CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 99 enrolled
Drug / intervention
IM Glucagon +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03765502
NCT03765502Phase 1Completed
CompareCT.gov

A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon

Eli Lilly and Company·interventional·Posted Dec 5, 2018·Updated Mar 20, 2020

In Brief

A Phase 1 clinical trial evaluating Nasal Glucagon Device (NG), GEK, and 1 other intervention for Healthy. Completed, enrolled 99 participants across 1 site.

Detailed Summary

The purpose of the study is to learn more about different devices for delivering glucagon during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be carried out using medical manikins to simulate real life scenarios. No drug will be administered to humans. Part A will last approximately 17 days for Trained Users and Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained Users. Each part will be separated by approximately 7 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedDec 5, 2018
Enrollment StartNov 19, 2018
Primary CompletionJan 3, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.6 years ago

Interventions

Nasal Glucagon Device (NG)device

NG devices will be provided empty of drug product

GEKdevice

Used to administer glucagon intramuscularly (IM)

IM Glucagondrug

Administered IM via GEK