Trial Outcomes & Findings for Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose (NCT NCT05866367)
NCT ID: NCT05866367
Last Updated: 2025-11-18
Results Overview
Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
0-40 minutes post-intranasal administration
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Low dose Intranasal Insulin
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
Baseline characteristics by cohort
| Measure |
Low Dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High Dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Sex/Gender, Customized
Sex assigned at birth · Male
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Sex/Gender, Customized
Sex assigned at birth · Female
|
2 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Study was terminated. No high dose individuals were consented prior to termination.
Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Insulin Concentration Over Time - Cerebrospinal Fluid
40 minutes
|
0 µU/ml
Standard Deviation 0
|
—
|
|
Insulin Concentration Over Time - Cerebrospinal Fluid
0 minutes
|
0.57 µU/ml
Standard Deviation 0.64
|
—
|
|
Insulin Concentration Over Time - Cerebrospinal Fluid
10 minutes
|
0.01 µU/ml
Standard Deviation 0.01
|
—
|
|
Insulin Concentration Over Time - Cerebrospinal Fluid
20 minutes
|
0.02 µU/ml
Standard Deviation 0.03
|
—
|
|
Insulin Concentration Over Time - Cerebrospinal Fluid
30 minutes
|
0.05 µU/ml
Standard Deviation 0.04
|
—
|
PRIMARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Cmax was not summarized as most values were below the limit of detection of the assay.
CSF insulin concentration will also be reported by Cmax (peak concentration)
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Cmax of Insulin Concentration - Cerebrospinal Fluid
|
NA uU/mL
values below LLOQ
|
—
|
PRIMARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Tmax was not calculated as most values were below the limit of detection of the assay.
CSF insulin concentration will also be reported by Tmax (time of peak concentration)
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Tmax of Insulin Concentration - Cerebrospinal Fluid
|
NA minutes
values below LLOQ
|
—
|
PRIMARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: AUC was not calculated as most values were below the limit of detection of the assay.
CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
AUC (Area Under the Curve) of Insulin Concentration - Cerebrospinal Fluid
|
NA uU*min/mL
values below LLOQ
|
—
|
SECONDARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Study was closed. No high dose individuals were consented prior to closure.
Insulin concentration detected in blood at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the blood. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. Serum insulin concentration will also be reported by Cmax (peak concentration), Tmax (time of peak concentration), and AUC (area under the curve, measured as time x concentration).
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Insulin Concentration Over Time - Serum
0 minutes
|
5.8 µU/ml
Standard Deviation 0.85
|
—
|
|
Insulin Concentration Over Time - Serum
10 minute
|
10.8 µU/ml
Standard Deviation 4.8
|
—
|
|
Insulin Concentration Over Time - Serum
20 minutes
|
9.75 µU/ml
Standard Deviation 3.6
|
—
|
|
Insulin Concentration Over Time - Serum
30 minutes
|
9.75 µU/ml
Standard Deviation 5.16
|
—
|
|
Insulin Concentration Over Time - Serum
40 minutes
|
9.95 µU/ml
Standard Deviation 8.88
|
—
|
SECONDARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Study was closed. No high dose individuals were consented prior to closure.
Serum insulin concentration will also be reported by Cmax (peak concentration).
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Cmax of Insulin Concentration - Serum
|
10.85 uU/ml
Standard Deviation 3.35
|
—
|
SECONDARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Study was closed. No high dose individuals were consented prior to closure.
Serum insulin concentration will also be reported by Tmax (time of peak concentration).
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Tmax of Insulin Concentration - Serum
|
10.0 minutes
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: 0-40 minutes post-intranasal administrationPopulation: Study was closed. No high dose individuals were consented prior to closure.
Serum insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
Outcome measures
| Measure |
Low dose Intranasal Insulin
n=2 Participants
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
AUC (Area Under the Curve) of Insulin Concentration - Serum
|
382.25 uU*min/ml
Standard Deviation 115.75
|
—
|
Adverse Events
Low dose Intranasal Insulin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
High dose Intranasal Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low dose Intranasal Insulin
n=2 participants at risk
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Ear and labyrinth disorders
Positional Headache
|
50.0%
1/2 • Number of events 1 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
Other adverse events
| Measure |
Low dose Intranasal Insulin
n=2 participants at risk
One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
Low dose Regular Insulin: Regular insulin administered intranasally at either 40 IU
|
High dose Intranasal Insulin
One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
High dose Regular insulin: Regular insulin administered intranasally at either 80 IU
|
|---|---|---|
|
Eye disorders
Watery eyes
|
50.0%
1/2 • Number of events 1 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
|
Ear and labyrinth disorders
Lightheadedness
|
100.0%
2/2 • Number of events 2 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
50.0%
1/2 • Number of events 1 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
|
Ear and labyrinth disorders
Ear infection
|
50.0%
1/2 • Number of events 1 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
|
General disorders
Pain at needle insertion
|
50.0%
1/2 • Number of events 2 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
—
0/0 • 4 months
Study was terminated. No high dose individuals were consented prior to termination.
|
Additional Information
Clinical Research Coordinator
HealthPartners Institute Neuroscience Research
Phone: 651-495-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place