NCT05362058CompletedPhase 3
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 16 May 2025
Brief summary (registry, in English)
The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 928 (actual)
- First submitted
- 2 May 2022
- Start date
- 3 Jun 2022
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05362058
- EudraCT number
- 2021-005891-21
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 928
- From 3 Jun 2022 to the primary completion date, 10 Apr 2024
- 113 sites in 11 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 a history of greater than (\>) 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 a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
- 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, greater than or equal to (≥) 5%.
Other illness
- Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
Lab values
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
Who the study is looking for
- Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
- Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
- Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
- These antihyperglycemic medications are accepted in the study
- dipeptidyl peptidase-4 (DPP-4) inhibitors
- sodium-glucose cotransporter 2 (SGLT2) inhibitors
- biguanides, such as metformin
- alpha-glucosidase inhibitors
- glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
- Sulfonylureas, or
- Thiazolidinediones.
- Are insulin naïve.
- Exceptions:
- short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
- Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (113)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Cline Research Center Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital São Lucas de Copacabana Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| LMC Diabetes & Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Aggarwal and Associates Limited Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| 9109-0126 Quebec Inc. Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| LMC Manna Research Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Unknown status |
| Centricity Research Etobicoke Endocrinology Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Fadia El Boreky Medicine Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Beijing Pinggu District Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Changzhou No.2 People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chengdu Fifth People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Zhejiang Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Fourth Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Hebei Medical University - Harrison International Peace Hospital Coordinator of this site? Confirm its status | Hengshui Shi | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang Shi | China | Unknown status |
| The Third Hospital of Nanchang Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanjing Medical University - Nanjing Jiangning Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Shanghai Putuo District Center Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Zhu Xianyi Memorial Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Affiliated Jiangyin Hospital of Southeast University Medical College Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| The First People's Hospital of Yueyang Coordinator of this site? Confirm its status | Yueyang | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Diacentrum Brandys n.L. s.r.o. Coordinator of this site? Confirm its status | Brandýs nad Labem | Czechia | Unknown status |
| MUDr. Alena Vachova Coordinator of this site? Confirm its status | České Budějovice | Czechia | Unknown status |
| INTENDIA klinika s.r.o. Coordinator of this site? Confirm its status | Chrudim III | Czechia | Unknown status |
| MUDr. Tomas Edelsberger Coordinator of this site? Confirm its status | Krnov | Czechia | Unknown status |
| MUDr. Tomas Hrdina Coordinator of this site? Confirm its status | Opočno | Czechia | Unknown status |
| Diahelp s.r.o Coordinator of this site? Confirm its status | Pardubice V | Czechia | Unknown status |
| Milan Kvapil s.r.o., Diabetologicka ambulance Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Universitaetsklinikum Carl Gustav Carus Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Medizentrum Essen Borbeck Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Diabeteszentrum Hamburg West Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Unknown status |
| RED-Institut GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Unknown status |
| Zentrum für klinische Studien Coordinator of this site? Confirm its status | Saint Ingbert | Germany | Unknown status |
| Praxis Sauter & Sauter & Vorbach Coordinator of this site? Confirm its status | Wangen | Germany | Unknown status |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Athens Euroclinic Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Iatriko Paleou Falirou Medical Center Coordinator of this site? Confirm its status | Palaió Fáliro | Greece | Unknown status |
| Thermi Clinic Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Kumanomae Nishimura Clinic Coordinator of this site? Confirm its status | Arakawa-ku | Japan | Unknown status |
| Hayashi Diabetes Internal Medicine Clinic Coordinator of this site? Confirm its status | Chigasaki | Japan | Unknown status |
| Hasegawa Medical Clinic Coordinator of this site? Confirm its status | Chitose | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Nippon Kokan Fukuyama Hospital Coordinator of this site? Confirm its status | Fukuyama-shi | Japan | Unknown status |
| Hachioji Diabetes Clinic Coordinator of this site? Confirm its status | Hachioji-shi | Japan | Unknown status |
| Kashiwa City Hospital Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Yoshimura Clinic 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 |
| MinamiAkatsukaClinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Tosaki Clinic for Diabetes and Endocrinology Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Nakakinen clinic Coordinator of this site? Confirm its status | Naka | Japan | Unknown status |
| Abe Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Medical Corporation Sato Medical clinic Coordinator of this site? Confirm its status | Ootaku | Japan | Unknown status |
| Shimizu Clinic Fusa Coordinator of this site? Confirm its status | Saitama-shi | Japan | Unknown status |
| Manda Memorial Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tomonaga Clinic Coordinator of this site? Confirm its status | Shinjuku | Japan | Unknown status |
| Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Coordinator of this site? Confirm its status | Yamato-shi | Japan | 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 |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigacion En Salud Y Metabolismo Sc Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Centro de Endocrinologia y Nutricion Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| Private Practice - Dr. Paola Mansilla-Letelier Coordinator of this site? Confirm its status | Guaynabo | Puerto Rico | Unknown status |
| Qualmedica Research Coordinator of this site? Confirm its status | Bowling Green | United States | Unknown status |
| New England Research Associates, LLC Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| East Coast Institute for Research - Canton Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Dallas Diabetes Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Clarity Clinical Research Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| Neighborhood Healthcare Institute of Health Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| Qualmedica Research, LLC Coordinator of this site? Confirm its status | Evansville | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| New West Physicians Clinical Research Coordinator of this site? Confirm its status | Golden | United States | Unknown status |
| NorCal Medical Research, Inc Coordinator of this site? Confirm its status | Greenbrae | United States | Unknown status |
| Tribe Clinical Research LLC Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MedStar Health Research Institute (MedStar Physician Based Research Network) Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
| East Coast Institute for Research, LLC Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Catalina Research Institute, LLC Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Intend Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| North Hills Family Medicine/North Hills Medical Research Coordinator of this site? Confirm its status | North Richland Hills | United States | Unknown status |
| Jefferson Clinical Research Institute (JCRI) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| SKY Clinical Research Network Group-Quinn Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| Endocrine and Metabolic Consultants Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Southern California Dermatology, Inc. Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| MultiCare Institute for Research and Innovation Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Great Lakes Medical Research, LLC Coordinator of this site? Confirm its status | Westfield | United States | Unknown status |
Related publications
- Efficacy and Safety of Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Who Are Insulin-Naïve: Japan Subgroup Analysis of QWINT-2.Diabetes Ther · 2026 · PMID 42177728
- 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.