Trial Outcomes & Findings for Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon (NCT NCT02516150)
NCT ID: NCT02516150
Last Updated: 2017-08-31
Results Overview
Area over the curve for the glucose infusion rate in the hour following a subcutaneous glucagon dose with a blood alcohol content of 0 vs 0.1%
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
1 Day Visit (approximately 8 to 11 hours)
Results posted on
2017-08-31
Participant Flow
26 subjects were enrolled. 8 subjects were ineligible to participate, 1 subject withdrew consent, and 2 subjects were not able to be scheduled to participate. 15 subjects participated in both visits.
Participant milestones
| Measure |
All Subjects
All subjects enrolled
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
Baseline characteristics by cohort
| Measure |
All Subjects
n=15 Participants
All subjects enrolled
|
|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Diabetes Duration
|
28.4 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 Day Visit (approximately 8 to 11 hours)Area over the curve for the glucose infusion rate in the hour following a subcutaneous glucagon dose with a blood alcohol content of 0 vs 0.1%
Outcome measures
| Measure |
Glucagon With Ethanol
n=15 Participants
Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.
Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
Glucagon: injection of 50 micrograms of glucagon
|
Glucagon Without Ethanol
n=15 Participants
Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.
Glucagon: injection of 50 micrograms of glucagon
|
|---|---|---|
|
AOCGIR (Area Over the Curve for Glucose Infusion Rate)
|
1996 mg*minute/dl
Standard Deviation 1259
|
1981 mg*minute/dl
Standard Deviation 938
|
SECONDARY outcome
Timeframe: 1 Day Visit (approximately 8 to 11 hours)This outcome is measuring the maximum change in the glucose infusion rate from the GIR at the time of the injection through the 90 minutes after the glucagon injection in the presence and absence of ethanol. The glucose infusion rate is adjusted up to every two minutes throughout the clamp, and for 90 minutes total after the glucagon injection.
Outcome measures
| Measure |
Glucagon With Ethanol
n=15 Participants
Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.
Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
Glucagon: injection of 50 micrograms of glucagon
|
Glucagon Without Ethanol
n=15 Participants
Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.
Glucagon: injection of 50 micrograms of glucagon
|
|---|---|---|
|
Maximum Change in GIR (Glucose Infusion Rate) From Baseline
|
83.0 ml/hour
Standard Deviation 35.2
|
101.7 ml/hour
Standard Deviation 38.8
|
Adverse Events
Glucagon With Ethanol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Glucagon Without Ethanol
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 |
Glucagon With Ethanol
n=15 participants at risk
Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection.
Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
Glucagon: injection of 50 micrograms of glucagon
|
Glucagon Without Ethanol
n=15 participants at risk
Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection.
Glucagon: injection of 50 micrograms of glucagon
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
0.00%
0/15 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
|
Cardiac disorders
Chest tightness
|
6.7%
1/15 • Number of events 1 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
0.00%
0/15 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
0.00%
0/15 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
|
Nervous system disorders
Blurred vision/dizziness
|
6.7%
1/15 • Number of events 1 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
0.00%
0/15 • Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place