A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections
NCT ID: NCT05462756
Last Updated: 2025-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
730 participants
INTERVENTIONAL
2022-08-11
2024-02-27
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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500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC with meals as needed.
Insulin Efsitora Alfa
Administered SC
Insulin Lispro (U100)
Administered SC
100 U/mL - Insulin Glargine
Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed.
Insulin Lispro (U100)
Administered SC
Insulin Glargine (U100)
Administered SC
Interventions
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Insulin Efsitora Alfa
Administered SC
Insulin Lispro (U100)
Administered SC
Insulin Glargine (U100)
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are receiving ≥10 units of total basal insulin per day at screening.
* Are receiving ≤2 units/kilogram/day of total daily insulin at screening
* Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
* Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
* once daily U-100 or U-200 insulin degludec
* once daily U-100 or U-300 insulin glargine
* once or twice daily U-100 insulin detemir or
* once or twice daily human insulin Neutral Protamine Hagedorn
* Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
* Insulin lispro-aabc
* Insulin lispro (U-100 and U-200)s, IN\], U-100 or U200)
* Insulin aspart (U-100)
* Insulin glulisine (U-100), or
* Regular insulin (U-100)
* Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
* dipeptidyl peptidase IV inhibitors
* sodium-glucose co-transporter-2 inhibitors
* biguanides (for example, metformin), or
* glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
* Have a body mass index ≤45 kilogram/square meter (kg/m²)
Exclusion Criteria
* Are currently receiving any of the following insulin therapies anytime in the past 90 days:
* insulin mixtures
* insulin human, inhalation powder, or
* continuous subcutaneous insulin infusion therapy, or
* regular insulin U-500
* Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
* Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
* Have hypoglycemia unawareness in the opinion of the investigator
* Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
* Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
* Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening
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) 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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CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Palm Research Center Sunset
Las Vegas, Nevada, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, United States
Remington Davis Clinical Research
Columbus, Ohio, United States
Aventiv Research
Dublin, Ohio, United States
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Research Institute of Dallas
Plano, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Rainier Clinical Research Center
Renton, Washington, United States
CEDIC
CABA, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, Argentina
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., Argentina
CIPREC
CABA, Buenos Aires F.D., Argentina
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina
Instituto Centenario
CABA, 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
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, Argentina
Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta
Rosario, Santa Fe Province, Argentina
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
CENUDIAB
Buenos Aires, , Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, , Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe, , Argentina
ClinPhenomics GmbH & Co KG
Frankfurt am Main, Hesse, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, Germany
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
Münster, North Rhine-Westphalia, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabetespraxis Mergentheim
Bad Mergentheim, , Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Life Care Hospital and Research Centre
Bangalore, Karnataka, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, India
BSES MG Hospital
Mumbai, Maharashtra, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, India
Osmania General Hospital
Hyderabad, Telangana, India
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh, , India
Osepdale Civile Fr 5
Ceccano, Frosinone, Italy
"Fatebenefratelli Isola Tiberina - Gemelli Isola"
Rome, Lazio, Italy
Ospedale san Giovanni di Dio-Diabetologia
Olbia, Sardinia, Italy
INRCA Ancona
Ancona, , Italy
IRCCS - AOU di Bologna
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Azienda Ospedaliera Mater Domini
Catanzaro, , Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, , Italy
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, 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
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, Tamaulipas, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, , Mexico
Centro de Endocrinologia Alcantara Gonzalez
Bayamón, , Puerto Rico
Manati Center for Clinical Research
Manatí, , Puerto Rico
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitari Son Espases
Palma, Balears [Baleares], Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Vithas Hospital Sevilla
Seville, Sevilla, Spain
Hospital Universitario de La Ribera
Alzira, Valenciana, Comunitat, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario San Cecilio
Granada, , Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, , Spain
Countries
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References
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Blevins T, Dahl D, Perez Manghi FC, Murthy S, Ortiz Carrasquillo R, Li X, Chang AM, Carr MC, Katz M. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2290-2301. doi: 10.1016/S0140-6736(25)01069-4. 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 as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)
Other Identifiers
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I8H-MC-BDCV
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005878-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18260
Identifier Type: -
Identifier Source: org_study_id
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