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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
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

Full criteria on ClinicalTrials.gov

Sites (113)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Cline Research Center
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CuritibaBrazilUnknown status
Hospital São Lucas de Copacabana
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Rio de JaneiroBrazilUnknown status
CPQuali Pesquisa Clínica
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São PauloBrazilUnknown status
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilUnknown status
CPCLIN
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São PauloBrazilUnknown status
CEDOES
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VitóriaBrazilUnknown status
LMC Diabetes & Endocrinology
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BramptonCanadaUnknown status
Aggarwal and Associates Limited
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BramptonCanadaUnknown status
9109-0126 Quebec Inc.
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MontrealCanadaUnknown status
LMC Manna Research
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OttawaCanadaUnknown status
Bluewater Clinical Research Group Inc.
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SarniaCanadaUnknown status
Centricity Research Etobicoke Endocrinology
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TorontoCanadaUnknown status
Fadia El Boreky Medicine
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WaterlooCanadaUnknown status
Beijing Pinggu District Hospital
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BeijingChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Changzhou No.2 People's Hospital
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ChangzhouChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chengdu Fifth People's Hospital
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ChengduChinaUnknown status
Chongqing General Hospital
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ChongqingChinaUnknown status
Zhejiang Hospital
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HangzhouChinaUnknown status
The Fourth Hospital of Harbin Medical University
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HarbinChinaUnknown status
The First Hospital of Harbin Medical University
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HarbinChinaUnknown status
Hebei Medical University - Harrison International Peace Hospital
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Hengshui ShiChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The First Affiliated Hospital of Henan University of Science &Technology
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Luoyang ShiChinaUnknown status
The Third Hospital of Nanchang
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NanchangChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Nanjing First Hospital
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NanjingChinaUnknown status
Nanjing Medical University - Nanjing Jiangning Hospital
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NanjingChinaUnknown status
Ningbo First Hospital
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NingboChinaUnknown status
Shanghai Putuo District Center Hospital
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ShanghaiChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tianjin Medical University Zhu Xianyi Memorial Hospital
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TianjinChinaUnknown status
The Affiliated Jiangyin Hospital of Southeast University Medical College
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WuxiChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The First People's Hospital of Yueyang
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YueyangChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
Diacentrum Brandys n.L. s.r.o.
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Brandýs nad LabemCzechiaUnknown status
MUDr. Alena Vachova
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České BudějoviceCzechiaUnknown status
INTENDIA klinika s.r.o.
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Chrudim IIICzechiaUnknown status
MUDr. Tomas Edelsberger
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KrnovCzechiaUnknown status
MUDr. Tomas Hrdina
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OpočnoCzechiaUnknown status
Diahelp s.r.o
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Pardubice VCzechiaUnknown status
Milan Kvapil s.r.o., Diabetologicka ambulance
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PragueCzechiaUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden
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DresdenGermanyUnknown status
Medizentrum Essen Borbeck
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EssenGermanyUnknown status
InnoDiab Forschung Gmbh
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EssenGermanyUnknown status
Diabeteszentrum Hamburg West
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HamburgGermanyUnknown status
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
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Ludwigshafen am RheinGermanyUnknown status
RED-Institut GmbH
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Oldenburg in HolsteinGermanyUnknown status
Zentrum für klinische Studien
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Saint IngbertGermanyUnknown status
Praxis Sauter & Sauter & Vorbach
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WangenGermanyUnknown status
Alexandra Hospital
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AthensGreeceUnknown status
Athens Euroclinic
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AthensGreeceUnknown status
Iatriko Paleou Falirou Medical Center
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Palaió FáliroGreeceUnknown status
Thermi Clinic
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ThessalonikiGreeceUnknown status
Kumanomae Nishimura Clinic
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Arakawa-kuJapanUnknown status
Hayashi Diabetes Internal Medicine Clinic
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ChigasakiJapanUnknown status
Hasegawa Medical Clinic
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ChitoseJapanUnknown status
Fukuwa Clinic
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Chuo-kuJapanUnknown status
Nippon Kokan Fukuyama Hospital
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Fukuyama-shiJapanUnknown status
Hachioji Diabetes Clinic
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Hachioji-shiJapanUnknown status
Kashiwa City Hospital
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KashiwaJapanUnknown status
Yoshimura Clinic
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KumamotoJapanUnknown status
Tokuyama Clinic
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Mihama-ku,Chiba CityJapanUnknown status
MinamiAkatsukaClinic
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MitoJapanUnknown status
Tosaki Clinic for Diabetes and Endocrinology
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NagoyaJapanUnknown status
Nakakinen clinic
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NakaJapanUnknown status
Abe Clinic
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ŌitaJapanUnknown status
Medical Corporation Sato Medical clinic
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OotakuJapanUnknown status
Shimizu Clinic Fusa
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Saitama-shiJapanUnknown status
Manda Memorial Hospital
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SapporoJapanUnknown status
Tomonaga Clinic
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ShinjukuJapanUnknown status
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
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Yamato-shiJapanUnknown status
Kangwon National University Hospital
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ChuncheonSouth KoreaUnknown status
Hanyang University Guri Hospital
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Guri-siSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Investigacion En Salud Y Metabolismo Sc
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Chihuahua CityMexicoUnknown status
Centro de Endocrinologia y Nutricion
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CaguasPuerto RicoUnknown status
Private Practice - Dr. Paola Mansilla-Letelier
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GuaynaboPuerto RicoUnknown status
Qualmedica Research
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Bowling GreenUnited StatesUnknown status
New England Research Associates, LLC
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BridgeportUnited StatesUnknown status
East Coast Institute for Research - Canton
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CantonUnited StatesUnknown status
Dallas Diabetes Research Center
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DallasUnited StatesUnknown status
Clarity Clinical Research
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East SyracuseUnited StatesUnknown status
Neighborhood Healthcare Institute of Health
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EscondidoUnited StatesUnknown status
Qualmedica Research, LLC
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EvansvilleUnited StatesUnknown status
Valley Research
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FresnoUnited StatesUnknown status
New West Physicians Clinical Research
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GoldenUnited StatesUnknown status
NorCal Medical Research, Inc
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GreenbraeUnited StatesUnknown status
Tribe Clinical Research LLC
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GreenvilleUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
MedStar Health Research Institute (MedStar Physician Based Research Network)
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HyattsvilleUnited StatesUnknown status
East Coast Institute for Research, LLC
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JacksonvilleUnited StatesUnknown status
Southern Endocrinology Associates
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MesquiteUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
Catalina Research Institute, LLC
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MontclairUnited StatesUnknown status
Lucas Research, Inc.
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Morehead CityUnited StatesUnknown status
Intend Research, LLC
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NormanUnited StatesUnknown status
North Hills Family Medicine/North Hills Medical Research
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North Richland HillsUnited StatesUnknown status
Jefferson Clinical Research Institute (JCRI)
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PhiladelphiaUnited StatesUnknown status
SKY Clinical Research Network Group-Quinn
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RidgelandUnited StatesUnknown status
Endocrine and Metabolic Consultants
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RockvilleUnited StatesUnknown status
Southern California Dermatology, Inc.
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Santa AnaUnited StatesUnknown status
MultiCare Institute for Research and Innovation
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SpokaneUnited StatesUnknown status
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
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SpringfieldUnited StatesUnknown status
Clinvest Research, LLC
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SpringfieldUnited StatesUnknown status
Rophe Adult and Pediatric Medicine/SKYCRNG
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Union CityUnited StatesUnknown status
Iowa Diabetes and Endocrinology Research Center
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West Des MoinesUnited StatesUnknown status
Great Lakes Medical Research, LLC
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WestfieldUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.