NCT05275400CompletedPhase 3
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)
Source: ClinicalTrials.gov · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 986 (actual)
- First submitted
- 3 Mar 2022
- Start date
- 8 Mar 2022
- Primary completion date
- 15 May 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05275400
- EudraCT number
- 2021-002569-16
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 986
- From 8 Mar 2022 to the primary completion date, 15 May 2024
- 127 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Other illness
- 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)
- Have active or untreated malignancy
- 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
- coronary bypass surgery
Lab values
- Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
Other
- Are pregnant
- Have a significant weight gain or loss the past 3 months
Who the study is looking for
- 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
- Participants must be willing to stay on stable dose throughout the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (127)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CEMEDIC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Médico Viamonte Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Centenario Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro Medico Privado CEMAIC Coordinator of this site? Confirm its status | Capital | Argentina | Unknown status |
| Consultorio de Investigación Clínica EMO SRL Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aire | Argentina | Unknown status |
| CENUDIAB Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aire | Argentina | Unknown status |
| Stat Research S.A. Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aire | Argentina | Unknown status |
| Centro Diabetológico Dr. Waitman Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Coordinator of this site? Confirm its status | Godoy Cruz | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Instituto Médico Catamarca IMEC Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Go Centro Medico San Nicolas Coordinator of this site? Confirm its status | San Nicolás de los Arroyos | Argentina | Unknown status |
| CHUAC-Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Centro Periférico de Especialidades Bola Azul Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| Hospital Universitario de La Ribera Coordinator of this site? Confirm its status | Alzira | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Clínica Juaneda Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Quiron Infanta Luisa Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Vithas Hospital Sevilla Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| DRC Gyógyszervizsgáló Központ Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Unknown status |
| Szent János Kórház Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Szent Margit Rendelointézet Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Strazsahegy Medicina Bt. Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Kanizsai Dorottya Korhaz Coordinator of this site? Confirm its status | Nagykanizsa | Hungary | Unknown status |
| Zala Megyei Szent Rafael Korhaz Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| The Institute of Medical Science, Asahi Life Foundation Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Medical Corporation Chiseikai Tokyo Center Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Matoba Internal Medicine Clinic Coordinator of this site? Confirm its status | Ebina | Japan | Unknown status |
| Takai Internal Medicine Clinic Coordinator of this site? Confirm its status | Kamakura-shi | Japan | Unknown status |
| Shiraiwa Medical Clinic Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Jinnouchi Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Tokuyama Clinic Coordinator of this site? Confirm its status | Mihama-ku,Chiba City | Japan | Unknown status |
| Nakamoto Internal Medicine Clinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Kozawa Eye Hospital and Diabetes Center Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Heiwadai Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Abe Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| AMC Nishiumeda Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Oyama East Clinic Coordinator of this site? Confirm its status | Oyama | Japan | Unknown status |
| Shimizu Clinic Fusa Coordinator of this site? Confirm its status | Saitama-shi | Japan | Unknown status |
| Yuri Ono Clinic Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Takatsuki Red Cross Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Noritake Clinic Coordinator of this site? Confirm its status | Ushiku | Japan | Unknown status |
| Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Coordinator of this site? Confirm its status | Yamato-shi | Japan | Unknown status |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Unknown status |
| Kangwon National University Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
| Hanyang University Guri Hospital Coordinator of this site? Confirm its status | Guri-si | South Korea | Unknown status |
| Yeungnam Univeristy Medical Center Coordinator of this site? Confirm its status | Gyeongsan-si | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Inje University Sanggye Paik Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hallym University Kangnam Sacred Heart Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| NZOZ Diab-Endo-Met Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna Coordinator of this site? Confirm its status | Lódz | Poland | Unknown status |
| NZOZ Medica Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| CenterMed Lublin NZOZ Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Gabinety TERPA Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| IRMED Coordinator of this site? Confirm its status | Piotrkow Trybunalski | Poland | Unknown status |
| Gaja Poradnie Lekarskie Maciej Wiza Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| OMEDICA Medical Center Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki Coordinator of this site? Confirm its status | Ruda Śląska | Poland | Unknown status |
| Private Practice - Dr. Robert Witek Coordinator of this site? Confirm its status | Tarnów | Poland | Unknown status |
| GCM Medical Group, PSC - Hato Rey Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Mgcendo Llc Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Diacrin .s.ro. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| ENDIAMED s.r.o Coordinator of this site? Confirm its status | Dolný Kubín | Slovakia | Unknown status |
| HUMAN-CARE, s.r.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Unknown status |
| MediVet s.r.o. Coordinator of this site? Confirm its status | Malacky | Slovakia | Unknown status |
| DIA-MED CENTRUM s.r.o. Coordinator of this site? Confirm its status | Púchov | Slovakia | Unknown status |
| MEDI-DIA s.r.o. Coordinator of this site? Confirm its status | Sabinov | Slovakia | Unknown status |
| Areteus s.r.o. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Unknown status |
| Fu Jen Catholic University Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Chi Mei Medical Center Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Albany Medical College, Division of Community Endocrinology Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Gadolin Research Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Heritage Valley Medical Group, Inc. Coordinator of this site? Confirm its status | Beaver | United States | Unknown status |
| Aventiv Research Inc Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| John Muir Physician Network Research Center Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| Dallas Diabetes Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| AMCR Institute Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| Lillestol Research Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| SKY Clinical Research Network Group - Hall Coordinator of this site? Confirm its status | Fayette | United States | Unknown status |
| Encore Medical Research Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| National Research Institute - Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Unknown status |
| Rocky Mountain Clinical Research Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Scripps Whittier Diabetes Institute Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Palm Research Center Tenaya Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Balanced Life Health Care Solutions/SKYCRNG Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| Medical Investigations Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| L-MARC Research Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| HealthPartners Institute dba International Diabetes Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Suncoast Clinical Research, Inc. Coordinator of this site? Confirm its status | New Port Richey | United States | Unknown status |
| NYC Research Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Intend Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| West Orange Endocrinology Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Diabetes Associates Medical Group Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Jefferson Clinical Research Institute (JCRI) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Rainier Clinical Research Center Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Endocrine and Metabolic Consultants Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| University Clinical Investigators, Inc. Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Preferred Primary Care Physicians Coordinator of this site? Confirm its status | Uniontown | United States | Unknown status |
| Chase Medical Research, LLC Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
Related publications
- Hospitalization outcomes in adults with type 2 diabetes mellitus treated with once-weekly insulin efsitora versus once-daily basal insulins: A post hoc analysis of the QWINT-1 to -4 randomized trials.Diabetes Res Clin Pract · 2026 · PMID 42829184
- Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Using Basal Insulin: QWINT-3 Japan Subgroup Analysis.Diabetes Ther · 2026 · PMID 42565976
- 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 · PMID 41591636
This page is information, not medical advice. Discuss any trial with your doctor.