| Outcome Measures: |
Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for the treatment of type 2 diabetes (T2D) in adults., Baseline, Week 52 | Secondary: Change from Baseline in HbA1c, Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants using glucagon-like peptide-1 (GLP-1) receptor agonists, Baseline, Week 52|Change from Baseline in HbA1c, Change from Baseline in HbA1c of insulin efsitora alfa (LY3209590) compared to insulin degludec for participants not using GLP-1 receptor agonists, Baseline, Week 52|Time in Glucose Range, Time in glucose range between 70 and 180 milligram/deciliter inclusive, collected during the continued glucose monitoring session prior to week 52., Week 48 to Week 52|Change from Baseline in HbA1c, Baseline, Week 26|Time in Glucose Range, Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive, collected during the CGM session prior to week 26., Week 22 to Week 26|Change from Baseline in Fasting Glucose, Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG), Baseline, Week 26 and Baseline, Week 52|Glucose Variability, Glucose variability measured during the CGM session prior to week 26 and week 52., Week 22 to Week 26, and Week 48 to Week 52|Insulin Dose, Insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary., Week 26 and Week 52|Incidence and Rate of Composite Level 2 or Level 3 Hypoglycemia Events, The incidence and event rate of participant-reported clinically significant hypoglycemia events measured during treatment period., Baseline to Week 52|Incidence and Rate of Composite Level 2 or Level 3 Nocturnal Hypoglycemia Events, The incidence and event rate of participant-reported clinically significant nocturnal hypoglycemia (\<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase., Baseline to Week 52|Change from Baseline in Body Weight, Change from baseline in body weight, Baseline, Week 26 and Baseline, Week 52|Time in Hypoglycemia Range with Glucose <70 mg/dL (3.9 mmol/L), Time in hypoglycemia with glucose \<70 mg/dL (3.9 mmol/L) measurements collected during continuous glucose monitoring (CGM) prior to week 12, 26, and 52., Week 8 to Week 12, Week 22 to Week 26, Week 48 to Week 52|Time in Hypoglycemia Range with Glucose <54 mg/dL (3.0 mmol/L), Time in hypoglycemia with glucose \<54 mg/dL (3.0 mmol/L) measurements collected during (CGM) sessions collected prior to week 12, 26, and 52., Week 8 to Week 12, Week 22 to Week 26, Week 48 to Week 52|Time in Hyperglycemia Range with Glucose >180 mg/dL, Time in hypoglycemia with glucose \>180 mg/dL measurements collected during CGM sessions collected prior to week 12, 26, and 52., Week 8 to 12, Week 22 to Week 26, Week 48 to Week 52|Change from Baseline in Treatment-Related IMPACT Measures-Diabetes (TRIM-D), TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. Each of the 28 items is assessed on a 5-point scale, where higher scores indicate a better health state., Baseline, Week 26 and Baseline, Week 52|Change from Baseline in Short Form-36 Version 2 Health Survey Acute Form (SF-36), SF-36 v2 Health Survey Acute form is a participant self-administered measure designed to assess these 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each domain is scored individually. Scoring of each domain and both summary scores, physical and mental component scores, are norm based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10. Higher scores indicate better levels of function and/or better health., Baseline, Week 26 and Baseline, Week 52|Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L), EQ-5D-5L assesses 5 dimensions of health mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The 5L version scores each dimension at 5 levels, no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems. Each domain score ranges between less than 0 to 1, where negative values are valued as worse than dead, 0 is a health state equivalent to death, and 1 represents perfect health., Baseline, Week 26 and Baseline, Week 52
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| Locations: |
Neighborhood Healthcare Institute of Health, Escondido, California, 92025, United States|Valley Research, Fresno, California, 93720, United States|NorCal Medical Research, Inc, Greenbrae, California, 94904, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Southern California Dermatology, Inc., Santa Ana, California, 92701, United States|New West Physicians Clinical Research, Golden, Colorado, 80401, United States|New England Research Associates, LLC, Bridgeport, Connecticut, 06606, United States|East Coast Institute for Research, LLC, Jacksonville, Florida, 32204, United States|East Coast Institute for Research - Canton, Canton, Georgia, 30114, United States|Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, 30291, United States|Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative, Springfield, Illinois, 62711, United States|Qualmedica Research, LLC, Evansville, Indiana, 47715, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Qualmedica Research, Bowling Green, Kentucky, 42101, United States|MedStar Health Research Institute (MedStar Physician Based Research Network), Hyattsville, Maryland, 20782, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|SKY Clinical Research Network Group-Quinn, Ridgeland, Mississippi, 39157, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Clarity Clinical Research, East Syracuse, New York, 13057, United States|Great Lakes Medical Research, LLC, Westfield, New York, 14787, United States|Monroe Biomedical Research, Monroe, North Carolina, 28112, United States|Lucas Research, Inc, Morehead City, North Carolina, 28557, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Jefferson Clinical Research Institute (JCRI), Philadelphia, Pennsylvania, 19114, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Juno Research, Houston, Texas, 77040, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|North Hills Family Medicine/North Hills Medical Research, North Richland Hills, Texas, 76180, United States|Multicare Institute for Research and Innovation, Spokane, Washington, 99202, United States|CEDOES, Vitória, Espírito Santo, 29055450, Brazil|Cline Research Center, Curitiba, Paraná, 80030-480, Brazil|Centro de Pesquisa Sao Lucas, Campinas, São Paulo, 13034-685, Brazil|Hospital São Lucas de Copacabana, Rio de Janeiro, 22061-080, Brazil|CPCLIN, Sao Paulo, 01228-200, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|LMC Diabetes & Endocrinology, Brampton, Ontario, L6S 0C6, Canada|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|LMC Manna Research, Ottawa, Ontario, K2J 0V2, Canada|Bluewater Clinical Research Group Inc., Sarnia, Ontario, N7T 4X3, Canada|Centricity Research Etobicoke Endocrinology, Toronto, Ontario, M9R 4E1, Canada|Fadia El Boreky Medicine, Waterloo, Ontario, N2J 1C4, Canada|9109-0126 Quebec Inc., Montreal, Quebec, H4N 2W2, Canada|Beijing Pinggu District Hospital, Beijing, Beijing, 101200, China|Chongqing General Hospital, Chongqing, Chongqing, 400014, China|Hebei Medical University - Harrison International Peace Hospital, Hengshui Shi, Hebei, 053000, China|The First Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The Fourth Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The First Affiliated Hospital of Henan University of Science &Technology, Luoyang Shi, Henan, 471003, China|The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450014, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China|The First People's Hospital of Yueyang, Yueyang, Hunan, 414000, China|Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213164, China|Nanjing First Hospital, Nanjing Shi, Jiangsu, 210012, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Nanjing Medical University - Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211100, China|The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China|The Affiliated Jiangyin Hospital of Southeast University Medical College, Wuxi Shi, Jiangsu, 214400, China|Wuxi People's Hospital, Wuxi, Jiangsu, 214023, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212000, China|The Third Hospital of Nanchang, Nanchang, Jiangxi, 330009, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|Shanghai Putuo District Center Hospital, Shanghai, Shanghai, 200062, China|West China Hospital of Sichuan University, Cheng Du, Sichuan, 610041, China|Chengdu Fifth People's Hospital, Chengdu, Sichuan, 611130, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, 300052, China|Tianjin Medical University Zhu Xianyi Memorial Hospital, Tianjin, Tianjin, 300070, China|Zhejiang Hospital, Hangzhou, Zhejiang, 310013, China|Ningbo First Hospital, Ningbo, Zhejiang, 315010, China|INTENDIA klinika s.r.o., Chrudim III, Chrudim, 537 01, Czechia|MUDr. Alena Vachova, Ceske Budejovice, Jihočeský, 37011, Czechia|MUDr. Tomas Edelsberger, Krnov, Moravskoslezský Kraj, 79401, Czechia|Diahelp s.r.o, Pardubice V, Pardubice, 530 02, Czechia|Milan Kvapil s.r.o., Diabetologicka ambulance, Praha, Praha 4, 14900, Czechia|Diacentrum Brandys n.L. s.r.o., Brandys nad Labem, Praha-vých, 25001, Czechia|MUDr. Tomas Hrdina, Opocno, Rychnov Nad Kněžnou, 517 73, Czechia|Praxis Sauter & Sauter & Vorbach, Wangen im Allgäu, Baden-Württemberg, 88239, Germany|InnoDiab Forschung Gmbh, Essen, Nordrhein-Westfalen, 45136, Germany|Medizentrum Essen Borbeck, Essen, Nordrhein-Westfalen, 45355, Germany|Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz, Ludwigshafen am Rhein, Rheinland-Pfalz, 67059, Germany|Zentrum für klinische Studien, Saint Ingbert, Saarland, 66386, Germany|Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Sachsen, 01307, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|Diabeteszentrum Hamburg West, Hamburg, 22607, Germany|Iatriko Paleou Falirou Medical Center, Paleo Faliro, Attikí (Region), 17562, Greece|Alexandra Hospital, Athens, Attikí, 11528, Greece|Thermi Clinic, Thessaloniki, Thessaloníki, 570 01, Greece|Athens Euroclinic, Athens, 115 21, Greece|Tosaki Clinic for Diabetes and Endocrinology, Nagoya-shi, Aichi, 468-0009, Japan|Kashiwa City Hospital, Kashiwa, Chiba, 277-0825, Japan|Tokuyama Clinic, Mihama-ku,Chiba City, Chiba, 261-0004, Japan|Nippon Kokan Fukuyama Hospital, Fukuyama-shi, Hiroshima, 721-0927, Japan|Hasegawa Medical Clinic, Chitose, Hokkaido, 066-0032, Japan|Manda Memorial Hospital, Sapporo, Hokkaido, 060-0062, Japan|MinamiAkatsukaClinic, Mito, Ibaraki, 311-4153, Japan|Nakakinen clinic, Naka, Ibaraki, 311-0113, Japan|Hayashi Diabetes Internal Medicine Clinic, Chigasaki, Kanagawa, 253-0044, Japan|Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Shimizu Clinic Fusa, Saitama-shi, Saitama, 336-0967, Japan|Kumanomae Nishimura Clinic, Arakawa-ku, Tokyo, 116-0012, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|Hachioji Diabetes Clinic, Hachioji-shi, Tokyo, 192-0083, Japan|Medical Corporation Sato Medical clinic, Ootaku, Tokyo, 143-0015, Japan|Tomonaga Clinic, Shinjuku, Tokyo, 160-0022, Japan|Yoshimura Clinic, Kumamoto, 861-8039, Japan|Abe Clinic, Oita, 870-0039, Japan|Kangwon National University Hospital, Chuncheon-si, Kang-won-do, 24289, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Kyǒnggi-do, 11923, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, Seoul-teuk, 03722, Korea, Republic of|Investigacion En Salud Y Metabolismo Sc, Chihuahua, 31217, Mexico|Centro de Endocrinologia y Nutricion, Caguas, 00725, Puerto Rico|Private Practice - Dr. Paola Mansilla-Letelier, Guaynabo, 00970, Puerto Rico
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