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)
QWINT-1
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes
2 other identifiers
interventional
795
4 countries
71
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Jan 2023
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedStudy Start
First participant enrolled
January 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2024
CompletedResults Posted
Study results publicly available
August 6, 2025
CompletedAugust 6, 2025
July 1, 2025
1.5 years
December 15, 2022
July 19, 2025
July 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]
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.
Baseline, Week 52
Secondary Outcomes (13)
Change From Baseline in HbA1c [Superiority]
Baseline, Week 52
Change From Baseline in Fasting Glucose
Baseline, Week 52
Basal Insulin Dose at Week 52
Week 52
Rate Per Year of Hypoglycemia Events
Baseline up to Week 52
Percentage of Participants With Hypoglycemia Events (Incidence)
Week 52
- +8 more secondary outcomes
Study Arms (2)
Insulin Efsitora Alfa
EXPERIMENTALParticipants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
Insulin Glargine
ACTIVE COMPARATORParticipants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have a diagnosis of T2D according to the World Health Organization criteria.
- Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
- Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
- Are insulin naive
- Exceptions:
- short-term insulin treatment for a maximum of 14 days, prior to screening, and
- prior insulin treatment for gestational diabetes.
You may not qualify if:
- Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
- Have a history of \>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
- Have had severe hypoglycemia episodes within 6 months prior to screening.
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- coronary bypass surgery.
- Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
- Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Cahaba Research
Birmingham, Alabama, 35242, United States
Syed Research Consultants Llc
Sheffield, Alabama, 35660, United States
AMCR Institute
Escondido, California, 92025, United States
Velocity Clinical Research, Gardena
Gardena, California, 90247, United States
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
Diabetes Associates Medical Group
Orange, California, 92868, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Millennium Clinical Trials
Thousand Oaks, California, 93065, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
Suncoast Research Group
Miami, Florida, 33135, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
American Health Network of Indiana, LLC - Franklin
Franklin, Indiana, 46131, United States
American Health Network of Indiana, LLC - Muncie
Muncie, Indiana, 47304, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198-4130, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
Meridian Clinical Research, LLC
Vestal, New York, 13850, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Decpa, Llc
Feasterville-Trevose, Pennsylvania, 19053, United States
Office 18
Pittsburgh, Pennsylvania, 15236, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Private Practice - Dr. Osvaldo A. Brusco
Corpus Christi, Texas, 78414, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Prime Revival Research Institute
Flower Mound, Texas, 75028, United States
Endocrine Associates
Houston, Texas, 77004, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
DIM Clínica Privada
Ramos Mejía, Buenos Aires, 1704, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, Buenos Air, C1419AHN, Argentina
Stat Research S.A.
Buenos Aires, Ciudad Aut, C1023AAB, Argentina
Centro Médico Viamonte
Buenos Aires, Ciudad Aut, C1120AAC, Argentina
Glenny Corp
Buenos Aires, Ciudad Aut, C1430CKE, Argentina
CEMEDIAB
C.a.b.a., Ciudad Aut, C1205AAO, Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, Ciudad Autónoma de Buenos Aire, C1056ABH, Argentina
CIPREC
Buenos Aires, Ciudad Autónoma de Buenos Aire, C1061AAS, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1425AGC, Argentina
Centro Medico Privado San Vicente Diabetes
Córdoba, Córdoba Province, 5006, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, 5800, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Mendoza Province, M5501ARP, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, 2000, Argentina
Clínica Mayo
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
CENUDIAB
Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000, Argentina
Sanatorio Norte
Santiago del Estero, 4200, Argentina
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, 04460, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, 44130, Mexico
RM Pharma Specialists
Mexico City, Mexico City, 03100, Mexico
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, 62250, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Nuevo León, 66465, Mexico
Medical Care and Research SA de CV
Mérida, Yucatán, 97070, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, 31217, Mexico
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Related Publications (2)
Miller E, Davidson MB, Bajaj HS, Rosenstock J, Philis-Tsimikis A, Bergenstal RM, Case M, Ilag L, Threlkeld R, Levasseur E, Gelsey F. Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program. Diabetes Ther. 2026 Jan 27. doi: 10.1007/s13300-025-01833-5. Online ahead of print.
PMID: 41591636DERIVEDRosenstock J, Bailey T, Connery L, Miller E, Desouza C, Wang Q, Leohr J, Knights A, Carr MC, Child CJ; QWINT-1 trial investigators. Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. 2025 Jul 24;393(4):325-335. doi: 10.1056/NEJMoa2502796. Epub 2025 Jun 22.
PMID: 40548694DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Sponsor will be blinded throughout the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2022
First Posted
December 22, 2022
Study Start
January 14, 2023
Primary Completion
July 19, 2024
Study Completion
July 19, 2024
Last Updated
August 6, 2025
Results First Posted
August 6, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the United States (US) and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.