Trial Outcomes & Findings for Intranasal Insulin and Post-stroke Cognition: A Pilot Study (NCT NCT02810392)
NCT ID: NCT02810392
Last Updated: 2021-05-13
Results Overview
These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome.
COMPLETED
PHASE2
20 participants
week 3
2021-05-13
Participant Flow
One subject dropped out after signing consent before randomization.
Participant milestones
| Measure |
Intranasal Insulin
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Intranasal Insulin
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Overall Study
Subject too ill to continue
|
1
|
0
|
|
Overall Study
COVID 19 research restrictions
|
0
|
1
|
Baseline Characteristics
Intranasal Insulin and Post-stroke Cognition: A Pilot Study
Baseline characteristics by cohort
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-59 years old
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
80-89 years old
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Hopkins Verbal Learning Test-Revised (HVLT-R) verbal learning and memory and available to facilitate repeat administration in future testing (10 minutes with delay and recognition). The delayed recall is used as the outcome in this study. Brief Visual Memory Test-Revised (BVMT-R) is a measure of nonverbal learning and memory captured with immediate and delayed free recall trials, and a recognition memory task (10 minutes with delay and recognition). The retained score normalized by age, is used as the outcome for this study. The t scores for both HVLT-R delayed recall and BVMT-R retained are normalized from the raw scores based on age. The t score ranges from 0-100 with 0 denoting a worse outcome. The Composite is the average of the mean t scores for each component.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Composite of Memory t Scores
|
39.5 score on a scale
Standard Deviation 7.9
|
39.7 score on a scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: week 3Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Hopkins Verbal Learning Test-Revised (HVLT-R) verbal learning and memory and available to facilitate repeat administration in future testing (10 minutes with delay and recognition). The delayed recall is used as the outcome in this study. Brief Visual Memory Test-Revised (BVMT-R) is a measure of nonverbal learning and memory captured with immediate and delayed free recall trials, and a recognition memory task (10 minutes with delay and recognition). The retained score is used as the outcome for this study. The t scores for both HVLT-R delayed recall and BVMT-R retained are normalized from the raw scores based on age. The t score ranges from 0-100 with 0 denoting a worse outcome. The Composite is the average of the mean t scores for each component.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Composite of Memory t Scores
|
38.3 score on a scale
Standard Deviation 10.8
|
34.5 score on a scale
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Hopkins Verbal Learning Test-Revised (HVLT-R) verbal learning and memory and available to facilitate repeat administration in future testing (10 minutes with delay and recognition). The delayed recall is used as the outcome in this study. Brief Visual Memory Test-Revised (BVMT-R) is a measure of nonverbal learning and memory captured with immediate and delayed free recall trials, and a recognition memory task (10 minutes with delay and recognition). The retained score is used as the outcome for this study. The t scores for both HVLT-R delayed recall and BVMT-R retained are normalized from the raw scores based on age. The t score ranges from 0-100 with 0 denoting a worse outcome. The Composite is the average of the mean t scores for each component.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Composite of Memory t Scores
|
42.4 score on a scale
Standard Deviation 7.6
|
33.9 score on a scale
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: baselinePopulation: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
The Trail Making test-B is a test of sequencing between numbers and letters, and the score is the amount of time needed to complete the test. The t score is the raw score for time to completion and errors, normalized by age and education, and ranges from 0 (poor performance) to 100 (good performance). WAIS Digit Span subtest Reverse is a measure of working memory, and requires repetition of increasingly longer strings of digits in the reverse order. The t scores are raw scores normalized by age and range from 0 to 100. WAIS-III Digit-Symbol Coding is a measure of visuomotor processing speed, and requires involves rapidly coding geometric symbols given a number, by using a legend of number-symbol pairs at the top of the page. T scores are raw scores normalized by age, and range from 0 to 100. The composite outcome included average of the mean t scores for Trailmaking B, Digit span reverse, and digit-symbol coding.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Composite of Executive Function t Scores
|
28.9 score on a scale
Standard Deviation 5.3
|
32.6 score on a scale
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: week 3Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
The Trail Making test-B is a test of sequencing between numbers and letters, and the score is the amount of time needed to complete the test. The t score is the raw score for time to completion and errors, normalized by age and education, and ranges from 0 (poor performance) to 100 (good performance). WAIS Digit Span subtest Reverse is a measure of working memory, and requires repetition of increasingly longer strings of digits in the reverse order. The t scores are raw scores normalized by age and range from 0 to 100. WAIS-III Digit-Symbol Coding is a measure of visuomotor processing speed, and requires involves rapidly coding geometric symbols given a number, by using a legend of number-symbol pairs at the top of the page. T scores are raw scores normalized by age, and range from 0 to 100. The composite outcome included average of the mean t scores for Trailmaking B, Digit span reverse, and digit-symbol coding.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Composite of Executive Function z Scores
|
29.4 score on a scale
Standard Deviation 6.7
|
34.4 score on a scale
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
The Trail Making test-B is a test of sequencing between numbers and letters, and the score is the amount of time needed to complete the test. The t score is the raw score for time to completion and errors, normalized by age and education, and ranges from 0 (poor performance) to 100 (good performance). WAIS Digit Span subtest Reverse is a measure of working memory, and requires repetition of increasingly longer strings of digits in the reverse order. The t scores are raw scores normalized by age and range from 0 to 100. WAIS-III Digit-Symbol Coding is a measure of visuomotor processing speed, and requires involves rapidly coding geometric symbols given a number, by using a legend of number-symbol pairs at the top of the page. T scores are raw scores normalized by age, and range from 0 to 100. The composite outcome included average of the mean t scores for Trailmaking B, Digit span reverse, and digit-symbol coding.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Composite of Executive Function z Scores
|
30.7 score on a scale
Standard Deviation 5.5
|
34.2 score on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: baselinePopulation: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Verbal Fluency
|
33.8 score on a scale
Standard Deviation 8.0
|
36.0 score on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: week 3Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Verbal Fluency
|
34.0 score on a scale
Standard Deviation 8.6
|
39.5 score on a scale
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
These tasks of verbal fluency provide the subject one minute to say as many words as possible. For Animal Naming, any living creature is counted. For FAS, words beginning with a given letter (F, A, and then S) are counted excluding proper nouns, numbers, and variations of the same word. Raw scores are converted to t scores, normalized by age, and range from 0 (worse) to 100 (better) outcome.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Verbal Fluency
|
36.9 score on a scale
Standard Deviation 8.3
|
39.4 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline, week 3, week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
The MoCA is a cognitive screening instrument which provides information about overall mental status. It is useful for identifying overall cognitive impairment, and also provides information about core cognitive domains, such as visuospatial abilities, attention, executive function, language, orientation, and memory. Score ranges from 0-30 with scores of 26-30 denoting no cognitive impairment, 21-25 mild cognitive impairment and 20 or lower, dementia or severe cognitive impairment.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
baseline
|
22.4 score on a scale
Standard Deviation 3.6
|
22.8 score on a scale
Standard Deviation 4.9
|
|
Montreal Cognitive Assessment (MoCA)
week 6
|
22.1 score on a scale
Standard Deviation 2.9
|
23.4 score on a scale
Standard Deviation 4.2
|
|
Montreal Cognitive Assessment (MoCA)
week 3
|
22.0 score on a scale
Standard Deviation 3.5
|
22.9 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, week 3, week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
The PHQ-9 is a measure of depression and is comprised of 9 questions with likert scale responses related to how frequent depressive symptoms are occurring. The likert score for each question is totaled for the final score, which ranges from 0-27 with a score of 27 denoting a higher severity of depression.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Patient Health Questionnaire-9 Question (PHQ-9)
week 3
|
8.2 score on a scale
Standard Deviation 5.4
|
4.0 score on a scale
Standard Deviation 3.6
|
|
Patient Health Questionnaire-9 Question (PHQ-9)
baseline
|
5.4 score on a scale
Standard Deviation 3.5
|
4.6 score on a scale
Standard Deviation 3.8
|
|
Patient Health Questionnaire-9 Question (PHQ-9)
week 6
|
4.4 score on a scale
Standard Deviation 3.4
|
3.7 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: baseline, week 3, week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
A narrative of 44 informational bits is read and the recalled information is recorded immediately and after 20 minutes. Information retained over the delay are calculated as delayed recall/ immediate recall. The participant is asked to recite it immediately, and then following a 20-minute delay. Delayed score (the outcome analyzed here) ranges from 0 to 44 with a higher score denoting a better ability to recall information.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Story Memory Recall
baseline
|
22.5 score on a scale
Standard Deviation 11.6
|
31.4 score on a scale
Standard Deviation 13.6
|
|
Story Memory Recall
week 3
|
26.1 score on a scale
Standard Deviation 11.4
|
26.7 score on a scale
Standard Deviation 15.7
|
|
Story Memory Recall
week 6
|
23.9 score on a scale
Standard Deviation 12.5
|
25.8 score on a scale
Standard Deviation 14.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, week 3, week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Lawton Instrumental ADL scale includes 8 domains related to higher level function, including using a telephone, handling money, ability to take medications correctly, independence with transportation, food preparation, shopping, laundry, and housekeeping. Score ranges from 0-8 with 0 denoting no independence with IADLs, and 8 the highest level of independence with IADLs.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Instrumental Activities of Daily Living Scale:
baseline
|
5.8 score on a scale
Standard Deviation 2.4
|
6.9 score on a scale
Standard Deviation 1.5
|
|
Instrumental Activities of Daily Living Scale:
week 3
|
6.0 score on a scale
Standard Deviation 2.4
|
7.2 score on a scale
Standard Deviation 0.9
|
|
Instrumental Activities of Daily Living Scale:
week 6
|
6.8 score on a scale
Standard Deviation 2.0
|
6.8 score on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, week 3, week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
13 questions related to caregiver strain, administered to caregivers separately from the stroke survivor. Score ranges from 0-13 with a score of 7 or more indicating significant caregiver strain.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Modified Caregiver Strain Index
baseline
|
4.7 score on a scale
Standard Deviation 3.3
|
4.7 score on a scale
Standard Deviation 3.7
|
|
Modified Caregiver Strain Index
week 3
|
5.2 score on a scale
Standard Deviation 3.3
|
4.0 score on a scale
Standard Deviation 4.8
|
|
Modified Caregiver Strain Index
week 6
|
5.5 score on a scale
Standard Deviation 3.7
|
3.5 score on a scale
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 3, week 6Population: One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
The mRS Score is a score for disability after stroke. A score of 0 indicates no symptoms remaining and normal pre-stroke activity, 1 indicates no disability despite symptoms, 2 indicates mild disability but still independent, 3 indicates moderate disability but able to walk, 4 indicates moderate to severe disability and requiring significant help from others, 5 indicates 24 hour nursing care and complete dependence on others, and 6 is death.
Outcome measures
| Measure |
Intranasal Insulin
n=9 Participants
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 Participants
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Modified Rankin Score (MRS)
baseline
|
1.7 score on a scale
Standard Deviation 1.0
|
1.3 score on a scale
Standard Deviation 0.8
|
|
Modified Rankin Score (MRS)
week 3
|
1.2 score on a scale
Standard Deviation 0.8
|
1.0 score on a scale
Standard Deviation 0.9
|
|
Modified Rankin Score (MRS)
week 6
|
1.5 score on a scale
Standard Deviation 1.1
|
1.4 score on a scale
Standard Deviation 1.2
|
Adverse Events
Intranasal Insulin
Intranasal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Insulin
n=9 participants at risk
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal Insulin: Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
|
Intranasal Saline
n=10 participants at risk
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Delivery is with the Vianase device, 0.5 cc of normal saline
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
20.0%
2/10 • Number of events 2 • Adverse event data was collected from baseline through week 9.
|
|
Nervous system disorders
worsening of stroke symptoms
|
0.00%
0/9 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
|
Endocrine disorders
hypoglycemia
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
|
Endocrine disorders
hyperglycemia
|
0.00%
0/9 • Adverse event data was collected from baseline through week 9.
|
20.0%
2/10 • Number of events 2 • Adverse event data was collected from baseline through week 9.
|
|
Nervous system disorders
worsening headache
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
|
Ear and labyrinth disorders
lightheadedness
|
0.00%
0/9 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
|
Vascular disorders
hematoma
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
0.00%
0/10 • Adverse event data was collected from baseline through week 9.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/9 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
|
Infections and infestations
tooth infection
|
0.00%
0/9 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
|
Musculoskeletal and connective tissue disorders
leg cramp
|
0.00%
0/9 • Adverse event data was collected from baseline through week 9.
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected from baseline through week 9.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place