Trial Outcomes & Findings for Memory Aid by Intranasal Insulin in Diabetes (MemAID) (NCT NCT02415556)
NCT ID: NCT02415556
Last Updated: 2022-05-19
Results Overview
Gait speed normal walk (cm/s) - difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
289 participants
Primary outcome timeframe
Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).
Results posted on
2022-05-19
Participant Flow
Participants were recruited at two hospital sites. The study was activated by IRB on 4/1/42015. The first participant was enrolled (signed ICF) at BIDMC on 10/6/2015 and at BWH 6/22/2017 and the last participant was enrolled in December 2019.
Of 668 screened participants, 289 signed ICF( enrolled), 244 were randomized to INI or placebo treatment, 223 completed baseline and were analyzed.
Participant milestones
| Measure |
Type 2 Diabetes Mellitus - Insulin
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
58
|
65
|
64
|
|
Overall Study
COMPLETED
|
32
|
37
|
43
|
44
|
|
Overall Study
NOT COMPLETED
|
25
|
21
|
22
|
20
|
Reasons for withdrawal
| Measure |
Type 2 Diabetes Mellitus - Insulin
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
14
|
12
|
|
Overall Study
Physician Decision
|
1
|
3
|
1
|
2
|
|
Overall Study
Censored - study completion
|
4
|
5
|
1
|
0
|
|
Overall Study
Family-related issues
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Memory Aid by Intranasal Insulin in Diabetes (MemAID)
Baseline characteristics by cohort
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
65.4 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
55 participants
n=7 Participants
|
58 participants
n=5 Participants
|
59 participants
n=4 Participants
|
223 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).Population: Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.
Gait speed normal walk (cm/s) - difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Gait Speed Normal Walk (cm/s).
Baseline
|
112.23 cm/s
Standard Deviation 22.94
|
103.42 cm/s
Standard Deviation 21.04
|
121.58 cm/s
Standard Deviation 21.87
|
119.51 cm/s
Standard Deviation 15.61
|
|
Gait Speed Normal Walk (cm/s).
On-treatment average
|
112.43 cm/s
Standard Deviation 22.03
|
105.83 cm/s
Standard Deviation 21.27
|
123.89 cm/s
Standard Deviation 23.36
|
119.44 cm/s
Standard Deviation 18.60
|
|
Gait Speed Normal Walk (cm/s).
Post-treatment average
|
113.12 cm/s
Standard Deviation 19.60
|
107.27 cm/s
Standard Deviation 23.16
|
124.79 cm/s
Standard Deviation 24.75
|
120.50 cm/s
Standard Deviation 19.33
|
PRIMARY outcome
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).Population: Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.
Gait speed dual-task (cm/s) - walking and counting backwards (subtracting 7) difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Gait Speed Dual-task (cm/s).
Baseline
|
104.23 cm/s
Standard Deviation 23.30
|
93.18 cm/s
Standard Deviation 22.71
|
109.44 cm/s
Standard Deviation 24.40
|
110.24 cm/s
Standard Deviation 16.50
|
|
Gait Speed Dual-task (cm/s).
On-treatment average
|
105.34 cm/s
Standard Deviation 23.59
|
98.27 cm/s
Standard Deviation 22.39
|
114.66 cm/s
Standard Deviation 25.11
|
112.58 cm/s
Standard Deviation 17.99
|
|
Gait Speed Dual-task (cm/s).
Post-treatment average
|
108.77 cm/s
Standard Deviation 20.49
|
102.22 cm/s
Standard Deviation 21.02
|
117.29 cm/s
Standard Deviation 26.73
|
113.08 cm/s
Standard Deviation 20.60
|
PRIMARY outcome
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).Population: Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.
The executive function composite score was calculated as a sum of Paired Associates Learning (PAL) and Spatial Working Memory (SWM) z-scores (range -2 to +2, 0 indicates the mean; higher score indicates worse outcome). Paired Associates Learning - raw score of Total Errors Adjusted (range 0-120) was converted to z-score. Spatial Working Memory - raw score SWM-Between Errors (range 0-42) and raw score of SWM-Strategy (range 8-56) were converted to z-scores. Executive function composite scores were compared between: Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Executive Function Composite z Score
Baseline
|
0.84 units on a scale
Standard Deviation 2.08
|
1.40 units on a scale
Standard Deviation 2.30
|
0.46 units on a scale
Standard Deviation 2.25
|
0.66 units on a scale
Standard Deviation 2.22
|
|
Executive Function Composite z Score
On-treatment average
|
0.13 units on a scale
Standard Deviation 2.11
|
0.47 units on a scale
Standard Deviation 2.48
|
-0.51 units on a scale
Standard Deviation 2.56
|
0.14 units on a scale
Standard Deviation 2.34
|
|
Executive Function Composite z Score
Post-treatment average
|
-0.19 units on a scale
Standard Deviation 2.16
|
-0.11 units on a scale
Standard Deviation 2.44
|
-1.08 units on a scale
Standard Deviation 2.38
|
-0.31 units on a scale
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).Population: Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.
Verbal memory composite score was calculated as the sum of Verbal Recognition Memory (VRM) z scores ( 0 indicates the mean; lower score indicates worse outcome). VRM- Free Recall raw score (range 0-12), immediate and delayed VRM-Recognition raw score (range 0-24) were converted to z-scores. Verbal memory composite scores were compared between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Verbal Memory Composite z Score
Baseline
|
-0.74 score on a scale
Standard Deviation 2.72
|
-0.89 score on a scale
Standard Deviation 3.02
|
0.07 score on a scale
Standard Deviation 2.69
|
-0.22 score on a scale
Standard Deviation 2.33
|
|
Verbal Memory Composite z Score
On-treatment average
|
-0.16 score on a scale
Standard Deviation 2.31
|
-0.50 score on a scale
Standard Deviation 2.20
|
0.34 score on a scale
Standard Deviation 2.16
|
-0.01 score on a scale
Standard Deviation 2.34
|
|
Verbal Memory Composite z Score
Post-treatment average
|
0.05 score on a scale
Standard Deviation 2.21
|
-0.24 score on a scale
Standard Deviation 1.98
|
1.01 score on a scale
Standard Deviation 1.82
|
0.23 score on a scale
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).Population: Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.
Long-term safety measure of fasting plasma glucose difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Fasting Plasma Glucose (mg/dL).
Baseline
|
138.63 mg/dL
Standard Deviation 44.60
|
141.25 mg/dL
Standard Deviation 51.15
|
92.07 mg/dL
Standard Deviation 7.72
|
90.54 mg/dL
Standard Deviation 7.71
|
|
Fasting Plasma Glucose (mg/dL).
On-treatment average
|
140.47 mg/dL
Standard Deviation 44.71
|
132.18 mg/dL
Standard Deviation 39.45
|
90.11 mg/dL
Standard Deviation 7.97
|
89.61 mg/dL
Standard Deviation 9.33
|
|
Fasting Plasma Glucose (mg/dL).
Post-treatment average
|
143.28 mg/dL
Standard Deviation 51.69
|
140.34 mg/dL
Standard Deviation 42.49
|
90.05 mg/dL
Standard Deviation 7.62
|
91.94 mg/dL
Standard Deviation 12.56
|
SECONDARY outcome
Timeframe: Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).Population: Intention-to-treat analyses (Model 1) included data from 223 randomized subjects who completed the baseline visit.
Long-term safety measure of weight difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Weight (kg).
Baseline
|
90.36 kg
Standard Deviation 21.80
|
90.96 kg
Standard Deviation 20.03
|
75.89 kg
Standard Deviation 14.19
|
76.40 kg
Standard Deviation 17.76
|
|
Weight (kg).
On-treatment average
|
88.44 kg
Standard Deviation 19.75
|
93.79 kg
Standard Deviation 18.50
|
75.97 kg
Standard Deviation 13.43
|
77.14 kg
Standard Deviation 18.34
|
|
Weight (kg).
Post-treatment average
|
90.41 kg
Standard Deviation 19.82
|
92.59 kg
Standard Deviation 19.23
|
76.15 kg
Standard Deviation 13.58
|
78.18 kg
Standard Deviation 19.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline and at V8 (week 24) the last intervention.Population: MRI at 3 Tesla performed in 8 Type 2 Diabetes Mellitus - Insulin participants and 3 Type 2 Diabetes Mellitus - Placebo participants only.
Difference in regional cerebral blood flow in right medial prefrontal cortex (MPFC) was measured by pseudo-continuous arterial spin labeling (PCASL) MRI at 3 Tesla in 8 Type 2 Diabetes Mellitus - Insulin participants and 3 Type 2 Diabetes Mellitus - Placebo participants only.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=8 Participants
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=3 Participants
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Cerebral Blood Flow on Magnetic Resonance Imaging (MRI).
End of treatment
|
92.68 50ml/100g/min
Standard Deviation 6.77
|
92.73 50ml/100g/min
Standard Deviation 0.98
|
—
|
—
|
|
Cerebral Blood Flow on Magnetic Resonance Imaging (MRI).
Baseline
|
86.40 50ml/100g/min
Standard Deviation 6.71
|
95.23 50ml/100g/min
Standard Deviation 0.52
|
—
|
—
|
Adverse Events
Type 2 Diabetes Mellitus - Insulin
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Type 2 Diabetes Mellitus - Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Control - Insulin
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Control - Placebo
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 participants at risk
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 participants at risk
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 participants at risk
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 participants at risk
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac disorders - Others, specify
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Infections and infestations
Lung infection
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Nervous system disorders
Stroke
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
Other adverse events
| Measure |
Type 2 Diabetes Mellitus - Insulin
n=51 participants at risk
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Type 2 Diabetes Mellitus - Placebo
n=55 participants at risk
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
Control - Insulin
n=58 participants at risk
40 IU of regular human insulin once daily over 24 weeks
Regular Human Insulin: Regular human insulin 40 IU daily over 24 weeks
|
Control - Placebo
n=59 participants at risk
Intranasal sterile saline once daily over 24 weeks
Placebo: Intranasal sterile saline 40 IU daily over 24 weeks
|
|---|---|---|---|---|
|
General disorders
Flu-like symptoms
|
25.5%
13/51 • Number of events 17 • 48 weeks.
|
20.0%
11/55 • Number of events 12 • 48 weeks.
|
13.8%
8/58 • Number of events 12 • 48 weeks.
|
28.8%
17/59 • Number of events 17 • 48 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
6/51 • Number of events 6 • 48 weeks.
|
5.5%
3/55 • Number of events 4 • 48 weeks.
|
6.9%
4/58 • Number of events 4 • 48 weeks.
|
6.8%
4/59 • Number of events 4 • 48 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
2/51 • Number of events 2 • 48 weeks.
|
12.7%
7/55 • Number of events 8 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Nervous system disorders
Dizziness
|
3.9%
2/51 • Number of events 2 • 48 weeks.
|
7.3%
4/55 • Number of events 4 • 48 weeks.
|
5.2%
3/58 • Number of events 4 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.8%
5/51 • Number of events 5 • 48 weeks.
|
5.5%
3/55 • Number of events 6 • 48 weeks.
|
6.9%
4/58 • Number of events 4 • 48 weeks.
|
6.8%
4/59 • Number of events 4 • 48 weeks.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 3 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
3.4%
2/58 • Number of events 2 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
3.4%
2/59 • Number of events 2 • 48 weeks.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
3.9%
2/51 • Number of events 2 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
3.4%
2/58 • Number of events 2 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Infections and infestations
Tooth infection
|
3.9%
2/51 • Number of events 2 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/51 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
General disorders
Edema limbs
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
3.4%
2/58 • Number of events 2 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
3.4%
2/58 • Number of events 2 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
3.4%
2/59 • Number of events 2 • 48 weeks.
|
|
General disorders
Pain
|
0.00%
0/51 • 48 weeks.
|
5.5%
3/55 • Number of events 3 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
3.4%
2/59 • Number of events 2 • 48 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
5.2%
3/58 • Number of events 3 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
5.1%
3/59 • Number of events 3 • 48 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • Number of events 2 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
3.4%
2/58 • Number of events 2 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/51 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
3/51 • Number of events 3 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Reproductive system and breast disorders
Breast pain
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Infections and infestations
Eye infection
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/51 • 48 weeks.
|
3.6%
2/55 • Number of events 2 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Eye disorders
Cataract
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Nervous system disorders
Confusion
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Eye disorders
Dry eye
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
0.00%
0/51 • 48 weeks.
|
1.8%
1/55 • Number of events 1 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 2 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Eye disorders
Retinal tear
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Infections and infestations
Skin infection
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
1.7%
1/59 • Number of events 1 • 48 weeks.
|
|
Nervous system disorders
Vertigo
|
2.0%
1/51 • Number of events 1 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
0.00%
0/58 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
|
Investigations
Weight loss
|
0.00%
0/51 • 48 weeks.
|
0.00%
0/55 • 48 weeks.
|
1.7%
1/58 • Number of events 1 • 48 weeks.
|
0.00%
0/59 • 48 weeks.
|
Additional Information
Dr. Vera Novak, Principal Investigator
Beth Israel Deaconess Medical Center (BIDMC)
Phone: 6176328680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place