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NCT05463744 · ClinicalTrials.gov registry record · Phase 3
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
A Phase 3 study of Diabetes and Type 1 Diabetes, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 692
- Enrollment target
- 20
- Study locations
NCT05463744: Completed Phase 3 study of Diabetes and Type 1 Diabetes, sponsored by Eli Lilly and Company.
NCT05463744 is a Phase 3 study of Diabetes and Type 1 Diabetes that has completed, run by Eli Lilly and Company. The registered enrollment target is 692 participants, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05463744, a Phase 3 study of Diabetes and Type 1 Diabetes, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 692 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
Primary Outcome
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with treatment + country + CGM use prior to study entry \[yes/no\]+ carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-
Conditions Studied
Interventions
- DRUG Insulin Degludec
- DRUG Insulin Efsitora Alfa
Study Locations (20)
California
- John Muir Physician Network Research Center - Concord
- Valley Research - Fresno
- Catalina Research Institute, LLC - Montclair
- Sansum Diabetes Research Institute - Santa Barbara
- University Clinical Investigators, Inc. - Tustin
Florida
- Northeast Research Institute (NERI) - Fleming Island
- Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care - Fort Lauderdale
- Suncoast Clinical Research, Inc. - New Port Richey
- Hanson Clinical Research Center - Port Charlotte
Maryland
- MedStar Health Research Institute (MedStar Physician Based Research Network) - Hyattsville
- Endocrine and Metabolic Consultants - Rockville
Nevada
- Palm Research Center Tenaya - Las Vegas
- Palm Research Center Sunset - Las Vegas
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Georgia
- East Coast Institute for Research at The Jones Center - Macon
Hawaii
- East-West Medical Research Institute - Honolulu
Idaho
- Rocky Mountain Clinical Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 692 participants |
| Start Date | 2022-08-12 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 3 |
What the finished NCT05463744 record still lists
NCT05463744 is an interventional study that assigns participants to a tested intervention. The registered 692 participants enrollment target is mid-sized for trials with a published cap, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Insulin Degludec is the first listed.
NCT05463744 names 20 study sites across 11 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT05463744 about?
NCT05463744 is a clinical study titled "A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy". The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
What is the current status of trial NCT05463744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 692 participants. The study started on 2022-08-12. Estimated completion is 2024-05-07.
What conditions does trial NCT05463744 study?
This clinical trial studies the following conditions: Diabetes, Type 1 Diabetes.
What interventions are being tested in trial NCT05463744?
The interventions under investigation include: Insulin Degludec (DRUG), Insulin Efsitora Alfa (DRUG).
Who is sponsoring clinical trial NCT05463744?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05463744 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05463744's enrollment target sits among peer trials
692 58th of 338 higher than 281 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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.
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