Insulin Nasal SpraySafety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury

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