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Intranasal Insulin and Post-stroke Cognition: A Pilot Study

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ClinicalTrials.gov Identifier: NCT02810392
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Drug: Intranasal Insulin
Drug: Intranasal saline
Enrollment 20
Recruitment Details  
Pre-assignment Details One subject dropped out after signing consent before randomization.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description

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: 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

Period Title: Overall Study
Started 9 10
Completed 8 9
Not Completed 1 1
Reason Not Completed
Subject too ill to continue             1             0
COVID 19 research restrictions             0             1
Arm/Group Title Intranasal Insulin Intranasal Saline Total
Hide Arm/Group Description

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: 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 of all reporting groups
Overall Number of Baseline Participants 9 10 19
Hide Baseline Analysis Population Description
One subject dropped out of study after signing consent before baseline so is not included in baseline analysis.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
50-59 years old
2
  22.2%
0
   0.0%
2
  10.5%
60-69 years old
1
  11.1%
8
  80.0%
9
  47.4%
70-79 years old
5
  55.6%
2
  20.0%
7
  36.8%
80-89 years old
1
  11.1%
0
   0.0%
1
   5.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Female
4
  44.4%
8
  80.0%
12
  63.2%
Male
5
  55.6%
2
  20.0%
7
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Hispanic or Latino
1
  11.1%
0
   0.0%
1
   5.3%
Not Hispanic or Latino
8
  88.9%
10
 100.0%
18
  94.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  11.1%
0
   0.0%
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
8
  88.9%
10
 100.0%
18
  94.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 10 participants 19 participants
9 10 19
1.Primary Outcome
Title Composite of Memory t Scores
Hide Description

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.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
39.5  (7.9) 39.7  (9.9)
2.Primary Outcome
Title Composite of Memory t Scores
Hide Description

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.

Time Frame week 3
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
38.3  (10.8) 34.5  (12.3)
3.Primary Outcome
Title Composite of Memory t Scores
Hide Description

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.

Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
42.4  (7.6) 33.9  (13.0)
4.Primary Outcome
Title Composite of Executive Function t Scores
Hide Description

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.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
28.9  (5.3) 32.6  (6.4)
5.Primary Outcome
Title Composite of Executive Function z Scores
Hide Description

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.

Time Frame week 3
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
29.4  (6.7) 34.4  (6.5)
6.Primary Outcome
Title Composite of Executive Function z Scores
Hide Description

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.

Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
30.7  (5.5) 34.2  (5.9)
7.Primary Outcome
Title Verbal Fluency
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
33.8  (8.0) 36.0  (7.5)
8.Primary Outcome
Title Verbal Fluency
Hide Description 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.
Time Frame week 3
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.0  (8.6) 39.5  (7.5)
9.Primary Outcome
Title Verbal Fluency
Hide Description 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.
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
36.9  (8.3) 39.4  (5.8)
10.Secondary Outcome
Title Montreal Cognitive Assessment (MoCA)
Hide Description 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.
Time Frame Baseline, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 22.4  (3.6) 22.8  (4.9)
week 3 22.0  (3.5) 22.9  (3.3)
week 6 22.1  (2.9) 23.4  (4.2)
11.Secondary Outcome
Title Patient Health Questionnaire-9 Question (PHQ-9)
Hide Description 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.
Time Frame Baseline, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 5.4  (3.5) 4.6  (3.8)
week 3 8.2  (5.4) 4.0  (3.6)
week 6 4.4  (3.4) 3.7  (3.6)
12.Secondary Outcome
Title Story Memory Recall
Hide Description

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.

Time Frame baseline, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 22.5  (11.6) 31.4  (13.6)
week 3 26.1  (11.4) 26.7  (15.7)
week 6 23.9  (12.5) 25.8  (14.5)
13.Other Pre-specified Outcome
Title Instrumental Activities of Daily Living Scale:
Hide Description 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.
Time Frame baseline, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 5.8  (2.4) 6.9  (1.5)
week 3 6.0  (2.4) 7.2  (0.9)
week 6 6.8  (2.0) 6.8  (1.5)
14.Other Pre-specified Outcome
Title Modified Caregiver Strain Index
Hide Description 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.
Time Frame baseline, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 4.7  (3.3) 4.7  (3.7)
week 3 5.2  (3.3) 4.0  (4.8)
week 6 5.5  (3.7) 3.5  (4.0)
15.Other Pre-specified Outcome
Title Modified Rankin Score (MRS)
Hide Description 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.
Time Frame Baseline, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
One subject dropped out after signing consent prior to baseline, so only 19 subjects were randomized and included in the data.
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
baseline 1.7  (1.0) 1.3  (0.8)
week 3 1.2  (0.8) 1.0  (0.9)
week 6 1.5  (1.1) 1.4  (1.2)
Time Frame Adverse event data was collected from baseline through week 9.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intranasal Insulin Intranasal Saline
Hide Arm/Group Description

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: 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

All-Cause Mortality
Intranasal Insulin Intranasal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Intranasal Insulin Intranasal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intranasal Insulin Intranasal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      7/10 (70.00%)    
Cardiac disorders     
Hypertension   1/9 (11.11%)  1 2/10 (20.00%)  2
Ear and labyrinth disorders     
lightheadedness   0/9 (0.00%)  0 1/10 (10.00%)  1
Endocrine disorders     
hypoglycemia   1/9 (11.11%)  1 1/10 (10.00%)  1
hyperglycemia   0/9 (0.00%)  0 2/10 (20.00%)  2
Infections and infestations     
tooth infection   0/9 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
leg cramp   0/9 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders     
worsening of stroke symptoms   0/9 (0.00%)  0 1/10 (10.00%)  1
worsening headache   1/9 (11.11%)  1 1/10 (10.00%)  1
Renal and urinary disorders     
Urinary Tract Infection   0/9 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
hematoma  [1]  1/9 (11.11%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
on arm from mechanical fall
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cheryl Bushnell, MD
Organization: Wake Forest School of Medicine
Phone: 336-713-2983
EMail: cbushnel@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02810392    
Other Study ID Numbers: IRB00029022
First Submitted: February 12, 2016
First Posted: June 23, 2016
Results First Submitted: March 16, 2021
Results First Posted: May 13, 2021
Last Update Posted: May 13, 2021