Trial Outcomes & Findings for Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia (NCT NCT02700048)

NCT ID: NCT02700048

Last Updated: 2023-03-27

Results Overview

Primary endpoint will be the within person difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two; investigators will compare this difference between the two treatment conditions

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2023-03-27

Participant Flow

11 participants consented, but only 3 actually started the trial

Participant milestones

Measure	Placebo 3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps Intra-nasal saline: 3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps	Treatment With Intra-nasal Naloxone 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps intra-nasal naloxone: 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Overall Study STARTED	0	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Placebo 3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps Intra-nasal saline: 3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps	Treatment With Intra-nasal Naloxone 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps intra-nasal naloxone: 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
Overall Study The device failed so the study wasn't completed and participants were dropped	0	3

Baseline Characteristics

Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 years

Population: the device failed so data was not collected and participants dropped

Primary endpoint will be the within person difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two; investigators will compare this difference between the two treatment conditions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 year

Population: the device failed so data was not collected and participants dropped

maximum concentration (Cmax)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 year

Population: the device failed so data was not collected and participants dropped

area under the curve (AUC)

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment With Intra-nasal Naloxone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amir Moheet

University of Minnesota

Phone: 6126249990

Email: mohee002@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place