Trial Outcomes & Findings for Effect of Intranasal Insulin on LH Concentrations in Man (NCT NCT02154477)
NCT ID: NCT02154477
Last Updated: 2019-08-13
Results Overview
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
4 hours
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Control
lean healthy men, randomized to receive saline or insulin at first visit and the alternate treatment at second visit
|
Diabetes
men with diabetes, randomized to receive saline or insulin at first visit and the alternate treatment at second visit
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intranasal Insulin on LH Concentrations in Man
Baseline characteristics by cohort
| Measure |
Diabetes
n=8 Participants
All patients will be randomized to receive either insulin or saline at first visit and alternate treatment at the second visit
intranasal insulin
placebo (intranasal saline)
|
Control
n=6 Participants
All control subjects will be randomized to receive either insulin or saline at first visit and alternate treatment at the second visit
intranasal insulin
placebo (intranasal saline)
|
Total
n=14 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
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 7 • n=5 Participants
|
30 years
STANDARD_DEVIATION 9 • n=7 Participants
|
48 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: diabetes
Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms
Outcome measures
| Measure |
Diabetes
n=8 Participants
All patient will receive insulin at one visit and saline at another visit
intranasal insulin
placebo (intranasal saline)
|
Control
n=6 Participants
lean healthy men. All men will receive insulin at one visit and saline at the other.
|
|---|---|---|
|
LH
baseline
|
7.7 IU/L
Standard Deviation 3
|
3.3 IU/L
Standard Deviation 1.4
|
|
LH
post-intervention saline
|
7.9 IU/L
Standard Deviation 4.3
|
3.8 IU/L
Standard Deviation 1.4
|
|
LH
post-intervention insulin
|
8 IU/L
Standard Deviation 3.4
|
3.4 IU/L
Standard Deviation 1.2
|
Adverse Events
Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place