Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury

NCT07384052 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: A22-210-01CDMRP-SC220220
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

Insulin; Intranasal; Safety; Feasibility; Spinal Cord Injury; SCI; INI

Outcome Measures

Primary Outcomes (1)

• Safety measured by number of serious adverse events (SAE) and adverse events (AE)

  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 Outcomes (5)

• Treatment adherence as assessed by participant Daily Drug Diaries

  3 weeks

• Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist

  Baseline Visit

• Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey

  Baseline

• Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist

  Screening Visit

• Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey

  Screening Visit

Study Arms (2)

Intranasal Insulin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days

Other: 0.9 % Normal Saline

Interventions

Regular Insulin DRUG

Administered Intranasally at 76 IU

Also known as: Novolin-R

Intranasal Insulin

0.9 % Normal Saline OTHER

Placebo Control

Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 and \<85 years of age
• 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
• Subject sustained spinal cord injury at least 4 months before baseline visit
• 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
• The subject must be proficient in English in order to comply with instructions and measures for the study
• 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
• Subject can provide written informed consent
• Subject has been on a stable regimen of medications for at least 30 days from baseline visit

You may not qualify if:

• Subject is dependent on a ventilator or has a patent tracheostomy site
• 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
• 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
• Subject has participated in a clinical trial investigation within 3 months of this study
• Subject has a history of allergy, hypersensitivity, or other significant adverse reaction to insulin
• Subject is taking insulin for Type I or Type II diabetes
• Subject is pregnant or breast feeding
• Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator

Sponsors & Collaborators

• HealthPartners Institute: lead
• Uniformed Services University of the Health Sciences: collaborator
• Department of Defense Congressionally Directed Medical Research Program: collaborator

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Insulin Resistance

Interventions

Insulin; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Leah R Hanson, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Kimberly Byrnes, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan E O'Brien, MPH

CONTACT

651-495-6363; Meghan.E.Obrien@HealthPartners.com

Bethany K Crouse, PhD

CONTACT

Bethany.K.Crouse@HealthPartners.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 into one of 2 groups: 76 IU insulin, or saline (placebo) control

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)