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
NCT ID: NCT05362058
Last Updated: 2025-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
928 participants
INTERVENTIONAL
2022-06-03
2024-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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500 U/mL - Insulin Efsitora Alfa
* Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period.
* Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.
Insulin Efsitora Alfa
Administered SC
100 U/mL - Insulin Degludec
* Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period.
* Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.
Insulin Degludec
Administered SC
Interventions
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Insulin Efsitora Alfa
Administered SC
Insulin Degludec
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion 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).
Exclusion Criteria
* 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 known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
* 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%.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Neighborhood Healthcare Institute of Health
Escondido, California, United States
Valley Research
Fresno, California, United States
NorCal Medical Research, Inc
Greenbrae, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
New West Physicians Clinical Research
Golden, Colorado, United States
New England Research Associates, LLC
Bridgeport, Connecticut, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
East Coast Institute for Research - Canton
Canton, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Qualmedica Research
Bowling Green, Kentucky, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi, United States
Clinvest Research LLC
Springfield, Missouri, United States
Clarity Clinical Research
East Syracuse, New York, United States
Great Lakes Medical Research, LLC
Westfield, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Lucas Research, Inc
Morehead City, North Carolina, United States
Intend Research, LLC
Norman, Oklahoma, United States
Jefferson Clinical Research Institute (JCRI)
Philadelphia, Pennsylvania, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Juno Research
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, United States
Multicare Institute for Research and Innovation
Spokane, Washington, United States
CEDOES
Vitória, Espírito Santo, Brazil
Cline Research Center
Curitiba, Paraná, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Hospital São Lucas de Copacabana
Rio de Janeiro, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
CPCLIN
São Paulo, , Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, , Brazil
LMC Diabetes & Endocrinology
Brampton, Ontario, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
LMC Manna Research
Ottawa, Ontario, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
Centricity Research Etobicoke Endocrinology
Toronto, Ontario, Canada
Fadia El Boreky Medicine
Waterloo, Ontario, Canada
9109-0126 Quebec Inc.
Montreal, Quebec, Canada
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Hebei Medical University - Harrison International Peace Hospital
Hengshui Shi, Hebei, China
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Yueyang
Yueyang, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Putuo District Center Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
INTENDIA klinika s.r.o.
Chrudim III, Chrudim, Czechia
MUDr. Alena Vachova
České Budějovice, Jihočeský kraj, Czechia
MUDr. Tomas Edelsberger
Krnov, Moravskoslezský kraj, Czechia
Diahelp s.r.o
Pardubice V, Pardubice, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, Praha 4, Czechia
Diacentrum Brandys n.L. s.r.o.
Brandýs nad Labem, Praha-vých, Czechia
MUDr. Tomas Hrdina
Opočno, Rychnov Nad Kněžnou, Czechia
Praxis Sauter & Sauter & Vorbach
Wangen, Baden-Wurttemberg, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, Germany
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, Germany
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Zentrum für klinische Studien
Saint Ingbert, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Iatriko Paleou Falirou Medical Center
Palaió Fáliro, Attikí (Region), Greece
Alexandra Hospital
Athens, Attikí, Greece
Thermi Clinic
Thessaloniki, Thessaloníki, Greece
Athens Euroclinic
Athens, , Greece
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, Japan
Kashiwa City Hospital
Kashiwa, Chiba, Japan
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, Japan
Nippon Kokan Fukuyama Hospital
Fukuyama-shi, Hiroshima, Japan
Hasegawa Medical Clinic
Chitose, Hokkaido, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, Japan
MinamiAkatsukaClinic
Mito, Ibaraki, Japan
Nakakinen clinic
Naka, Ibaraki, Japan
Hayashi Diabetes Internal Medicine Clinic
Chigasaki, Kanagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, Japan
Shimizu Clinic Fusa
Saitama-shi, Saitama, Japan
Kumanomae Nishimura Clinic
Arakawa-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Hachioji Diabetes Clinic
Hachioji-shi, Tokyo, Japan
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, Japan
Tomonaga Clinic
Shinjuku, Tokyo, Japan
Yoshimura Clinic
Kumamoto, , Japan
Abe Clinic
Ōita, , Japan
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, , Mexico
Centro de Endocrinologia y Nutricion
Caguas, , Puerto Rico
Private Practice - Dr. Paola Mansilla-Letelier
Guaynabo, , Puerto Rico
Kangwon National University Hospital
Chuncheon, Kang-won-do, South Korea
Hanyang University Guri Hospital
Guri-si, Kyǒnggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teuk, South Korea
Countries
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References
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Wysham C, Bajaj HS, Del Prato S, Franco DR, Kiyosue A, Dahl D, Zhou C, Carr MC, Case M, Firmino Goncalves L; QWINT-2 Investigators. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2024 Dec 12;391(23):2201-2211. doi: 10.1056/NEJMoa2403953. Epub 2024 Sep 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)
Other Identifiers
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I8H-MC-BDCX
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005891-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18262
Identifier Type: -
Identifier Source: org_study_id
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