Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5355
Source ID: NCT05275400
Associated Drug: Insulin Efsitora Alfa
Title: A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin Efsitora Alfa|DRUG: Insulin Degludec
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin., Baseline, Week 26 | Secondary: Nocturnal Hypoglycemia Event Rate, The event rate of participant-reported clinically significant nocturnal hypoglycemia (\<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78., Baseline to Week 78|Time in Range, Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session., Week 22 to Week 26|Change from Baseline in Fasting Glucose, Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG)., Baseline, Week 26|Weekly Insulin dose, The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary., Week 26|Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate, The event rate of participant-reported clinically significant nocturnal hypoglycemia (\<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase., Baseline to Week 78|Change from Baseline in Body Weight, Change from baseline in body weight, Baseline, Week 78|Time in Hypoglycemia Range, Time in hypoglycemia range defined as time in hypoglycemia with glucose \<54 mg/dL measured during the CGM session., Week 22 to Week 26|Time in Hyperglycemia Range, Time in hyperglycemia range defined as time in hyperglycemia with glucose \>180 mg/dL measured during the CGM session., Week 22 to Week 26|Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D), TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment., Baseline, Week 26|Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ), DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia., Baseline, Week 26|Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ), DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia., Baseline, Week 78
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 986
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-08
Completion Date: 2024-05-15
Results First Posted:
Last Update Posted: 2024-05-28
Locations: Medical Investigations, Little Rock, Arkansas, 72211, United States|John Muir Physician Network Research Center, Concord, California, 94520, United States|AMCR Institute, Escondido, California, 92025, United States|National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|Diabetes Associates Medical Group, Orange, California, 92868, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Encore Medical Research, Hollywood, Florida, 33021, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|West Orange Endocrinology, Ocoee, Florida, 34761, United States|Balanced Life Health Care Solutions/SKYCRNG, Lawrenceville, Georgia, 30046, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States|HealthPartners Institute dba International Diabetes Center, Minneapolis, Minnesota, 55416, United States|SKY Clinical Research Network Group - Hall, Fayette, Mississippi, 39069, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States|Albany Medical College, Division of Community Endocrinology, Albany, New York, 12203, United States|NYC Research, New York, New York, 10016, United States|Lillestol Research, Fargo, North Dakota, 58104, United States|Aventiv Research Inc, Columbus, Ohio, 43213, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Jefferson Clinical Research Institute (JCRI), Philadelphia, Pennsylvania, 19114, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Gadolin Research, Beaumont, Texas, 77702, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Juno Research, Houston, Texas, 77040, United States|Biopharma Informatic, LLC, Houston, Texas, 77043, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Texas Diabetes & Endocrinology, P.A., Round Rock, Texas, 78681, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina|Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Buenos Aires, 7600, Argentina|Go Centro Medico San Nicolás, San Nicolas, Buenos Aires, 2900, Argentina|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB, Argentina|Stat Research S.A., Ciudad Autónoma de Buenos Aire, Buenos Air, C1023AAB, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Aut, C1120AAC, Argentina|Mautalen Salud e Investigación, Buenos Aires, Ciudad Aut, C1128AAF, Argentina|Instituto Centenario, Caba, Ciudad Autónoma De Buenos Aire, 1204, Argentina|Centro Medico Privado CEMAIC, Capital, Córdoba, X5008HHW, Argentina|CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, Godoy Cruz, Mendoza, M5501ARP, Argentina|Instituto Médico Catamarca IMEC, Rosario, Santa Fe, 2000, Argentina|CEMEDIC, Buenos Aires, 1407, Argentina|CENUDIAB, Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina|Centro Diabetológico Dr. Waitman, Córdoba, 5000, Argentina|DRC Gyógyszervizsgáló Központ, Balatonfüred, Veszprém, 8230, Hungary|Kanizsai Dorottya Korhaz, Nagykanizsa, Zala, 8800, Hungary|Zala Megyei Szent Rafael Kórház, Zalaegerszeg, Zala, 8900, Hungary|Szent Margit Rendelointézet, Budapest, 1032, Hungary|Szent János Kórház, Budapest, 1125, Hungary|Strazsahegy Medicina Bt., Budapest, H1171, Hungary|Tokuyama Clinic, Mihama-ku,Chiba City, Chiba, 261-0004, Japan|Yuri Ono Clinic, Sapporo, Hokkaido, 060-0001, Japan|Nakamoto Internal Medicine Clinic, Mito, Ibaraki, 310-0826, Japan|Kozawa Eye Hospital and Diabetes Center, Mito, Ibaraki, 310-0845, Japan|Noritake Clinic, Ushiku, Ibaraki, 300-1207, Japan|Matoba Internal Medicine Clinic, Ebina, Kanagawa, 243-0432, Japan|Takai Internal Medicine Clinic, Kamakura-shi, Kanagawa, 247-0056, Japan|Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Shiraiwa Medical Clinic, Kashiwara, Osaka, 582-0005, Japan|Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1045, Japan|Shimizu Clinic Fusa, Saitama-shi, Saitama, 336-0967, Japan|Oyama East Clinic, Oyama, Tochigi, 323-0022, Japan|Tokyo-Eki Center-building Clinic, Chuo Ku, Tokyo, 103-0027, Japan|The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|Medical Corporation Chiseikai Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Heiwadai Hospital, Miyazaki, 880-0034, Japan|Abe Clinic, Oita, 870-0039, Japan|AMC Nishiumeda Clinic, Osaka, 530-0001, Japan|Kangwon National University Hospital, Chuncheon-si, Kang-won-do, 24289, Korea, Republic of|Yonsei University-Wonju Severance Christian Hospital, Wonju, Kang-won-do, 26426, Korea, Republic of|Korea University Ansan Hospital, Ansan-si, Kyǒnggi-do, 15355, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Kyǒnggi-do, 11923, Korea, Republic of|Yeungnam Univeristy Medical Center, Gyeongsan-si, Kyǒngsangbuk-do, 42415, Korea, Republic of|Inje University Sanggye Paik Hospital, Seoul, Seoul-teukbyeolsi [Seoul], 01757, Korea, Republic of|Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of|Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of|Hallym University Kangnam Sacred Heart Hospital, Seoul, Seoul-teukbyeolsi [Seoul], 07441, Korea, Republic of|Kyung Hee University Hospital at Gangdong, Seoul, Seoul-teukbyeolsi [Seoul], 134-090, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, Seoul-teuk, 03722, Korea, Republic of|Ulsan University Hospital, Ulsan, Ulsan-Kwangyǒkshi, 44033, Korea, Republic of|CenterMed Lublin NZOZ, Lublin, Lubelskie, 20-044, Poland|Gabinety TERPA, Lublin, Lubelskie, 20-333, Poland|NZOZ Medica, Lublin, Lubelskie, 20-538, Poland|NZOZ Diab-Endo-Met, Krakow, Małopolskie, 31-261, Poland|Private Practice - Dr. Robert Witek, Tarnów, Małopolskie, 33-100, Poland|Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|OMEDICA Medical Center, Poznan, Wielkopolskie, 60-111, Poland|Gaja Poradnie Lekarskie Maciej Wiza, Poznan, Wielkopolskie, 61-251, Poland|Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz, Łódzkie, 90338, Poland|IRMED, Piotrkow Trybunalski, Łódzkie, 97-300, Poland|NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ruda Slaska, Śląskie, 41-709, Poland|GCM Medical Group, PSC - Hato Rey Site, San Juan, 00917, Puerto Rico|Mgcendo Llc, San Juan, 00921, Puerto Rico|MediVet s.r.o., Malacky, Bratislavský Kraj, 901 01, Slovakia|Human Care s.r.o., Kosice, Košický Kraj, 04012, Slovakia|Areteus s.r.o., Trebisov, Košický Kraj, 075 01, Slovakia|MEDI-DIA s.r.o., Sabinov, Prešovský Kraj, 083 01, Slovakia|Diacrin .s.ro., Bratislava, 84102, Slovakia|DIA-MED CENTRUM s.r.o., Puchov, 020 01, Slovakia|ENDIAMED s.r.o, Dolny Kubin, Žilinský Kraj, 026 01, Slovakia|CHUAC-Complejo Hospitalario Universitario A Coruña, A Coruña, A Coruña [La Coruña], 15006, Spain|Centro Periférico de Especialidades Bola Azul, Almeria, Almería, 04009, Spain|Hospital Universitario Virgen de la Victoria, Malaga, Andalucía, 29010, Spain|Hospital Quiron Infanta Luisa, Sevilla, Andalucía, 41010, Spain|Clínica Juaneda, Palma de Mallorca, Balears [Baleares], 07014, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], 08035, Spain|Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, 39008, Spain|Vithas Hospital Sevilla, Seville, Sevilla, 41950, Spain|Hospital Universitario de La Ribera, Alzira, Valenciana, Comunitat, 46600, Spain|Hospital General Universitario de Valencia, Valencia, Valenciana, Comunitat, 46014, Spain|Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE), Sevilla, 41003, Spain|Chung Shan Medical University Hospital, Taichung City, Taichung, 402, Taiwan|Taichung Veterans General Hospital, Taichung City, Taichung, 407, Taiwan|Chi Mei Medical Center, Tainan City, Tainan, 71004, Taiwan|Fu Jen Catholic University Hospital, New Taipei, 24352, Taiwan|National Cheng Kung University Hospital, Tainan, 704, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT05275400

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress