| Trial ID: | L1797 |
| Source ID: | NCT02700048
|
| Associated Drug: |
Intra-Nasal Naloxone
|
| Title: |
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02700048/results
|
| Conditions: |
Hypoglycemia Unawareness|Type 1 Diabetes
|
| Interventions: |
DRUG: intra-nasal naloxone|DRUG: Intra-nasal saline
|
| Outcome Measures: |
Primary: Within Person Difference in Peak Epinephrine During Hypoglycemia, 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, 2 years | Secondary: Naloxone Pharmacokinetics, maximum concentration (Cmax), 2 year|Naloxone Pharmacokinetics, area under the curve (AUC), 2 year
|
| Sponsor/Collaborators: |
Sponsor: University of Minnesota
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
|
| Start Date: |
2016-06
|
| Completion Date: |
2021-07
|
| Results First Posted: |
2023-03-27
|
| Last Update Posted: |
2023-03-27
|
| Locations: |
Clinical and Translational Science Institute, University of Minnesota, Minneapolis, Minnesota, 55446, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02700048
|
