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

Last updated: May 5, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Macular Edema

Diabetic Vitreous Hemorrhage

Treatment

Insulin Degludec

Insulin Efsitora Alfa

Clinical Study ID

NCT05362058
18262
2021-005891-21
I8H-MC-BDCX
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have diagnosis of Type 2 diabetes (T2D) according to the World Health OrganizationCriteria

  • 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 3months prior to screening and willing to continue the stable treatment for theduration 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 priorinsulin treatment for gestational diabetes

  • Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).

Exclusion

Exclusion Criteria:

  • Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specifictype of diabetes other than T2D, for example, monogenic diabetes, diseases of theexocrine pancreas, or drug-induced or chemical-induced diabetes.

  • Have a history of greater than (>) 1 episode of ketoacidosis or hyperosmolar stateor coma requiring hospitalization within 6 months prior to screening. Have hadsevere hypoglycemia episodes within 6 months prior to screening. Have a history ofrenal transplantation, are currently receiving renal dialysis, or have an estimatedglomerular filtration rate.

  • Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any othertraits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.

  • Have had New York Heart Association Class IV heart failure or any of thesecardiovascular 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, forexample 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%.

Study Design

Total Participants: 928
Treatment Group(s): 2
Primary Treatment: Insulin Degludec
Phase: 3
Study Start date:
June 03, 2022
Estimated Completion Date:
April 10, 2024

Connect with a study center

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Cline Research Center

    Curitiba, Paraná 80030-480
    Brazil

    Site Not Available

  • CPCLIN

    Natal, Rio Grande Do Norte 01228-200
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13034-685
    Brazil

    Site Not Available

  • Hospital São Lucas Copacabana

    Rio de Janeiro, 22061-080
    Brazil

    Site Not Available

  • Hospital São Lucas de Copacabana

    Rio de Janeiro, 22061-080
    Brazil

    Site Not Available

  • CPCLIN

    Sao Paulo, 01228-200
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Hospital das Clinicas FMUSP

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • LMC Clinical Research Inc. (Calgary)

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • LMC Diabetes & Endocrinology

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • LMC Clinical Research Inc. (Brampton)

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • LMC Diabetes & Endocrinology

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • LMC Clinical Research Inc. (Oakville)

    Oakville, Ontario L6M 1M1
    Canada

    Site Not Available

  • LMC Clinical Research Inc. (Ottawa)

    Ottawa, Ontario K2J 0V2
    Canada

    Site Not Available

  • LMC Manna Research

    Ottawa, Ontario K2J 0V2
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Centricity Research Etobicoke Endocrinology

    Toronto, Ontario M9R 4E1
    Canada

    Site Not Available

  • LMC Etobicoke

    Toronto, Ontario M9R 4E1
    Canada

    Site Not Available

  • Fadia El Boreky Medicine

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • 9109-0126 Quebec Inc.

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100005
    China

    Site Not Available

  • Beijing Pinggu District Hospital

    Beijing, Beijing 101200
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Changping, Beijing 102202
    China

    Site Not Available

  • Chongqing General Hospital

    Chongqing, Chongqing 400014
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Cangzhou People's Hospital Medical College

    Cangzhou, Hebei 061600
    China

    Site Not Available

  • Hebei Medical University - Harrison International Peace Hospital

    Hengshui Shi, Hebei 053000
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The First Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan 471003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The First People's Hospital of Yueyang

    Yueyang, Hunan 414000
    China

    Site Not Available

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu 213164
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Site Not Available

  • Nanjing Medical University - Nanjing Jiangning Hospital

    Nanjing, Jiangsu 211100
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing Shi, Jiangsu 210012
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • The Affiliated Jiangyin Hospital of Southeast University Medical College

    Wuxi Shi, Jiangsu 214400
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi 330009
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Shanghai 9th People hospital

    Shanghai, Shanghai 200023
    China

    Site Not Available

  • Shanghai Putuo District Center Hospital

    Shanghai, Shanghai 200062
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Cheng Du, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Cheng Du, Sichuan 610041
    China

    Site Not Available

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan 611130
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Tianjin Medical University Zhu Xianyi Memorial Hospital

    Tianjin, Tianjin 300070
    China

    Site Not Available

  • Zhejiang Hospital

    Hangzhou, Zhejiang 310013
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo, Zhejiang 315010
    China

    Site Not Available

  • INTENDIA klinika s.r.o.

    Chrudim III, Chrudim 537 01
    Czechia

    Site Not Available

  • MUDr. Alena Vachova

    Ceske Budejovice, Jihočeský 37011
    Czechia

    Site Not Available

  • MUDr. Tomas Edelsberger

    Krnov, Moravskoslezský Kraj 79401
    Czechia

    Site Not Available

  • Diahelp s.r.o

    Pardubice V, Pardubice 530 02
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Praha, Praha 4 14900
    Czechia

    Site Not Available

  • Diacentrum Brandys n.L. s.r.o.

    Brandys nad Labem, Praha-vých 25001
    Czechia

    Site Not Available

  • MUDr. Tomas Hrdina

    Opocno, Rychnov Nad Kněžnou 517 73
    Czechia

    Site Not Available

  • INTENDIA klinika s.r.o.

    Chrudim, 537 01
    Czechia

    Site Not Available

  • Diahelp s.r.o

    Pardubice, 530 02
    Czechia

    Site Not Available

  • Praxis Sauter & Sauter & Vorbach

    Wangen im Allgäu, Baden-Württemberg 88239
    Germany

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Medizentrum Essen Borbeck

    Essen, Nordrhein-Westfalen 45355
    Germany

    Site Not Available

  • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

    Ludwigshafen am Rhein, Rheinland-Pfalz 67059
    Germany

    Site Not Available

  • Zentrum für klinische Studien

    Saint Ingbert, Saarland 66386
    Germany

    Site Not Available

  • Zentrum für klinische Studien

    Sankt Ingbert, Saarland 66386
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, Schleswig-Holstein 23758
    Germany

    Site Not Available

  • Diabeteszentrum Hamburg West

    Hamburg, 22607
    Germany

    Site Not Available

  • Praxis Sauter & Sauter & Vorbach

    Wangen, 88239
    Germany

    Site Not Available

  • Alexandra General Hospital of Athens

    Athens, Attikí 11528
    Greece

    Site Not Available

  • Alexandra Hospital

    Athens, Attikí 11528
    Greece

    Site Not Available

  • Iatriko Paleou Falirou Medical Center

    Palaió Fáliro, Attikí (Region) 17562
    Greece

    Site Not Available

  • Iatriko Paleou Falirou Medical Center

    Paleo Faliro, Attikí (Region) 17562
    Greece

    Site Not Available

  • Thermi Clinic

    Thermi,Thessaloniki, Thessaloníki 570 01
    Greece

    Site Not Available

  • Thermi Clinic

    Thessaloniki, Thessaloníki 570 01
    Greece

    Site Not Available

  • Athens Euroclinic

    Athens, 115 21
    Greece

    Site Not Available

  • Tosaki Clinic for Diabetes and Endocrinology

    Nagoya, Aichi 468-0009
    Japan

    Site Not Available

  • Tosaki Clinic for Diabetes and Endocrinology

    Nagoya-shi, Aichi 468-0009
    Japan

    Site Not Available

  • Kashiwa City Hospital

    Kashiwa, Chiba 277-0825
    Japan

    Site Not Available

  • Tokuyama Clinic

    Mihama-ku,Chiba City, Chiba 261-0004
    Japan

    Site Not Available

  • Nippon Kokan Fukuyama Hospital

    Fukuyama-shi, Hiroshima 721-0927
    Japan

    Site Not Available

  • Hasegawa Medical Clinic

    Chitose, Hokkaido 066-0032
    Japan

    Site Not Available

  • Manda Memorial Hospital

    Sapporo, Hokkaido 060-0062
    Japan

    Site Not Available

  • MinamiAkatsukaClinic

    Mito, Ibaraki 311-4153
    Japan

    Site Not Available

  • Nakakinen clinic

    Naka, Ibaraki 311-0113
    Japan

    Site Not Available

  • Hayashi Diabetes Internal Medicine Clinic

    Chigasaki, Kanagawa 253-0044
    Japan

    Site Not Available

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa 242-0004
    Japan

    Site Not Available

  • Shimizu Clinic Fusa

    Saitama-shi, Saitama 336-0967
    Japan

    Site Not Available

  • Oyama East Clinic

    Oyama, Tochigi 323-0022
    Japan

    Site Not Available

  • Kumanomae Nishimura Clinic

    Arakawa-ku, Tokyo 116-0012
    Japan

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo 103-0027
    Japan

    Site Not Available

  • Hachioji Diabetes Clinic

    Hachioji, Tokyo 192-0083
    Japan

    Site Not Available

  • Hachioji Diabetes Clinic

    Hachioji-shi, Tokyo 192-0083
    Japan

    Site Not Available

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo 143-0015
    Japan

    Site Not Available

  • Tomonaga Clinic

    Shinjuku, Tokyo 160-0022
    Japan

    Site Not Available

  • Medical Corporation Sato Medical clinic

    Ōtake, Tokyo 143-0015
    Japan

    Site Not Available

  • Tokuyama Clinic

    Chiba, 261-0004
    Japan

    Site Not Available

  • Jinnouchi Hospital

    Kumamoto, 862-0976
    Japan

    Site Not Available

  • Yoshimura Clinic

    Kumamoto, 861-8039
    Japan

    Site Not Available

  • Abe Clinic

    Oita, 870-0039
    Japan

    Site Not Available

  • Kangwon National University Hospital

    Chuncheon, Kang-won-do 24289
    Korea, Republic of

    Site Not Available

  • Kangwon National University Hospital

    Chuncheon-si, Kang-won-do 24289
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital

    Guri-si, Kyǒnggi-do 11923
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teuk 03722
    Korea, Republic of

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Centro de Endocrinologia y Nutricion

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Isis Clinical Research Center

    Guaynabo, 00970
    Puerto Rico

    Site Not Available

  • Private Practice - Dr. Paola Mansilla-Letelier

    Guaynabo, 00970
    Puerto Rico

    Site Not Available

  • Neighborhood Healthcare Institute of Health

    Escondido, California 92025
    United States

    Site Not Available

  • Valley Research

    Fresno, California 93720
    United States

    Site Not Available

  • NorCal Medical Research, Inc

    Greenbrae, California 94904
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • New West Physicians Clinical Research

    Golden, Colorado 80401
    United States

    Site Not Available

  • New England Research Associates, LLC

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • East Coast Institute for Research - Canton

    Canton, Georgia 30114
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

    Springfield, Illinois 62711
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Qualmedica Research

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • MedStar Health Research Institute (MedStar Physician Based Research Network)

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Endocrine and Metabolic Consultants

    Rockville, Maryland 20852
    United States

    Site Not Available

  • SKY Clinical Research Network Group-Quinn

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Clarity Clinical Research

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Westfield, New York 14787
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Jefferson Clinical Research Institute (JCRI)

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • North Hills Family Medicine/North Hills Medical Research

    North Richland Hills, Texas 76180
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Multicare Institute for Research and Innovation

    Spokane, Washington 99202
    United States

    Site Not Available

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