Trial Outcomes & Findings for Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants (NCT NCT05062785)
NCT ID: NCT05062785
Last Updated: 2026-03-27
Results Overview
Results reflect the participants who experienced severe hypoglycemia generically at the time they received a dose of insulin, as defined by blood glucose \< 45 milligrams per deciliter (mg/dL). Severe hypoglycemia was considered a dose limiting toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Within 4 hours of dosing during each of 5 visits
Results posted on
2026-03-27
Participant Flow
The dosing schedule for each cohort was based on the occurrence of SAEs in the previous cohort. If no SAE occurred in any of the cohort's participants, then the dose escalation schedule for the next cohort was weighted towards higher doses and excluded a lower dose. One participant in Cohort 2 did not attend the final visit after Cohort 3 had already begun, so Cohort 3's dosing was not adjusted. Only Cohort 4 adaptively shifted to higher doses.
Participant milestones
| Measure |
Cohort 1
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 units (U) insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 1 were supposed to receive a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Study Visit 1
STARTED
|
6
|
6
|
6
|
6
|
|
Study Visit 1
Placebo
|
6
|
6
|
6
|
6
|
|
Study Visit 1
100 units
|
4
|
0
|
0
|
0
|
|
Study Visit 1
200 units
|
2
|
6
|
6
|
0
|
|
Study Visit 1
400 units
|
0
|
0
|
0
|
6
|
|
Study Visit 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Study Visit 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 1 (Up to 10 days)
STARTED
|
6
|
6
|
6
|
6
|
|
Washout 1 (Up to 10 days)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Washout 1 (Up to 10 days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Study Visit 2
STARTED
|
6
|
6
|
6
|
5
|
|
Study Visit 2
400 units
|
6
|
6
|
6
|
0
|
|
Study Visit 2
600 units
|
0
|
0
|
0
|
5
|
|
Study Visit 2
COMPLETED
|
6
|
6
|
6
|
5
|
|
Study Visit 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 2 (Up to 10 days)
STARTED
|
6
|
6
|
6
|
5
|
|
Washout 2 (Up to 10 days)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Washout 2 (Up to 10 days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Visit 3
STARTED
|
6
|
6
|
6
|
5
|
|
Study Visit 3
600 units
|
6
|
6
|
6
|
0
|
|
Study Visit 3
800 units
|
0
|
0
|
0
|
5
|
|
Study Visit 3
COMPLETED
|
6
|
6
|
6
|
5
|
|
Study Visit 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 3 (Up to 10 days)
STARTED
|
6
|
6
|
6
|
5
|
|
Washout 3 (Up to 10 days)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Washout 3 (Up to 10 days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Visit 4
STARTED
|
6
|
6
|
6
|
5
|
|
Study Visit 4
500 units
|
1
|
0
|
0
|
0
|
|
Study Visit 4
800 units
|
5
|
6
|
6
|
0
|
|
Study Visit 4
900 units
|
0
|
0
|
0
|
5
|
|
Study Visit 4
COMPLETED
|
6
|
6
|
6
|
5
|
|
Study Visit 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 4 (Up to 10 days)
STARTED
|
6
|
6
|
6
|
5
|
|
Washout 4 (Up to 10 days)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Washout 4 (Up to 10 days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Visit 5
STARTED
|
6
|
6
|
6
|
5
|
|
Study Visit 5
500 units
|
1
|
0
|
0
|
0
|
|
Study Visit 5
1000 units
|
5
|
6
|
6
|
5
|
|
Study Visit 5
COMPLETED
|
6
|
6
|
6
|
5
|
|
Study Visit 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 units (U) insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 1 were supposed to receive a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Washout 1 (Up to 10 days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 1 were supposed to receive a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 13.7 • n=56 Participants
|
41.8 years
STANDARD_DEVIATION 16.2 • n=62 Participants
|
52.8 years
STANDARD_DEVIATION 11.7 • n=123 Participants
|
42.7 years
STANDARD_DEVIATION 11.2 • n=53 Participants
|
49.7 years
STANDARD_DEVIATION 16.0 • n=654 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
3 Participants
n=53 Participants
|
12 Participants
n=654 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
3 Participants
n=53 Participants
|
12 Participants
n=654 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
23 Participants
n=654 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=53 Participants
|
4 Participants
n=654 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
4 Participants
n=53 Participants
|
18 Participants
n=654 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
6 Participants
n=53 Participants
|
24 Participants
n=654 Participants
|
PRIMARY outcome
Timeframe: Within 4 hours of dosing during each of 5 visitsResults reflect the participants who experienced severe hypoglycemia generically at the time they received a dose of insulin, as defined by blood glucose \< 45 milligrams per deciliter (mg/dL). Severe hypoglycemia was considered a dose limiting toxicity (DLT).
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Severe Hypoglycemia
Study Visit 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severe Hypoglycemia
Study Visit 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severe Hypoglycemia
Study Visit 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severe Hypoglycemia
Study Visit 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severe Hypoglycemia
Study Visit 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 4 hours after drug administration (Study Visit 1, Day 1)Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=4 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
240 Minutes Post Insulin Administration
|
96.3 mg per dL
Standard Deviation 15.1
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
Baseline
|
94.8 mg per dL
Standard Deviation 6.7
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
15 Minutes Post Insulin Administration
|
92.5 mg per dL
Standard Deviation 6.2
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
30 Minutes Post Insulin Administration
|
91.8 mg per dL
Standard Deviation 13.8
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
60 Minutes Post Insulin Administration
|
90.0 mg per dL
Standard Deviation 10.8
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
120 Minutes Post Insulin Administration
|
88.0 mg per dL
Standard Deviation 7.3
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (100 Units)
180 Minutes Post Insulin Administration
|
91.5 mg per dL
Standard Deviation 11.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=2 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
Baseline
|
79 mg per dL
Standard Deviation 7.1
|
94.2 mg per dL
Standard Deviation 8.2
|
90.2 mg per dL
Standard Deviation 7.5
|
—
|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
120 Minutes Post Insulin Administration
|
77 mg per dL
Standard Deviation 9.9
|
93.2 mg per dL
Standard Deviation 9.8
|
88.3 mg per dL
Standard Deviation 9.8
|
—
|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
180 Minutes Post Insulin Administration
|
79 mg per dL
Standard Deviation 9.9
|
92.5 mg per dL
Standard Deviation 11.0
|
88.0 mg per dL
Standard Deviation 13.9
|
—
|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
240 Minutes Post Insulin Administration
|
76 mg per dL
Standard Deviation 4.2
|
89.9 mg per dL
Standard Deviation 7.3
|
87.3 mg per dL
Standard Deviation 9.0
|
—
|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
15 Minutes Post Insulin Administration
|
77.5 mg per dL
Standard Deviation 7.8
|
90.8 mg per dL
Standard Deviation 10.4
|
93.8 mg per dL
Standard Deviation 10.8
|
—
|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
30 Minutes Post Insulin Administration
|
75.5 mg per dL
Standard Deviation 9.2
|
92.3 mg per dL
Standard Deviation 8.0
|
86.3 mg per dL
Standard Deviation 11.3
|
—
|
|
Change in Blood Glucose - Study Visit 1 (200 Units)
60 Minutes Post Insulin Administration
|
77 mg per dL
Standard Deviation 7.1
|
91.5 mg per dL
Standard Deviation 9.9
|
89.2 mg per dL
Standard Deviation 10.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
Baseline
|
95.8 mg per dL
Standard Deviation 11.5
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
30 Minutes Post Insulin Administration
|
93.8 mg per dL
Standard Deviation 7.5
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
60 Minutes Post Insulin Administration
|
96.3 mg per dL
Standard Deviation 8.9
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
120 Minutes Post Insulin Administration
|
92.3 mg per dL
Standard Deviation 2.7
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
180 Minutes Post Insulin Administration
|
91.2 mg per dL
Standard Deviation 8.6
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
15 Minutes Post Insulin Administration
|
97.0 mg per dL
Standard Deviation 8.1
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 1 (400 Units)
240 Minutes Post Insulin Administration
|
88.8 mg per dL
Standard Deviation 10.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
Baseline
|
83.8 mg per dL
Standard Deviation 9.5
|
88.3 mg per dL
Standard Deviation 16.3
|
93.3 mg per dL
Standard Deviation 6.7
|
—
|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
15 Minutes Post Insulin Administration
|
84.8 mg per dL
Standard Deviation 3.6
|
91.7 mg per dL
Standard Deviation 5.4
|
88.7 mg per dL
Standard Deviation 6.3
|
—
|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
30 Minutes Post Insulin Administration
|
83.8 mg per dL
Standard Deviation 2.4
|
89.8 mg per dL
Standard Deviation 11.0
|
86.3 mg per dL
Standard Deviation 9.4
|
—
|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
60 Minutes Post Insulin Administration
|
80.4 mg per dL
Standard Deviation 6.1
|
90.3 mg per dL
Standard Deviation 5.3
|
85.0 mg per dL
Standard Deviation 4.2
|
—
|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
120 Minutes Post Insulin Administration
|
81.7 mg per dL
Standard Deviation 5.7
|
90.5 mg per dL
Standard Deviation 5.5
|
85.5 mg per dL
Standard Deviation 8.3
|
—
|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
180 Minutes Post Insulin Administration
|
80 mg per dL
Standard Deviation 3.3
|
90.8 mg per dL
Standard Deviation 4.8
|
83.8 mg per dL
Standard Deviation 9.1
|
—
|
|
Change in Blood Glucose - Study Visit 2 (400 Units)
240 Minutes Post Insulin Administration
|
82.5 mg per dL
Standard Deviation 4.0
|
92.2 mg per dL
Standard Deviation 6.1
|
84.5 mg per dL
Standard Deviation 7.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
Baseline
|
93.6 mg per dL
Standard Deviation 6.6
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
15 Minutes Post Insulin Administration
|
93.8 mg per dL
Standard Deviation 11.7
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
30 Minutes Post Insulin Administration
|
85.0 mg per dL
Standard Deviation 19.4
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
60 Minutes Post Insulin Administration
|
97.0 mg per dL
Standard Deviation 6.9
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
120 Minutes Post Insulin Administration
|
94.8 mg per dL
Standard Deviation 4.6
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
180 Minutes Post Insulin Administration
|
93.8 mg per dL
Standard Deviation 5.6
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 2 (600 Units)
240 Minutes Post Insulin Administration
|
95.6 mg per dL
Standard Deviation 3.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant experienced a hypoglycemic episode, and blood was drawn at additional intervals. The additional intervals were neither prespecified outcome measures nor intended to be outcome measures and were collected for safety data only.
Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
60 Minutes Post Insulin Administration
|
100.2 mg per dL
Standard Deviation 56.4
|
89.0 mg per dL
Standard Deviation 10.4
|
86.7 mg per dL
Standard Deviation 12.7
|
—
|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
120 Minutes Post Insulin Administration
|
79.3 mg per dL
Standard Deviation 8.1
|
90.8 mg per dL
Standard Deviation 6.8
|
91.8 mg per dL
Standard Deviation 15.0
|
—
|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
Baseline
|
82.5 mg per dL
Standard Deviation 6.1
|
94.5 mg per dL
Standard Deviation 16.0
|
94.2 mg per dL
Standard Deviation 5.1
|
—
|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
15 Minutes Post Insulin Administration
|
86.2 mg per dL
Standard Deviation 7.0
|
88.0 mg per dL
Standard Deviation 10.2
|
96.8 mg per dL
Standard Deviation 11.2
|
—
|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
30 Minutes Post Insulin Administration
|
75.3 mg per dL
Standard Deviation 13.6
|
88.3 mg per dL
Standard Deviation 13.2
|
90.3 mg per dL
Standard Deviation 8.5
|
—
|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
180 Minutes Post Insulin Administration
|
80.7 mg per dL
Standard Deviation 5.2
|
85.8 mg per dL
Standard Deviation 7.7
|
92.3 mg per dL
Standard Deviation 13.2
|
—
|
|
Change in Blood Glucose - Study Visit 3 (600 Units)
240 Minutes Post Insulin Administration
|
80.0 mg per dL
Standard Deviation 6.9
|
85.7 mg per dL
Standard Deviation 11.3
|
94.3 mg per dL
Standard Deviation 10.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
Baseline
|
97.8 mg per dL
Standard Deviation 14.9
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
15 Minutes Post Insulin Administration
|
97.6 mg per dL
Standard Deviation 13.5
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
30 Minutes Post Insulin Administration
|
97.2 mg per dL
Standard Deviation 13.5
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
60 Minutes Post Insulin Administration
|
97.0 mg per dL
Standard Deviation 10.2
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
120 Minutes Post Insulin Administration
|
101.6 mg per dL
Standard Deviation 11.4
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
180 Minutes Post Insulin Administration
|
95.8 mg per dL
Standard Deviation 8.6
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 3 (800 Units)
240 Minutes Post Insulin Administration
|
94.2 mg per dL
Standard Deviation 6.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
30 Minutes Post Insulin Administration
|
85.0 mg per dL
Standard Deviation 9.1
|
87.5 mg per dL
Standard Deviation 5.4
|
78.5 mg per dL
Standard Deviation 9.8
|
—
|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
60 Minutes Post Insulin Administration
|
83.2 mg per dL
Standard Deviation 11.2
|
86.0 mg per dL
Standard Deviation 8.5
|
83 mg per dL
Standard Deviation 13.7
|
—
|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
120 Minutes Post Insulin Administration
|
87.0 mg per dL
Standard Deviation 5.8
|
87.0 mg per dL
Standard Deviation 9.3
|
86.0 mg per dL
Standard Deviation 10.3
|
—
|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
180 Minutes Post Insulin Administration
|
87.6 mg per dL
Standard Deviation 2.9
|
91.2 mg per dL
Standard Deviation 7.4
|
90.2 mg per dL
Standard Deviation 10.3
|
—
|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
Baseline
|
87.8 mg per dL
Standard Deviation 7.7
|
98.8 mg per dL
Standard Deviation 9.8
|
91.2 mg per dL
Standard Deviation 10.6
|
—
|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
15 Minutes Post Insulin Administration
|
82.2 mg per dL
Standard Deviation 7.4
|
90.5 mg per dL
Standard Deviation 6.0
|
87.7 mg per dL
Standard Deviation 13.5
|
—
|
|
Change in Blood Glucose - Study Visit 4 (800 Units)
240 Minutes Post Insulin Administration
|
90.4 mg per dL
Standard Deviation 11.9
|
90.8 mg per dL
Standard Deviation 7.7
|
85.2 mg per dL
Standard Deviation 7.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
15 Minutes Post Insulin Administration
|
101.2 mg per dL
Standard Deviation 12.1
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
30 Minutes Post Insulin Administration
|
93.8 mg per dL
Standard Deviation 14.4
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
Baseline
|
100.8 mg per dL
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
60 Minutes Post Insulin Administration
|
93.2 mg per dL
Standard Deviation 15.6
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
120 Minutes Post Insulin Administration
|
97.6 mg per dL
Standard Deviation 18.7
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
180 Minutes Post Insulin Administration
|
98.6 mg per dL
Standard Deviation 12.0
|
—
|
—
|
—
|
|
Change in Blood Glucose - Study Visit 4 (900 Units)
240 Minutes Post Insulin Administration
|
100.4 mg per dL
Standard Deviation 5.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant in Cohort 4 withdrew from the trial prior to Study Visit 2.
Change in participant blood glucose from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. Higher numbers indicated a higher level of blood glucose. This procedure was followed at each study visit.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
Baseline
|
86.6 mg per dL
Standard Deviation 3.5
|
90.8 mg per dL
Standard Deviation 3.5
|
96.2 mg per dL
Standard Deviation 8.7
|
100.4 mg per dL
Standard Deviation 15.9
|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
15 Minutes Post Insulin Administration
|
82.6 mg per dL
Standard Deviation 0.9
|
90.8 mg per dL
Standard Deviation 5.1
|
90.7 mg per dL
Standard Deviation 4.2
|
103.0 mg per dL
Standard Deviation 18.5
|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
30 Minutes Post Insulin Administration
|
77.8 mg per dL
Standard Deviation 3.3
|
85.0 mg per dL
Standard Deviation 4.0
|
85.0 mg per dL
Standard Deviation 7.3
|
98.2 mg per dL
Standard Deviation 22.4
|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
60 Minutes Post Insulin Administration
|
83.6 mg per dL
Standard Deviation 4.2
|
89.3 mg per dL
Standard Deviation 10.3
|
82.7 mg per dL
Standard Deviation 5.5
|
97.6 mg per dL
Standard Deviation 21.7
|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
240 Minutes Post Insulin Administration
|
86.0 mg per dL
Standard Deviation 12.3
|
87.8 mg per dL
Standard Deviation 7.2
|
90.7 mg per dL
Standard Deviation 7.3
|
98.2 mg per dL
Standard Deviation 17.4
|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
120 Minutes Post Insulin Administration
|
83.2 mg per dL
Standard Deviation 7.0
|
87.7 mg per dL
Standard Deviation 9.6
|
87.7 mg per dL
Standard Deviation 5.1
|
96.2 mg per dL
Standard Deviation 16.1
|
|
Change in Blood Glucose - Study Visit 5 (1000 Units)
180 Minutes Post Insulin Administration
|
86.0 mg per dL
Standard Deviation 9.5
|
88.5 mg per dL
Standard Deviation 7.6
|
88.8 mg per dL
Standard Deviation 9.3
|
98.2 mg per dL
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study visit. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=4 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
Baseline
|
0.8 ng per mL
Standard Deviation 0.1
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
240 Minutes Post Insulin Administration
|
0.6 ng per mL
Standard Deviation 0.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
15 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.4
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
30 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
60 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.4
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
120 Minutes Post Insulin Administration
|
0.7 ng per mL
Standard Deviation 0.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (100 Units)
180 Minutes Post Insulin Administration
|
0.7 ng per mL
Standard Deviation 0.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study visit. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=2 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
Baseline
|
1.0 ng per mL
Standard Deviation 0.0
|
2.5 ng per mL
Standard Deviation 1.0
|
1.2 ng per mL
Standard Deviation 0.3
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
15 Minutes Post Insulin Administration
|
1.0 ng per mL
Standard Deviation 0.1
|
2.2 ng per mL
Standard Deviation 0.9
|
1.2 ng per mL
Standard Deviation 0.3
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
30 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.1
|
2.0 ng per mL
Standard Deviation 0.8
|
1.0 ng per mL
Standard Deviation 0.3
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
60 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 01
|
2.0 ng per mL
Standard Deviation 0.8
|
1.0 ng per mL
Standard Deviation 0.3
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
120 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.1
|
2.1 ng per mL
Standard Deviation 0.8
|
1.1 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
180 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.1
|
1.3 ng per mL
Standard Deviation 0.6
|
1.0 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (200 Units)
240 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.1
|
2.0 ng per mL
Standard Deviation 0.9
|
1.0 ng per mL
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study visit. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
240 Minutes Post Insulin Administration
|
1.4 ng per mL
Standard Deviation 0.9
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
Baseline
|
2.2 ng per mL
Standard Deviation 1.5
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
15 Minutes Post Insulin Administration
|
1.9 ng per mL
Standard Deviation 1.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
30 Minutes Post Insulin Administration
|
1.9 ng per mL
Standard Deviation 1.1
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
60 Minutes Post Insulin Administration
|
1.7 ng per mL
Standard Deviation 1.1
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
120 Minutes Post Insulin Administration
|
1.6 ng per mL
Standard Deviation 1.0
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 1 (400 Units)
180 Minutes Post Insulin Administration
|
1.4 ng per mL
Standard Deviation 0.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
30 Minutes Post Insulin Administration
|
1.2 ng per mL
Standard Deviation 0.44
|
2.0 ng per mL
Standard Deviation 0.9
|
1.6 ng per mL
Standard Deviation 0.5
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
60 Minutes Post Insulin Administration
|
1.1 ng per mL
Standard Deviation 0.4
|
2.0 ng per mL
Standard Deviation 1.0
|
1.2 ng per mL
Standard Deviation 0.5
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
Baseline
|
1.4 ng per mL
Standard Deviation 0.4
|
2.4 ng per mL
Standard Deviation 0.9
|
2.1 ng per mL
Standard Deviation 0.7
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
15 Minutes Post Insulin Administration
|
1.3 ng per mL
Standard Deviation 0.4
|
2.0 ng per mL
Standard Deviation 0.9
|
1.7 ng per mL
Standard Deviation 0.6
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
120 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.2
|
1.9 ng per mL
Standard Deviation 0.8
|
1.0 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
180 Minutes Post Insulin Administration
|
1.0 ng per mL
Standard Deviation 0.3
|
1.8 ng per mL
Standard Deviation 0.8
|
1.0 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (400 Units)
240 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.3
|
1.6 ng per mL
Standard Deviation 0.7
|
1.0 ng per mL
Standard Deviation 0.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
Baseline
|
2.6 ng per mL
Standard Deviation 1.8
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
15 Minutes Post Insulin Administration
|
2.2 ng per mL
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
30 Minutes Post Insulin Administration
|
2.0 ng per mL
Standard Deviation 1.6
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
60 Minutes Post Insulin Administration
|
1.7 ng per mL
Standard Deviation 0.5
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
120 Minutes Post Insulin Administration
|
2.5 ng per mL
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
180 Minutes Post Insulin Administration
|
1.9 ng per mL
Standard Deviation 1.2
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 2 (600 Units)
240 Minutes Post Insulin Administration
|
1.8 ng per mL
Standard Deviation 1.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
30 Minutes Post Insulin Administration
|
1.13 ng per mL
Standard Deviation 0.3
|
2.32 ng per mL
Standard Deviation 1.7
|
2.1 ng per mL
Standard Deviation 1.5
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
Baseline
|
1.33 ng per mL
Standard Deviation 0.6
|
2.8 ng per mL
Standard Deviation 1.9
|
2.9 ng per mL
Standard Deviation 2.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
15 Minutes Post Insulin Administration
|
1.24 ng per mL
Standard Deviation 0.4
|
2.4 ng per mL
Standard Deviation 1.6
|
2.4 ng per mL
Standard Deviation 1.8
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
60 Minutes Post Insulin Administration
|
4.3 ng per mL
Standard Deviation 0.8
|
2.2 ng per mL
Standard Deviation 1.5
|
1.5 ng per mL
Standard Deviation 0.8
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
120 Minutes Post Insulin Administration
|
1.03 ng per mL
Standard Deviation 0.4
|
2.8 ng per mL
Standard Deviation 1.9
|
1.2 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
180 Minutes Post Insulin Administration
|
13.2 ng per mL
Standard Deviation 0.9
|
1.7 ng per mL
Standard Deviation 0.8
|
1.2 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (600 Units)
240 Minutes Post Insulin Administration
|
0.87 ng per mL
Standard Deviation 0.6
|
1.7 ng per mL
Standard Deviation 0.8
|
1.2 ng per mL
Standard Deviation 0.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
Baseline
|
5.2 ng per mL
Standard Deviation 6.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
15 Minutes Post Insulin Administration
|
3.2 ng per mL
Standard Deviation 2.8
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
30 Minutes Post Insulin Administration
|
2.8 ng per mL
Standard Deviation 2.1
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
60 Minutes Post Insulin Administration
|
2.4 ng per mL
Standard Deviation 1.8
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
120 Minutes Post Insulin Administration
|
2.2 ng per mL
Standard Deviation 1.2
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
180 Minutes Post Insulin Administration
|
2.0 ng per mL
Standard Deviation 1.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 3 (800 Units)
240 Minutes Post Insulin Administration
|
2.0 ng per mL
Standard Deviation 1.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationChange in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
120 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.3
|
2.2 ng per mL
Standard Deviation 0.8
|
1.1 ng per mL
Standard Deviation 0.7
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
Baseline
|
1.2 ng per mL
Standard Deviation 0.5
|
3.2 ng per mL
Standard Deviation 1.2
|
2.4 ng per mL
Standard Deviation 1.0
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
15 Minutes Post Insulin Administration
|
1.1 ng per mL
Standard Deviation 0.3
|
2.4 ng per mL
Standard Deviation 0.9
|
1.9 ng per mL
Standard Deviation 0.9
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
30 Minutes Post Insulin Administration
|
1.0 ng per mL
Standard Deviation 0.2
|
2.5 ng per mL
Standard Deviation 0.8
|
1.6 ng per mL
Standard Deviation 0.7
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
60 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.2
|
2.3 ng per mL
Standard Deviation 0.9
|
1.2 ng per mL
Standard Deviation 0.6
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
180 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.3
|
2.1 ng per mL
Standard Deviation 0.6
|
1.0 ng per mL
Standard Deviation 0.4
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (800 Units)
240 Minutes Post Insulin Administration
|
1.1 ng per mL
Standard Deviation 0.7
|
2.0 ng per mL
Standard Deviation 0.7
|
1.0 ng per mL
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
180 Minutes Post Insulin Administration
|
1.8 ng per mL
Standard Deviation 1.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
240 Minutes Post Insulin Administration
|
1.9 ng per mL
Standard Deviation 1.1
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
Baseline
|
2.9 ng per mL
Standard Deviation 1.5
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
15 Minutes Post Insulin Administration
|
2.4 ng per mL
Standard Deviation 1.2
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
30 Minutes Post Insulin Administration
|
2.2 ng per mL
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
60 Minutes Post Insulin Administration
|
1.9 ng per mL
Standard Deviation 1.3
|
—
|
—
|
—
|
|
Change in Serum C-peptide Levels - Study Visit 4 (900 Units)
120 Minutes Post Insulin Administration
|
1.9 ng per mL
Standard Deviation 1.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant in Cohort 4 withdrew from the trial prior to Study Visit 2.
Change in participant C-peptide Levels from baseline as measured by blood draws taken at 15-minute and 30-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study. C-peptide levels in the blood indicate how much insulin the pancreas is producing. Lower C-peptide levels suggest the body is producing little or no insulin, while higher C-peptide levels may indicate insulin resistance.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
Baseline
|
1.8 ng per mL
Standard Deviation 1.4
|
2.8 ng per mL
Standard Deviation 1.1
|
2.7 ng per mL
Standard Deviation 1.8
|
3.1 ng per mL
Standard Deviation 2.5
|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
15 Minutes Post Insulin Administration
|
1.3 ng per mL
Standard Deviation 0.6
|
2.4 ng per mL
Standard Deviation 1.0
|
2.0 ng per mL
Standard Deviation 1.0
|
2.9 ng per mL
Standard Deviation 2.1
|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
60 Minutes Post Insulin Administration
|
0.9 ng per mL
Standard Deviation 0.4
|
2.2 ng per mL
Standard Deviation 0.9
|
1.3 ng per mL
Standard Deviation 0.6
|
2.6 ng per mL
Standard Deviation 2.6
|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
240 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.3
|
1.9 ng per mL
Standard Deviation 0.7
|
1.0 ng per mL
Standard Deviation 0.4
|
2.0 ng per mL
Standard Deviation 1.8
|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
30 Minutes Post Insulin Administration
|
1.1 ng per mL
Standard Deviation 0.5
|
2.2 ng per mL
Standard Deviation 0.9
|
1.7 ng per mL
Standard Deviation 0.9
|
2.8 ng per mL
Standard Deviation 2.1
|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
120 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.2
|
2.1 ng per mL
Standard Deviation 0.8
|
1.1 ng per mL
Standard Deviation 0.5
|
2.4 ng per mL
Standard Deviation 2.4
|
|
Change in Serum C-peptide Levels - Study Visit 5 (1000 Units)
180 Minutes Post Insulin Administration
|
0.8 ng per mL
Standard Deviation 0.3
|
2.0 ng per mL
Standard Deviation 0.8
|
1.1 ng per mL
Standard Deviation 0.4
|
2.4 ng per mL
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationSerum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=4 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
Baseline
|
4.9 µU/mL
Standard Deviation 1.2
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
15 Minutes Post Insulin Administration
|
6.2 µU/mL
Standard Deviation 2.4
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
30 Minutes Post Insulin Administration
|
5.8 µU/mL
Standard Deviation 1.9
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
60 Minutes Post Insulin Administration
|
5.2 µU/mL
Standard Deviation 2.8
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
120 Minutes Post Insulin Administration
|
5.6 µU/mL
Standard Deviation 1.7
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
180 Minutes Post Insulin Administration
|
4.7 µU/mL
Standard Deviation 1.8
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (100 Units)
240 Minutes Post Insulin Administration
|
5.3 µU/mL
Standard Deviation 1.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationSerum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=2 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
Baseline
|
7.1 µU/mL
Standard Deviation 0.6
|
19.5 µU/mL
Standard Deviation 7.6
|
7.8 µU/mL
Standard Deviation 1.3
|
—
|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
15 Minutes Post Insulin Administration
|
9.5 µU/mL
Standard Deviation 4.7
|
18.0 µU/mL
Standard Deviation 5.4
|
11.7 µU/mL
Standard Deviation 4.7
|
—
|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
30 Minutes Post Insulin Administration
|
7.9 µU/mL
Standard Deviation 2.1
|
15.6 µU/mL
Standard Deviation 4.6
|
11.1 µU/mL
Standard Deviation 3.8
|
—
|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
60 Minutes Post Insulin Administration
|
6.3 µU/mL
Standard Deviation 1.5
|
15.4 µU/mL
Standard Deviation 5.5
|
10.0 µU/mL
Standard Deviation 1.9
|
—
|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
120 Minutes Post Insulin Administration
|
5.4 µU/mL
Standard Deviation 0.4
|
16.9 µU/mL
Standard Deviation 5.9
|
8.5 µU/mL
Standard Deviation 1.3
|
—
|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
180 Minutes Post Insulin Administration
|
5.9 µU/mL
Standard Deviation 0.5
|
11.4 µU/mL
Standard Deviation 6.7
|
8.1 µU/mL
Standard Deviation 1.2
|
—
|
|
Change in Serum Insulin - Study Visit 1 (200 Units)
240 Minutes Post Insulin Administration
|
5.3 µU/mL
Standard Deviation 2.1
|
15.4 µU/mL
Standard Deviation 6.4
|
7.8 µU/mL
Standard Deviation 1.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationSerum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
Baseline
|
15.5 µU/mL
Standard Deviation 12.6
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
15 Minutes Post Insulin Administration
|
14.3 µU/mL
Standard Deviation 11.3
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
30 Minutes Post Insulin Administration
|
15.5 µU/mL
Standard Deviation 8.9
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
60 Minutes Post Insulin Administration
|
14.4 µU/mL
Standard Deviation 11.6
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
120 Minutes Post Insulin Administration
|
12.3 µU/mL
Standard Deviation 6.5
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
180 Minutes Post Insulin Administration
|
9.7 µU/mL
Standard Deviation 6.0
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 1 (400 Units)
240 Minutes Post Insulin Administration
|
11.0 µU/mL
Standard Deviation 6.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationSerum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
180 Minutes Post Insulin Administration
|
6.6 µU/mL
Standard Deviation 2.3
|
13.1 µU/mL
Standard Deviation 6.5
|
9.7 µU/mL
Standard Deviation 2.9
|
—
|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
Baseline
|
8.2 µU/mL
Standard Deviation 3.04
|
16.6 µU/mL
Standard Deviation 5.8
|
12.2 µU/mL
Standard Deviation 6.7
|
—
|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
15 Minutes Post Insulin Administration
|
10.8 µU/mL
Standard Deviation 8.5
|
16.5 µU/mL
Standard Deviation 6.3
|
13.9 µU/mL
Standard Deviation 5.7
|
—
|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
30 Minutes Post Insulin Administration
|
10.4 µU/mL
Standard Deviation 7.9
|
16.8 µU/mL
Standard Deviation 6.4
|
13.1 µU/mL
Standard Deviation 3.7
|
—
|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
60 Minutes Post Insulin Administration
|
7.8 µU/mL
Standard Deviation 3.3
|
15.3 µU/mL
Standard Deviation 6.7
|
10.7 µU/mL
Standard Deviation 2.7
|
—
|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
120 Minutes Post Insulin Administration
|
7.0 µU/mL
Standard Deviation 0.8
|
15.1 µU/mL
Standard Deviation 5.2
|
9.7 µU/mL
Standard Deviation 2.9
|
—
|
|
Change in Serum Insulin - Study Visit 2 (400 Units)
240 Minutes Post Insulin Administration
|
6.0 µU/mL
Standard Deviation 2.2
|
12.3 µU/mL
Standard Deviation 4.4
|
8.4 µU/mL
Standard Deviation 1.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
Baseline
|
16.8 µU/mL
Standard Deviation 13.0
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
15 Minutes Post Insulin Administration
|
24.6 µU/mL
Standard Deviation 15.2
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
30 Minutes Post Insulin Administration
|
19.7 µU/mL
Standard Deviation 13.5
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
60 Minutes Post Insulin Administration
|
20.7 µU/mL
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
120 Minutes Post Insulin Administration
|
17.4 µU/mL
Standard Deviation 10.2
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
180 Minutes Post Insulin Administration
|
13.5 µU/mL
Standard Deviation 9.0
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 2 (600 Units)
240 Minutes Post Insulin Administration
|
12.0 µU/mL
Standard Deviation 7.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant experienced a hypoglycemic episode, and blood was drawn at additional intervals. The additional intervals were neither prespecified outcome measures nor intended to be outcome measures and were collected for safety data only.
Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
Baseline
|
6.8 µU/mL
Standard Deviation 1.8
|
19.8 µU/mL
Standard Deviation 13.5
|
14.3 µU/mL
Standard Deviation 15.8
|
—
|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
30 Minutes Post Insulin Administration
|
40.9 µU/mL
Standard Deviation 68.9
|
17.1 µU/mL
Standard Deviation 10.2
|
14.0 µU/mL
Standard Deviation 6.3
|
—
|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
60 Minutes Post Insulin Administration
|
32.4 µU/mL
Standard Deviation 54.4
|
17.7 µU/mL
Standard Deviation 8.9
|
10.8 µU/mL
Standard Deviation 2.6
|
—
|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
15 Minutes Post Insulin Administration
|
30.7 µU/mL
Standard Deviation 53.5
|
18.2 µU/mL
Standard Deviation 11.2
|
14.7 µU/mL
Standard Deviation 7.9
|
—
|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
120 Minutes Post Insulin Administration
|
17.7 µU/mL
Standard Deviation 22.9
|
15.6 µU/mL
Standard Deviation 8.0
|
9.0 µU/mL
Standard Deviation 1.6
|
—
|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
180 Minutes Post Insulin Administration
|
13.2 µU/mL
Standard Deviation 11.3
|
13.9 µU/mL
Standard Deviation 4.8
|
8.1 µU/mL
Standard Deviation 1.7
|
—
|
|
Change in Serum Insulin - Study Visit 3 (600 Units)
240 Minutes Post Insulin Administration
|
8.1 µU/mL
Standard Deviation 8.1
|
13.2 µU/mL
Standard Deviation 4.9
|
7.5 µU/mL
Standard Deviation 1.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2. 1 participant experienced a hypoglycemic episode, and blood was drawn at additional intervals. The additional intervals were neither prespecified outcome measures nor intended to be outcome measures and were collected for safety data only.
Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
Baseline
|
31.0 µU/mL
Standard Deviation 39.5
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
15 Minutes Post Insulin Administration
|
25.3 µU/mL
Standard Deviation 15.9
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
30 Minutes Post Insulin Administration
|
23.0 µU/mL
Standard Deviation 14.8
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
60 Minutes Post Insulin Administration
|
18.6 µU/mL
Standard Deviation 11.8
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
120 Minutes Post Insulin Administration
|
16.2 µU/mL
Standard Deviation 8.8
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
180 Minutes Post Insulin Administration
|
15.0 µU/mL
Standard Deviation 8.3
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 3 (800 Units)
240 Minutes Post Insulin Administration
|
13.7 µU/mL
Standard Deviation 7.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationSerum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
120 Minutes Post Insulin Administration
|
6.8 µU/mL
Standard Deviation 2.3
|
16.9 µU/mL
Standard Deviation 8.0
|
10.0 µU/mL
Standard Deviation 6.0
|
—
|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
Baseline
|
6.7 µU/mL
Standard Deviation 3.3
|
21.5 µU/mL
Standard Deviation 11.2
|
10.2 µU/mL
Standard Deviation 2.9
|
—
|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
15 Minutes Post Insulin Administration
|
7.8 µU/mL
Standard Deviation 4.4
|
20.8 µU/mL
Standard Deviation 7.7
|
16.5 µU/mL
Standard Deviation 6.8
|
—
|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
30 Minutes Post Insulin Administration
|
8.8 µU/mL
Standard Deviation 5.0
|
20.3 µU/mL
Standard Deviation 5.4
|
13.6 µU/mL
Standard Deviation 5.1
|
—
|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
60 Minutes Post Insulin Administration
|
7.3 µU/mL
Standard Deviation 3.4
|
18.6 µU/mL
Standard Deviation 6.1
|
10.9 µU/mL
Standard Deviation 3.7
|
—
|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
180 Minutes Post Insulin Administration
|
6.2 µU/mL
Standard Deviation 1.7
|
16.5 µU/mL
Standard Deviation 5.4
|
7.4 µU/mL
Standard Deviation 1.7
|
—
|
|
Change in Serum Insulin - Study Visit 4 (800 Units)
240 Minutes Post Insulin Administration
|
8.5 µU/mL
Standard Deviation 7.8
|
16.4 µU/mL
Standard Deviation 5.9
|
8.1 µU/mL
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant withdrew from the trial prior to Study Visit 2.
Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
60 Minutes Post Insulin Administration
|
22.0 µU/mL
Standard Deviation 21.7
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
180 Minutes Post Insulin Administration
|
17.9 µU/mL
Standard Deviation 15.9
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
240 Minutes Post Insulin Administration
|
13.7 µU/mL
Standard Deviation 10.1
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
Baseline
|
22.9 µU/mL
Standard Deviation 17.9
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
15 Minutes Post Insulin Administration
|
27.1 µU/mL
Standard Deviation 16.1
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
30 Minutes Post Insulin Administration
|
24.7 µU/mL
Standard Deviation 17.0
|
—
|
—
|
—
|
|
Change in Serum Insulin - Study Visit 4 (900 Units)
120 Minutes Post Insulin Administration
|
18.8 µU/mL
Standard Deviation 17.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours after drug administrationPopulation: 1 participant in Cohort 4 withdrew from the trial prior to Study Visit 2.
Serum insulin refers to the measurement of insulin levels in the blood. Change in participant serum insulin from baseline as measured by blood draws taken at 15-minute, 30-minute, and 60-minute intervals following administration of intra-nasal insulin. This procedure was followed at each study.
Outcome measures
| Measure |
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 2
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 2 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 3
n=6 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 3 received a Placebo and 200 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
Cohort 4
n=5 Participants
Drug: Intranasal insulin This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a 4-hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.
Participants in Cohort 4 received a Placebo and 400 units of insulin at their first study visit.
Other Names:
HUMULIN R U-500
|
|---|---|---|---|---|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
60 Minutes Post Insulin Administration
|
6.6 µU/mL
Standard Deviation 3.3
|
18.9 µU/mL
Standard Deviation 5.9
|
11.0 µU/mL
Standard Deviation 1.0
|
23.1 µU/mL
Standard Deviation 21.2
|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
240 Minutes Post Insulin Administration
|
6.6 µU/mL
Standard Deviation 1.5
|
15.6 µU/mL
Standard Deviation 4.8
|
6.8 µU/mL
Standard Deviation 0.7
|
14.7 µU/mL
Standard Deviation 9.6
|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
Baseline
|
7.1 µU/mL
Standard Deviation 3.1
|
18.9 µU/mL
Standard Deviation 7.7
|
14.8 µU/mL
Standard Deviation 9.5
|
19.5 µU/mL
Standard Deviation 17.5
|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
15 Minutes Post Insulin Administration
|
7.8 µU/mL
Standard Deviation 4.3
|
20.0 µU/mL
Standard Deviation 6.3
|
15.6 µU/mL
Standard Deviation 4.7
|
26.6 µU/mL
Standard Deviation 16.3
|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
30 Minutes Post Insulin Administration
|
8.2 µU/mL
Standard Deviation 4.9
|
19.2 µU/mL
Standard Deviation 5.9
|
14.4 µU/mL
Standard Deviation 3.4
|
24.8 µU/mL
Standard Deviation 17.0
|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
120 Minutes Post Insulin Administration
|
5.8 µU/mL
Standard Deviation 1.5
|
16.4 µU/mL
Standard Deviation 5.0
|
8.9 µU/mL
Standard Deviation 1.7
|
19.7 µU/mL
Standard Deviation 17.1
|
|
Change in Serum Insulin - Study Visit 5 (1000 Units)
180 Minutes Post Insulin Administration
|
5.5 µU/mL
Standard Deviation 1.8
|
14.4 µU/mL
Standard Deviation 4.4
|
7.1 µU/mL
Standard Deviation 2.5
|
18.2 µU/mL
Standard Deviation 15.7
|
Adverse Events
100 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
400 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
500 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600 Units
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
800 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
900 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1000 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 Units
n=4 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
100 Units given intranasally.
|
200 Units
n=14 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
200 Units given intranasally.
|
400 Units
n=24 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
400 Units given intranasally.
|
500 Units
n=1 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
500 Units given intranasally.
|
600 Units
n=23 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
600 Units given intranasally.
|
800 Units
n=22 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
800 Units given intranasally.
|
900 Units
n=5 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
900 Units given intranasally.
|
1000 Units
n=22 participants at risk
Drug: Intranasal insulin (Other Names:
HUMULIN R U-500)
1000 Units given intranasally.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Mild hypoglycemia [600 units]
|
0.00%
0/4 • Up to 61 days
|
0.00%
0/14 • Up to 61 days
|
0.00%
0/24 • Up to 61 days
|
0.00%
0/1 • Up to 61 days
|
4.3%
1/23 • Up to 61 days
|
0.00%
0/22 • Up to 61 days
|
0.00%
0/5 • Up to 61 days
|
0.00%
0/22 • Up to 61 days
|
|
Endocrine disorders
Severe hypoglycemia [600 units]
|
0.00%
0/4 • Up to 61 days
|
0.00%
0/14 • Up to 61 days
|
0.00%
0/24 • Up to 61 days
|
0.00%
0/1 • Up to 61 days
|
4.3%
1/23 • Up to 61 days
|
0.00%
0/22 • Up to 61 days
|
0.00%
0/5 • Up to 61 days
|
0.00%
0/22 • Up to 61 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place