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NCT05362058 · ClinicalTrials.gov registry record · Phase 3
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
A Phase 3 study of Diabetes and Type 2 Diabetes, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 928
- Enrollment target
- 20
- Study locations
NCT05362058: Completed Phase 3 study of Diabetes and Type 2 Diabetes, sponsored by Eli Lilly and Company.
NCT05362058 is a Phase 3 study of Diabetes and Type 2 Diabetes that has completed, run by Eli Lilly and Company. The registered enrollment target is 928 participants, below the 3,025-participant average among 338 other Diabetes trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362058, a Phase 3 study of Diabetes and Type 2 Diabetes, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 928 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.
Primary Outcome
* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. * Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.
Conditions Studied
Interventions
- DRUG Insulin Degludec
- DRUG Insulin Efsitora Alfa
Study Locations (20)
California
- Neighborhood Healthcare Institute of Health - Escondido
- Valley Research - Fresno
- NorCal Medical Research, Inc - Greenbrae
- Catalina Research Institute, LLC - Montclair
- Southern California Dermatology, Inc. - Santa Ana
Georgia
- East Coast Institute for Research - Canton - Canton
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City
Maryland
- MedStar Health Research Institute (MedStar Physician Based Research Network) - Hyattsville
- Endocrine and Metabolic Consultants - Rockville
New York
- Clarity Clinical Research - East Syracuse
- Great Lakes Medical Research, LLC - Westfield
Colorado
- New West Physicians Clinical Research - Golden
Connecticut
- New England Research Associates, LLC - Bridgeport
Florida
- East Coast Institute for Research, LLC - Jacksonville
Illinois
- Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 928 participants |
| Start Date | 2022-06-03 |
| Est. Completion | 2024-04-10 |
| Phase | Phase 3 |
What the finished NCT05362058 record still lists
NCT05362058 is an interventional study that assigns participants to a tested intervention. The registered 928 participants enrollment target is mid-sized for trials with a published cap, below the 3,025-participant average among 338 other Diabetes trials with a reported enrollment target (69% 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.
NCT05362058 names 20 study sites across 13 states, led by California, Georgia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05362058 about?
NCT05362058 is a clinical study titled "A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time". The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week ...
What is the current status of trial NCT05362058?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 928 participants. The study started on 2022-06-03. Estimated completion is 2024-04-10.
What conditions does trial NCT05362058 study?
This clinical trial studies the following conditions: Diabetes, Type 2 Diabetes.
What interventions are being tested in trial NCT05362058?
The interventions under investigation include: Insulin Degludec (DRUG), Insulin Efsitora Alfa (DRUG).
Who is sponsoring clinical trial NCT05362058?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05362058 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. 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 NCT05362058's enrollment target sits among peer trials
928 45th of 338 higher than 294 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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