Trial Outcomes & Findings for Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia (NCT NCT01462227)
NCT ID: NCT01462227
Last Updated: 2016-02-18
Results Overview
Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
End of study (up to 240 minutes)
Results posted on
2016-02-18
Participant Flow
Participant milestones
| Measure |
Naltrexone (Lower Dose) First /Placebo Second
Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
|
Placebo First/ Naltrexone (Lower Dose) Second
Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
|
Naltrexone (Higher Dose) First /Placebo Second
Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
|
Placebo First / Naltrexone (Higher Dose) Second
Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
|
|---|---|---|---|---|
|
First Assignment
STARTED
|
4
|
2
|
6
|
5
|
|
First Assignment
COMPLETED
|
4
|
2
|
6
|
5
|
|
First Assignment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Assignment
STARTED
|
4
|
2
|
6
|
5
|
|
Second Assignment
COMPLETED
|
3
|
1
|
5
|
5
|
|
Second Assignment
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Naltrexone (Lower Dose) First /Placebo Second
Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
|
Placebo First/ Naltrexone (Lower Dose) Second
Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
|
Naltrexone (Higher Dose) First /Placebo Second
Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
|
Placebo First / Naltrexone (Higher Dose) Second
Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
|
|---|---|---|---|---|
|
Second Assignment
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Second Assignment
Protocol Violation
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
Baseline characteristics by cohort
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
|
Naltrexone (Higher Dose)
n=10 Participants
Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 11 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 12 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of study (up to 240 minutes)Population: Subjects' data were pooled and only those that completed both visits are analyzed here.
Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Outcome measures
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
Naltrexone (Higher Dose)
n=10 Participants
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
|---|---|---|
|
Glucose (mg/dL)
Placebo
|
55.0 mg/dL
Standard Deviation 2.8
|
52.8 mg/dL
Standard Deviation 8.6
|
|
Glucose (mg/dL)
Active Drug
|
56.5 mg/dL
Standard Deviation 3.7
|
52.8 mg/dL
Standard Deviation 8.6
|
PRIMARY outcome
Timeframe: End of study (up to 240 minutes)Population: Subjects' data were pooled and only those that completed both visits are analyzed here.
The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).
Outcome measures
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
Naltrexone (Higher Dose)
n=10 Participants
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
|---|---|---|
|
Glucose Infusion Rate (mg/kg.Min)
Active Drug
|
4.6 mg/kg.min
Standard Deviation 2.7
|
6.3 mg/kg.min
Standard Deviation 2.4
|
|
Glucose Infusion Rate (mg/kg.Min)
Placebo
|
4.8 mg/kg.min
Standard Deviation 4.0
|
5.9 mg/kg.min
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: End of study (up to 240 minutes)Population: Subjects' data were pooled and only those that completed both visits are analyzed here.
Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Outcome measures
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
Naltrexone (Higher Dose)
n=10 Participants
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
|---|---|---|
|
Glucagon (pg/mL)
Active Drug
|
44.1 pg/mL
Standard Deviation 17.4
|
48.9 pg/mL
Standard Deviation 16.5
|
|
Glucagon (pg/mL)
Placebo
|
40.4 pg/mL
Standard Deviation 7.9
|
53.6 pg/mL
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: End of study (up to 240 minutes)Population: Subjects' data were pooled and only those that completed both visits are analyzed here.
Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Outcome measures
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
Naltrexone (Higher Dose)
n=10 Participants
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
|---|---|---|
|
Cortisol (ug/dL)
Active Drug
|
22.9 ug/dL
Standard Deviation 8.3
|
16.4 ug/dL
Standard Deviation 8.1
|
|
Cortisol (ug/dL)
Placebo
|
16.0 ug/dL
Standard Deviation 7.0
|
15.2 ug/dL
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: End of study (up to 240 minutes)Population: Subjects' data were pooled and only those that completed both visits are analyzed here.
Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Outcome measures
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
Naltrexone (Higher Dose)
n=10 Participants
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
|---|---|---|
|
Epinephrine (pg/mL)
Active Drug
|
92.75 pg/mL
Standard Deviation 30.6
|
126.1 pg/mL
Standard Deviation 98.0
|
|
Epinephrine (pg/mL)
Placebo
|
42.75 pg/mL
Standard Deviation 23.1
|
77.9 pg/mL
Standard Deviation 65.8
|
SECONDARY outcome
Timeframe: End of study (up to 240 minutes)Population: Subjects' data were pooled and only those that completed both visits are analyzed here.
Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Outcome measures
| Measure |
Naltrexone (Lower Dose)
n=4 Participants
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
Naltrexone (Higher Dose)
n=10 Participants
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
|
|---|---|---|
|
Norepinephrine (pg/mL)
Active Drug
|
248.3 pg/mL
Standard Deviation 80.2
|
200.1 pg/mL
Standard Deviation 77.4
|
|
Norepinephrine (pg/mL)
Placebo
|
282.8 pg/mL
Standard Deviation 97.3
|
217.1 pg/mL
Standard Deviation 91.5
|
Adverse Events
Naltrexone (50 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Lower Dose Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naltrexone (100 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Higher Dose)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone (50 mg)
n=4 participants at risk
Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
|
Placebo (Lower Dose Group)
n=4 participants at risk
Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
|
Naltrexone (100 mg)
n=10 participants at risk
Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
|
Placebo (Higher Dose)
n=10 participants at risk
Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • End of study, up to 240 minutes.
|
0.00%
0/4 • End of study, up to 240 minutes.
|
50.0%
5/10 • Number of events 5 • End of study, up to 240 minutes.
|
20.0%
2/10 • Number of events 2 • End of study, up to 240 minutes.
|
|
General disorders
Insomnia
|
0.00%
0/4 • End of study, up to 240 minutes.
|
0.00%
0/4 • End of study, up to 240 minutes.
|
0.00%
0/10 • End of study, up to 240 minutes.
|
10.0%
1/10 • Number of events 1 • End of study, up to 240 minutes.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place