Trial Outcomes & Findings for Naloxone, Hypoglycemia and Exercise (NCT NCT03149770)

Last Updated: 2024-04-16

Results Overview

The primary outcome variable for Aim 1 will be the difference, naloxone vs. saline, in symptom scores collected using a standard questionnaire during the hypoglycemic clamp on Day 2, after administration of intranasal treatment during exercise on Day 1. the scale for symptoms score is 0-72. A higher score represents a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Day 2

Results posted on

2024-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Naloxone First, Then Placebo Naloxone, then placebo Naloxone then placebo: naloxone intranasal 4mg, then placebo	Placebo First, Then Naloxone Placebo, then Naloxone Placebo then Naloxone: placebo then naloxone intranasal 4mg
Overall Study STARTED	16	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naloxone, Hypoglycemia and Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=16 Participants Naloxone, then placebo Naloxone then placebo: naloxone intranasal 4mg, then placebo	Arm 2 n=14 Participants Placebo, then Naloxone Placebo then Naloxone: placebo then naloxone intranasal 4mg	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2

Outcome measures

Outcome measures
Measure	Naloxone n=28 Participants naloxone intranasal 4mg	Placebo n=26 Participants Participants receiving placebo
Change in Symptom Score	25 score on a scale Standard Deviation 12	21 score on a scale Standard Deviation 13

PRIMARY outcome

Timeframe: Day 2

The primary outcome variable for Aim 2 will be the difference, naloxone vs. saline, in peak epinephrine levels measured during the hypoglycemic clamp on Day 2, after administration of treatment during exercise on Day 1.

Outcome measures

Outcome measures
Measure	Naloxone n=28 Participants naloxone intranasal 4mg	Placebo n=26 Participants Participants receiving placebo
Change in Epinephrine Levels	425 pg/ml Standard Deviation 236	367 pg/ml Standard Deviation 228

Adverse Events

Naloxone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naloxone n=28 participants at risk naloxone intranasal 4mg	Placebo n=26 participants at risk Participants receiving placebo
Gastrointestinal disorders Nausea/vomiting	7.1% 2/28 • Number of events 2 • 3-6 months	0.00% 0/26 • 3-6 months
General disorders headache	7.1% 2/28 • Number of events 2 • 3-6 months	0.00% 0/26 • 3-6 months
General disorders fatigue/tiredness	0.00% 0/28 • 3-6 months	7.7% 2/26 • Number of events 2 • 3-6 months

Additional Information

Anjali Kumar

University of Minnesota

Phone: 612-301-7040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place