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NCT01994746 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults
A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
- 8
- Study locations
NCT01994746: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.
NCT01994746 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Eli Lilly and Company. The registered enrollment target is 77 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01994746, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally compared with commercially available glucagon given by intramuscular injection.
Primary Outcome
Increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level defines treatment success. Due to the residual activity of circulating insulin, glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes following glucagon administration.
Conditions Studied
Interventions
- DRUG Nasal Glucagon
- DRUG Intramuscular Glucagon
Study Locations (8)
Colorado
- Barbara Davis Center for Diabetes - Aurora
Connecticut
- Yale University - New Haven
Florida
- University of Florida - Gainesville
Indiana
- Riley Hospital for Children Indiana University Health - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
New York
- UPA Buffalo - Buffalo
Oregon
- Oregon Health and Science University - Portland
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01994746 record still lists
NCT01994746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Nasal Glucagon is the first listed.
NCT01994746 lists 8 locations in 8 states (Colorado, Connecticut, Florida).
Frequently Asked Questions
What is clinical trial NCT01994746 about?
NCT01994746 is a clinical study titled "Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults". The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally compared with commercially available glucagon given by intramuscular injection.
What is the current status of trial NCT01994746?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2013-11. Estimated completion is 2015-01.
What conditions does trial NCT01994746 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT01994746?
The interventions under investigation include: Nasal Glucagon (DRUG), Intramuscular Glucagon (DRUG).
Who is sponsoring clinical trial NCT01994746?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01994746 being conducted?
This trial has 8 study locations across Colorado, Connecticut, Florida, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01994746's enrollment target sits among peer trials
77 58th of 118 higher than 61 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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