NCT05463744CompletedPhase 3
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Source: ClinicalTrials.gov · Last updated 24 Jun 2025
Brief summary (registry, in English)
The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 692 (actual)
- First submitted
- 15 Jul 2022
- Start date
- 12 Aug 2022
- Primary completion date
- 7 May 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 1 diabetes
- NCT number
- NCT05463744
- EudraCT number
- 2021-005892-38
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 692
- From 12 Aug 2022 to the primary completion date, 7 May 2024
- 83 sites in 7 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 more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
- Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.
Other illness
- Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
Who the study is looking for
- Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
- Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
- Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
- Have a body mass index of ≤35 kilogram/square meter (kg/m²)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (83)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigaciones Medicas Imoba Srl Coordinator of this site? Confirm its status | Balvanera | Argentina | Unknown status |
| Instituto Médico Especializado (IME) 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 |
| CEDIC 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 |
| Centro Medico Privado San Vicente Diabetes Coordinator of this site? Confirm its status | Córdoba | 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 |
| CIAD Moron Coordinator of this site? Confirm its status | Morón | Argentina | Unknown status |
| Centro Medico Privado de Reumatologia Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Centro de Salud e Investigaciones Médicas Coordinator of this site? Confirm its status | Santa Rosa | Argentina | Unknown status |
| The Institute for Adult Disease, Asahi Life Foundation Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Clinic Masae Minami Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hachioji Diabetes Clinic Coordinator of this site? Confirm its status | Hachioji-shi | Japan | Unknown status |
| Takai Internal Medicine Clinic Coordinator of this site? Confirm its status | Kamakura-shi | Japan | Unknown status |
| Jinnouchi Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| MinamiAkatsukaClinic Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Heiwadai Hospital Coordinator of this site? Confirm its status | Miyazaki | 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 |
| 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 |
| 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 |
| NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| SN ZOZ Lege Artis Poradnia Diabetologiczna Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Gabinety TERPA Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| NZOZ Medica Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Centrum Medyczne "Diabetika" Coordinator of this site? Confirm its status | Radom | Poland | Unknown status |
| Centralny Szpital Kliniczny MSWiA w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Nbr Polska Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Private Practice - Dr. Janusz Gumprecht Coordinator of this site? Confirm its status | Zabrze | Poland | Unknown status |
| Advanced Clinical Research, LLC Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| Endocrinologist Metabolic Clinic & Research Institute Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| ENDIAMED s.r.o Coordinator of this site? Confirm its status | Dolný Kubín | Slovakia | Unknown status |
| Funkystuff Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Unknown status |
| Tatratrial s.r.o. Coordinator of this site? Confirm its status | Rožňava | Slovakia | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | 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 |
| Chi Mei Medical Center Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei City | Taiwan | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Research Foundation of SUNY - University of Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| John Muir Physician Network Research Center Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| North Texas Endocrine Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Dallas Diabetes Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Research Institute Of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Northeast Research Institute (NERI) Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
| Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| East-West Medical Research Institute Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Amir A Hassan, MD, PA Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Biopharma Informatic, LLC 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 |
| Rocky Mountain Clinical Research Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Palm Research Center Sunset Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Palm Research Center Tenaya Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| East Coast Institute for Research at The Jones Center Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Catalina Research Institute, LLC Coordinator of this site? Confirm its status | Montclair | 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 |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Hanson Clinical Research Center Coordinator of this site? Confirm its status | Port Charlotte | 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 |
| Sansum Diabetes Research Institute Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Cotton O'Neil Clinical Research Center Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| University Clinical Investigators, Inc. Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.