NCT02700048

Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators intend to enroll 18 individuals to obtain the complete data sets from 15 participants. Expected duration of subject participation is 10-12 weeks. This study will consist of two 2-day intervention visits separated by approximately 8 weeks.

Detailed description

This is a single center, single-blinded randomized cross over design trial, that will compare the impact of IN naloxone vs. IN saline during experimental hypoglycemia on day one on the responses to experimental hypoglycemia on day two. 18 participants will be studied twice, 8 weeks apart. On each occasion participants will undergo a 2 hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the morning of day 2. During the morning clamps, samples will be collected for later measurement of serum epinephrine, glucagon and cortisol levels and participants will be asked to complete a hypoglycemia symptom questionnaire. 3 intranasal doses (4 mg each) of naloxone hydrochloride or IN saline will be administered to the subject on day 1. Plasma will be collected for measurement of naloxone concentrations on day 1 primary outcome is the difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two, thus each participant will have two observations: one from their naloxone experiment and one from their saline experiment. Secondary endpoint will be naloxone pharmacokinetics including maximum concentration (Cmax), time to maximum concentration (Tmax) and area under the curve (AUC)

Conditions

• Hypoglycemia Unawareness
• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	intra-nasal naloxone	3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
DRUG	Intra-nasal saline	3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2016-03-07
• Last updated: 2023-03-27
• Results posted: 2023-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study