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Clinical Trial Details

Trial ID: L3816
Source ID: NCT05463744
Associated Drug: Insulin Efsitora Alfa
Title: A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Acronym: QWINT-5
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Diabetes
Interventions: DRUG: Insulin Efsitora Alfa|DRUG: Insulin Degludec
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 26 | Secondary: Time in Glucose Range, Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) \[3.9 and 10.0 millimole/liter (mmol/L)\] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26, Week 23 to Week 26|Nocturnal Hypoglycemia Event Rate, The event rate of participant-reported clinically significant nocturnal hypoglycemia (\<54 mg/dL or severe) measured during treatment phase up to week 52., Baseline to Week 52|Change from Baseline in HbA1c, Baseline, Week 52|Change from Baseline in Fasting Glucose, Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG)., Baseline, Week 26 and Baseline, Week 52|Glucose Variability, Glucose variability measured by CGM 4 weeks prior to week 26 and week 52., Week 23 to Week 26 and Week 49 to Week 52|Time in Glucose Range, Time in Glucose Range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) inclusive, measured by continuous glucose monitoring (CGM) 4 weeks prior to week 52., Week 49 to Week 52|Basal Insulin Dose, Week 26 and Week 52|Bolus Insulin Dose, Week 26 and Week 52|Total Insulin Dose, Week 26 and Week 52|Rate of Composite Level 2 and 3 Hypoglycemia Events, Baseline to Week 52|Change from Baseline in Body Weight, Baseline, Week 26 and Baseline, Week 52|Time in Hypoglycemia Range, Time in hypoglycemia range defined as time in hypoglycemia with glucose \<54 mg/dL, measured by CGM 4 weeks prior to week 26 and week 52., Week 23 to Week 26 and Week 49 to Week 52|Time in Hyperglycemia Range, Time in hyperglycemia range defined as glucose \>180 mg/dL, measured by CGM 4 weeks prior to week 26 and week 52., Week 23 to Week 26 and Week 49 to Week 52|Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ), DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia., Baseline, Week 26 and Baseline, Week 52|Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores, SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality., Baseline, Week 26 and Baseline, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 692
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08-12
Completion Date: 2024-05-07
Results First Posted:
Last Update Posted: 2024-07-29
Locations: John Muir Physician Network Research Center, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Northeast Research Institute (NERI), Fleming Island, Florida, 32003, United States|Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care, Fort Lauderdale, Florida, 33312, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Hanson Clinical Research Center, Port Charlotte, Florida, 33952, United States|East Coast Institute for Research at The Jones Center, Macon, Georgia, 31210, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, 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|Cotton O'Neil Clinical Research Center, Topeka, Kansas, 66606, 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|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States|Palm Research Center Sunset, Las Vegas, Nevada, 89148, United States|Research Foundation of SUNY - University of Buffalo, Buffalo, New York, 14221, United States|NYU Langone Hospital - Long Island, Mineola, New York, 11501, United States|NYC Research, New York, New York, 10016, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Biopharma Informatic, LLC, Houston, Texas, 77043, United States|Amir A Hassan, MD, PA, Houston, Texas, 77089, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Texas Diabetes & Endocrinology, P.A., Round Rock, Texas, 78681, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|CEDIC, Caba, Buenos Aires, C1060ABN, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB, Argentina|CIAD Moron, Moron, Buenos Air, B1708EPE, Argentina|Investigaciones Medicas Imoba Srl, Balvanera, Ciudad Autónoma De Buenos Aire, C1056ABH, Argentina|Mautalen Salud e Investigación, Buenos Aires, Ciudad Autónoma De Buenos Aire, C1128AAF, Argentina|Centro Medico Privado CEMAIC, Capital, Córdoba, X5008HHW, Argentina|Centro Medico Privado San Vicente Diabetes, Cordoba, Córdoba, 5006, Argentina|Centro de Salud e Investigaciones Médicas, Santa Rosa, La Pampa, 6300, Argentina|CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, Godoy Cruz, Mendoza, M5501ARP, Argentina|Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L, San Miguel de Tucuman, Tucumán, 4000, Argentina|Centro Medico Privado de Reumatologia, San Miguel De Tucumán, Tucumán, T4000AXL, Argentina|Instituto Médico Especializado (IME), Buenos Aires, 1405, Argentina|Centro Diabetológico Dr. Waitman, Córdoba, 5000, Argentina|Tosaki Clinic for Diabetes and Endocrinology, Nagoya-shi, Aichi, 468-0009, Japan|Manda Memorial Hospital, Sapporo, Hokkaido, 060-0062, Japan|MinamiAkatsukaClinic, Mito, Ibaraki, 311-4153, Japan|Nakakinen clinic, Naka, Ibaraki, 311-0113, Japan|Noritake Clinic, Ushiku, Ibaraki, 300-1207, Japan|Takai Internal Medicine Clinic, Kamakura-shi, Kanagawa, 247-0056, Japan|Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1045, Japan|Shimizu Clinic Fusa, Saitama-shi, Saitama, 336-0967, Japan|The Institute for Adult Disease, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|Hachioji Diabetes Clinic, Hachioji-shi, Tokyo, 192-0083, Japan|Clinic Masae Minami, Fukuoka, 815-0071, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Heiwadai Hospital, Miyazaki, 880-0034, Japan|Abe Clinic, Oita, 870-0039, Japan|Gabinety TERPA, Lublin, Lubelskie, 20-333, Poland|NZOZ Medica, Lublin, Lubelskie, 20-538, Poland|Centrum Medyczne "Diabetika", Radom, Mazowieckie, 26-600, Poland|Centralny Szpital Kliniczny MSWiA w Warszawie, Warszawa, Mazowieckie, 02-507, Poland|NBR Polska, Warszawa, Mazowiecki, 00-710, Poland|Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET, Krakow, Małopolskie, 31-261, Poland|SN ZOZ Lege Artis Poradnia Diabetologiczna, Bialystok, Podlaskie, 15-404, Poland|NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny, Bialystok, Podlaskie, 15-435, Poland|Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|Private Practice - Dr. Janusz Gumprecht, Zabrze, Śląskie, 41-800, Poland|Advanced Clinical Research, LLC, Bayamon, 00959, Puerto Rico|Endocrinologist Metabolic Clinic & Research Institute, San Juan, 921, Puerto Rico|Tatratrial s.r.o., Rožňava, Košický Kraj, 04801, Slovakia|Funkystuff, Nove Zamky, Nitriansky Kraj, 940 01, Slovakia|ENDIAMED s.r.o, Dolny Kubin, Žilinský Kraj, 026 01, Slovakia|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|Taipei Veterans General Hospital, Taipei City, Taipei, 11217, Taiwan|Changhua Christian Hospital, Changhua, 50006, Taiwan|National Cheng Kung University Hospital, Tainan, 704, Taiwan
URL: https://clinicaltrials.gov/show/NCT05463744

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress