Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury (INI-SCI)

March 20, 2026 updated by: HealthPartners Institute

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future.

This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is ≥18 and <85 years of age
  2. Subject has sustained a traumatic or non-traumatic spinal cord injury with American Spinal Injury Association (ASIA) rating A, B, C or D, complete or incomplete
  3. Subject sustained spinal cord injury at least 4 months before baseline visit
  4. Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal / surgically sterile
  5. The subject must be proficient in English in order to comply with instructions and measures for the study
  6. Subject is able to prepare and administer the study drug as outlined in the protocol or has a carer who is available to do so for the duration of the study
  7. Subject can provide written informed consent
  8. Subject has been on a stable regimen of medications for at least 30 days from baseline visit

Exclusion Criteria:

  1. Subject is dependent on a ventilator or has a patent tracheostomy site
  2. Subject has recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a sudden rise in systolic BP greater than 20 mmHg or diastolic BP greater than 10 mmHg without rise in heart rate and accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, or blurry vision
  3. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies
  4. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator
  5. Subject has participated in a clinical trial investigation within 3 months of this study
  6. Subject has a history of allergy, hypersensitivity, or other significant adverse reaction to insulin
  7. Subject is taking insulin for Type I or Type II diabetes
  8. Subject is pregnant or breast feeding
  9. Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal Insulin
Regular Insulin (Novolin-R) 76 international units per day administered as 38 IU in one nostril twice daily (alternating nostrils) for 21+/-3 days
Drug: Regular Insulin
Administered Intranasally at 76 IU
Other Names:
  • Novolin-R
Placebo Comparator: Placebo
0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days
Other: 0.9 % Normal Saline
Placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by number of serious adverse events (SAE) and adverse events (AE)
Time Frame: 3 weeks
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. AEs counts will include total count and will be stratified by severity.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence as assessed by participant Daily Drug Diaries
Time Frame: 3 weeks
Number of doses successfully administered as reported by participants in their daily drug diaries
3 weeks
Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist
Time Frame: Baseline Visit
Average score on virtual training compliance checklist, both arms combined
Baseline Visit
Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey
Time Frame: Baseline
Total score on the Virtual Training Feasibility and Acceptability Survey, both arms combined
Baseline
Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist
Time Frame: Screening Visit
Participants will be trained to perform a blood spot collection procedure independently. Feasibility will be measured by the average score on blood spot procedure compliance checklist, both arms combined
Screening Visit
Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey
Time Frame: Screening Visit
Acceptability of performing blood spot procedure independently will be measured by the average score on a blood spot procedure post-training acceptability survey, both arms combined
Screening Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Uniformed Services University of the Health Sciences
Department of Defense Congressionally Directed Medical Research Program

Investigators

  • Principal Investigator: Leah R Hanson, PhD, HealthPartners Institute
  • Principal Investigator: Kimberly Byrnes, PhD, Uniformed Services University of the Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A22-210-01
  • CDMRP-SC220220 (Other Identifier: Department of Defense Congressionally Directed Medical Research Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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