 2018-10-18
• First posted: 2015-05-04
• Last updated: 2019-12-06
• Results posted: 2019-12-06

Locations

1 site across 1 country: United States