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)
NCT ID: NCT05662332
Last Updated: 2025-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
795 participants
INTERVENTIONAL
2023-01-14
2024-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin Efsitora Alfa
Participants 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 Efsitora Alfa
Administered SC
Insulin Glargine
Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
Insulin Glargine
Administered SC
Interventions
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Insulin Efsitora Alfa
Administered SC
Insulin Glargine
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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%.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Cahaba Research
Birmingham, Alabama, United States
Syed Research Consultants Llc
Sheffield, Alabama, United States
AMCR Institute
Escondido, California, United States
Velocity Clinical Research, Gardena
Gardena, California, United States
National Research Institute - Huntington Park
Huntington Park, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
Diabetes Associates Medical Group
Orange, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Millennium Clinical Trials
Thousand Oaks, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, United States
American Health Network of Indiana, LLC - Franklin
Franklin, Indiana, United States
American Health Network of Indiana, LLC - Muncie
Muncie, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Clinvest Research LLC
Springfield, Missouri, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Meridian Clinical Research, LLC
Vestal, New York, United States
Intend Research, LLC
Norman, Oklahoma, United States
Decpa, Llc
Feasterville-Trevose, Pennsylvania, United States
Office 18
Pittsburgh, Pennsylvania, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, United States
Private Practice - Dr. Osvaldo A. Brusco
Corpus Christi, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Prime Revival Research Institute
Flower Mound, Texas, United States
Endocrine Associates
Houston, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Eastside Research Associates
Redmond, Washington, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
DIM Clínica Privada
Ramos Mejía, Buenos Aires, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, Buenos Air, Argentina
Stat Research S.A.
Buenos Aires, Ciudad Aut, Argentina
Centro Médico Viamonte
Buenos Aires, Ciudad Aut, Argentina
Glenny Corp
Buenos Aires, Ciudad Aut, Argentina
CEMEDIAB
C.a.b.a., Ciudad Aut, Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
CIPREC
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina
Centro Medico Privado San Vicente Diabetes
Córdoba, Córdoba Province, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Mendoza Province, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, Argentina
Clínica Mayo
San Miguel de Tucumán, Tucumán Province, Argentina
Fundación Respirar
Buenos Aires, , Argentina
CENUDIAB
Ciudad Autónoma de Buenos Aire, , Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, , Argentina
Sanatorio Norte
Santiago del Estero, , Argentina
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, Mexico
RM Pharma Specialists
Mexico City, Mexico City, Mexico
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Nuevo León, Mexico
Medical Care and Research SA de CV
Mérida, Yucatán, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, , Mexico
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
Countries
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References
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Rosenstock 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Other Identifiers
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I8H-MC-BDCW
Identifier Type: OTHER
Identifier Source: secondary_id
18261
Identifier Type: -
Identifier Source: org_study_id
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