A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
3 other identifiers
interventional
986
10 countries
127
Brief Summary
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.
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 Mar 2022
Typical duration for phase_3 type-2-diabetes
127 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
March 3, 2022
CompletedStudy Start
First participant enrolled
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2024
CompletedResults Posted
Study results publicly available
June 3, 2025
CompletedJune 3, 2025
May 1, 2025
2.2 years
March 3, 2022
May 15, 2025
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
Baseline, Week 26
Secondary Outcomes (13)
Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]
Baseline, Week 26
Nocturnal Hypoglycemia Event Rate
Baseline up to Week 78
Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L)
Week 22 to Week 26
Change From Baseline in Fasting Glucose
Baseline, Week 26
Weekly Insulin Dose at Week 26
Week 26
- +8 more secondary outcomes
Study Arms (2)
500 U/mL - Insulin Efsitora
EXPERIMENTALParticipants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
100 U/mL - Insulin Degludec
ACTIVE COMPARATORParticipants received 100 U/mL insulin degludec administered SC once daily (QD).
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
- Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
- Have HbA1c value of 6.5% - 10% inclusive, at screening
- Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
- Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
- once daily U100 or U200 of insulin degludec
- once daily U100 or U300 of insulin glargine
- once or twice daily U100 of insulin detemir, or
- once or twice daily human insulin NPH
- acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
- dipeptidyl peptidase (DPP-4) IV inhibitors
- SGLT2 inhibitors
- metformin
- alphaglucosidase inhibitors or,
- Glucagon-Like Peptide-1 (GLP-1) receptor agonists
- +1 more criteria
You may not qualify if:
- Have Type 1 diabetes mellitus
- Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
- Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
- Have active or untreated malignancy
- Are pregnant
- Have a significant weight gain or loss the past 3 months
- Have received anytime in the past 6 months, any of the following insulin therapies:
- prandial insulin
- insulin mixtures
- inhaled insulin
- U-500 insulin, or
- continuous subcutaneous insulin infusion therapy
- Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
- acute myocardial infarctions
- cerebrovascular accident (stroke), or
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
Medical Investigations
Little Rock, Arkansas, 72211, United States
John Muir Physician Network Research Center
Concord, California, 94520, United States
AMCR Institute
Escondido, California, 92025, United States
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
Diabetes Associates Medical Group
Orange, California, 92868, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Encore Medical Research
Hollywood, Florida, 33021, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416, United States
SKY Clinical Research Network Group - Hall
Fayette, Mississippi, 39069, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203, United States
NYC Research
New York, New York, 10016, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Jefferson Clinical Research Institute (JCRI)
Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Rainier Clinical Research Center
Renton, Washington, 98057, 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
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB, Argentina
Stat Research S.A.
Ciudad Autónoma de Buenos Aire, Buenos Air, C1023AAB, Argentina
Centro Médico Viamonte
Buenos Aires, Ciudad Aut, C1120AAC, Argentina
Mautalen Salud e Investigación
Buenos Aires, Ciudad Aut, C1128AAF, Argentina
Instituto Centenario
CABA, Ciudad Autónoma de Buenos Aire, 1204, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, X5008HHW, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Mendoza Province, M5501ARP, Argentina
Instituto Médico Catamarca IMEC
Rosario, Santa Fe Province, 2000, Argentina
CEMEDIC
Buenos Aires, 1407, Argentina
CENUDIAB
Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina
Centro Diabetológico Dr. Waitman
Córdoba, 5000, Argentina
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, Zala County, 8800, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, Zala County, 8900, Hungary
Szent Margit Rendelointézet
Budapest, 1032, Hungary
Szent János Kórház
Budapest, 1125, Hungary
Strazsahegy Medicina Bt.
Budapest, H1171, Hungary
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, 261-0004, Japan
Yuri Ono Clinic
Sapporo, Hokkaido, 060-0001, Japan
Nakamoto Internal Medicine Clinic
Mito, Ibaraki, 310-0826, Japan
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, 310-0845, Japan
Noritake Clinic
Ushiku, Ibaraki, 300-1207, Japan
Matoba Internal Medicine Clinic
Ebina, Kanagawa, 243-0432, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, 242-0004, Japan
Shiraiwa Medical Clinic
Kashihara, Osaka, 582-0005, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1045, Japan
Shimizu Clinic Fusa
Saitama-shi, Saitama, 336-0967, Japan
Oyama East Clinic
Oyama, Tochigi, 323-0022, Japan
Tokyo-Eki Center-building Clinic
Chuo Ku, Tokyo, 103-0027, Japan
The Institute of Medical Science, Asahi Life Foundation
Chuo-ku, Tokyo, 103-0002, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Jinnouchi Hospital
Kumamoto, 862-0976, Japan
Heiwadai Hospital
Miyazaki, 880-0034, Japan
AMC Nishiumeda Clinic
Osaka, 530-0001, Japan
Abe Clinic
Ōita, 870-0039, Japan
OMEDICA Medical Center
Poznan, Greater Poland Voivodeship, 60-111, Poland
Gaja Poradnie Lekarskie Maciej Wiza
Poznan, Greater Poland Voivodeship, 61-251, Poland
NZOZ Diab-Endo-Met
Krakow, Lesser Poland Voivodeship, 31-261, Poland
Private Practice - Dr. Robert Witek
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
CenterMed Lublin NZOZ
Lublin, Lublin Voivodeship, 20-044, Poland
Gabinety TERPA
Lublin, Lublin Voivodeship, 20-333, Poland
NZOZ Medica
Lublin, Lublin Voivodeship, 20-538, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Śląska, Silesian Voivodeship, 41-709, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, 90338, Poland
IRMED
Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917, Puerto Rico
Mgcendo Llc
San Juan, 00921, Puerto Rico
MediVet s.r.o.
Malacky, Bratislava Region, 901 01, Slovakia
Human Care s.r.o.
Košice, Košice Region, 04012, Slovakia
Areteus s.r.o.
Trebišov, Košice Region, 075 01, Slovakia
MEDI-DIA s.r.o.
Sabinov, Presov, 083 01, Slovakia
Diacrin .s.ro.
Bratislava, 84102, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, 020 01, Slovakia
ENDIAMED s.r.o
Dolný Kubín, Žilina Region, 026 01, Slovakia
Kangwon National University Hospital
Chuncheon, Kang-won-do, 24289, South Korea
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426, South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, 15355, South Korea
Hanyang University Guri Hospital
Guri-si, Kyǒnggi-do, 11923, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, Kyǒngsangbuk-do, 42415, South Korea
Inje University Sanggye Paik Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 01757, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 07441, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [Seoul], 134-090, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teuk, 03722, South Korea
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006, Spain
Centro Periférico de Especialidades Bola Azul
Almería, Almería, 04009, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, 41010, Spain
Clínica Juaneda
Palma de Mallorca, Balears [Baleares], 07014, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Vithas Hospital Sevilla
Seville, Sevilla, 41950, Spain
Hospital Universitario de La Ribera
Alzira, Valenciana, Comunitat, 46600, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, 46014, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Chung Shan Medical University Hospital
Taichung, Taichung, 402, Taiwan
Taichung Veterans General Hospital
Taichung, Taichung, 407, Taiwan
Chi Mei Medical Center
Tainan, Tainan, 71004, Taiwan
Fu Jen Catholic University Hospital
New Taipei City, 24352, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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: 41591636DERIVEDPhilis-Tsimikas A, Bergenstal RM, Bailey TS, Jinnouchi H, Thrasher JR, Ilag L, Mitra J, Syring K, Threlkeld RJ. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2279-2289. doi: 10.1016/S0140-6736(25)01044-X. Epub 2025 Jun 22.
PMID: 40562047DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2022
First Posted
March 11, 2022
Study Start
March 8, 2022
Primary Completion
May 15, 2024
Study Completion
May 15, 2024
Last Updated
June 3, 2025
Results First Posted
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the 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.