drugset / Trial / NCT02700048

Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

NCT02700048

Phase 1/2 Terminated 11 enrolled University of Minnesota
RandomizedCrossoverSingle-blindPrevention

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.

Timeline

Start
2016-06
Primary completion
2021-07
Completion
2021-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 4 mg Intranasal