A Phase 1 interventional study of Regular Insulin and 0.9 % Normal Saline in Spinal Cord Injury, sponsored by HealthPartners Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by HealthPartners Institute · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
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
0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days
Other: 0.9 % Normal Saline
Administered Intranasally at 76 IU
Also known as: Novolin-R
Placebo Control
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.
Time frame: 3 weeks
Treatment adherence as assessed by participant Daily Drug Diaries
Number of doses successfully administered as reported by participants in their daily drug diaries
Time frame: 3 weeks
Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist
Average score on virtual training compliance checklist, both arms combined
Time frame: Baseline Visit
Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey
Total score on the Virtual Training Feasibility and Acceptability Survey, both arms combined
Time frame: Baseline
Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist
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
Time frame: Screening Visit
Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey
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
Time frame: Screening Visit
Plan to share: Undecided
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HealthPartners Institute