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NCT05662332 · ClinicalTrials.gov registry record · Phase 3
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
A Phase 3 study of Type 2 Diabetes and T2D, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 795
- Enrollment target
- 20
- Study locations
NCT05662332: Completed Phase 3 study of Type 2 Diabetes and T2D, sponsored by Eli Lilly and Company.
NCT05662332 is a Phase 3 study of Type 2 Diabetes and T2D that has completed, run by Eli Lilly and Company. The registered enrollment target is 795 participants, below the 3,921-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05662332, a Phase 3 study of Type 2 Diabetes and T2D, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 795 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
Primary Outcome
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.
Conditions Studied
Interventions
- DRUG Insulin Glargine
- DRUG Insulin Efsitora Alfa
Study Locations (20)
California
- AMCR Institute - Escondido
- Velocity Clinical Research, Gardena - Gardena
- National Research Institute - Huntington Park - Huntington Park
- National Research Institute - Wilshire - Los Angeles
- Diabetes Associates Medical Group - Orange
- Encompass Clinical Research - Spring Valley
- Millennium Clinical Trials - Thousand Oaks
- University Clinical Investigators, Inc. - Tustin
- Diablo Clinical Research, Inc. - Walnut Creek
Florida
- Clinical Research of West Florida, Inc. (Clearwater) - Clearwater
- Suncoast Research Group - Miami
- Clinical Research of West Florida - Tampa
Alabama
- Cahaba Research - Birmingham
- Syed Research Consultants Llc - Sheffield
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Connecticut
- Chase Medical Research, LLC - Waterbury
Georgia
- Center for Advanced Research & Education - Gainesville
Hawaii
- Pacific Diabetes & Endocrine Center - Honolulu
Illinois
- Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 795 participants |
| Start Date | 2023-01-14 |
| Est. Completion | 2024-07-19 |
| Phase | Phase 3 |
What the finished NCT05662332 record still lists
NCT05662332 is an interventional study that assigns participants to a tested intervention. The registered 795 participants enrollment target is mid-sized for trials with a published cap, below the 3,921-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Insulin Glargine is the first listed.
NCT05662332 names 20 study sites across 9 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05662332 about?
NCT05662332 is a clinical study titled "A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)". The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
What is the current status of trial NCT05662332?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 795 participants. The study started on 2023-01-14. Estimated completion is 2024-07-19.
What conditions does trial NCT05662332 study?
This clinical trial studies the following conditions: Type 2 Diabetes, T2D.
What interventions are being tested in trial NCT05662332?
The interventions under investigation include: Insulin Glargine (DRUG), Insulin Efsitora Alfa (DRUG).
Who is sponsoring clinical trial NCT05662332?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05662332 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. 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 NCT05662332's enrollment target sits among peer trials
795 32nd of 327 higher than 296 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 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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