Trial Outcomes & Findings for Intranasal Insulin for Weight Management During Smoking Cessation (NCT NCT02028871)
NCT ID: NCT02028871
Last Updated: 2018-12-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
90 minutes
Results posted on
2018-12-10
Participant Flow
Participant milestones
| Measure |
Intranasal Insulin Arm
Active Treatment First
|
Placebo
Placebo treatment first
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Intranasal Insulin Arm
Active Treatment First
|
Placebo
Placebo treatment first
|
|---|---|---|
|
Overall Study
Positive urine drug screen
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
IV placement difficulty
|
1
|
0
|
|
Overall Study
Current Illness
|
1
|
0
|
Baseline Characteristics
Intranasal Insulin for Weight Management During Smoking Cessation
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo first
|
Intranasal Insulin Arm
n=10 Participants
Active treatment first
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.33 years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
29.30 years
STANDARD_DEVIATION 7.14 • n=7 Participants
|
33.57895 years
STANDARD_DEVIATION 10.81198 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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: 90 minutesOutcome measures
| Measure |
Intranasal Insulin Arm
n=19 Participants
Active Treatment
|
Placebo
n=19 Participants
Placebo treatment
|
|---|---|---|
|
Amount Eaten in Taste Test
|
124 grams
Standard Deviation 48
|
116 grams
Standard Deviation 66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 210 minutesRange: 7-70. Higher scores mean worse outcome
Outcome measures
| Measure |
Intranasal Insulin Arm
n=19 Participants
Active Treatment
|
Placebo
n=19 Participants
Placebo treatment
|
|---|---|---|
|
Nicotine Cravings Measured by Questionnaire of Smoking Urges
|
35.98 score on a scale
Standard Error 1.20
|
32.52 score on a scale
Standard Error 1.05
|
Adverse Events
Intranasal Insulin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Follow up
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Insulin
n=26 participants at risk
Group Receiving Intranasal Insulin
|
Placebo
n=24 participants at risk
Group Receiving Placebo
|
Follow up
n=19 participants at risk
Total Participants Completed Study
|
|---|---|---|---|
|
General disorders
Irritation
|
19.2%
5/26 • Number of events 7 • 240 minutes
|
12.5%
3/24 • Number of events 5 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Headache
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Confusion
|
7.7%
2/26 • Number of events 2 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Tingling (mouth)
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Shaking
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Smell
|
3.8%
1/26 • Number of events 2 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Sneezing
|
3.8%
1/26 • Number of events 2 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Congestion
|
3.8%
1/26 • Number of events 2 • 240 minutes
|
8.3%
2/24 • Number of events 3 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Pain
|
0.00%
0/26 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Fainter Sniffin Sticks
|
7.7%
2/26 • Number of events 2 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Nasal Abrasions
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Sweating
|
7.7%
2/26 • Number of events 2 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Visual Disturbances
|
0.00%
0/26 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Itchiness
|
0.00%
0/26 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Diarrhea
|
0.00%
0/26 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Fatigue
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Body Pain
|
0.00%
0/26 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Menorrhagia
|
0.00%
0/26 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
5.3%
1/19 • Number of events 1 • 240 minutes
|
|
General disorders
Restlessness
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Confined
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Uncomfortable
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
0.00%
0/24 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Eyes Watering
|
3.8%
1/26 • Number of events 2 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
|
General disorders
Hunger
|
3.8%
1/26 • Number of events 1 • 240 minutes
|
4.2%
1/24 • Number of events 1 • 240 minutes
|
0.00%
0/19 • 240 minutes
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place