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Clinical Trial Details

Trial ID: L6229
Source ID: NCT05462756
Associated Drug: Insulin Efsitora Alfa
Title: A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections
Acronym: QWINT-4
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Type 2 Diabetes Treated With Insulin
Interventions: DRUG: Insulin Efsitora Alfa|DRUG: Insulin Lispro (U100)|DRUG: Insulin Glargine (U100)
Outcome Measures: Primary: Change from Baseline in HbA1c, Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin glargine on glycemic control in adult participants with type 2 diabetes on multiple daily injections., Baseline, Week 26 | Secondary: Percentage of Participants Achieving HbA1c <7% without Nocturnal Hypoglycemia, Percentage of participants achieving HbA1c \<7% without nocturnal hypoglycemia \[\<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L) or severe during treatment phase up to week 26., Week 26|Nocturnal Hypoglycemia Event Rate, The event rate of participant-reported clinically significant nocturnal hypoglycemia \<54 mg/dL (3.0 mmol/L) or severe) measured during treatment phase up to week 26., Baseline 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|Time in Glucose Range, Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session, Week 22 to Week 26|Time in Hypoglycemia Range, Time in hypoglycemia range with glucose \<54 mg/dL (3.0 mmol/L), measured by CGM, Week 22 to Week 26|Time in Hyperglycemia Range, Time in hyperglycemia range with glucose \>180 mg/dL (10.0 mmol/L), measured by CGM, Week 22 to Week 26|Glucose Variability, Glucose variability measured during the CGM session, Week 22 to Week 26|Basal Insulin Dose, Week 26|Bolus Insulin Dose, Week 26|Total Insulin Dose, Week 26|Basal Insulin Dose to Total Insulin Dose Ratio, Week 26|Hypoglycemia Event Rate, Incidence and rate of composite of level 2 and 3 hypoglycemia event, Baseline to Week 26|Change from Baseline in Body Weight, Baseline, Week 26|Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ), The DID-EQ is a self-administered 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for T2D. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics., Week 26
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 730
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08-11
Completion Date: 2024-02-27
Results First Posted:
Last Update Posted: 2024-08-22
Locations: CMR of Greater New Haven, LLC, Hamden, Connecticut, 06517, United States|Tampa Bay Medical Research, Clearwater, Florida, 33761, United States|Panax Clinical Research, Miami Lakes, Florida, 33014, United States|Encore Medical Research - Weston, Weston, Florida, 33331, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|MedStar Good Samaritan Hospital, Baltimore, Maryland, 21239, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, 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|Remington Davis Clinical Research, Columbus, Ohio, 43215, United States|Aventiv Research, Dublin, Ohio, 43016, United States|Heritage Valley Multispecialty Group, Inc, Beaver, Pennsylvania, 15009, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78749, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|Biopharma Informatic, LLC, Houston, Texas, 77043, United States|Research Institute of Dallas, Plano, Texas, 75093, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, 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|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|Mautalen Salud e Investigación, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1128AAF, Argentina|CIPREC, Caba, Ciudad Autónoma De Buenos Aires, C1061AAS, Argentina|Instituto Centenario, Caba, Ciudad Autónoma De Buenos Aire, 1204, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, C1425AGC, Argentina|Instituto Médico Río Cuarto, Río Cuarto, Córdoba, 5800, Argentina|Centro de Salud e Investigaciones Médicas, Santa Rosa, La Pampa, 6300, Argentina|Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta, Rosario, Santa Fe, 2000, Argentina|Instituto Médico Catamarca IMEC, Rosario, Santa Fe, 2000, Argentina|Centro de Investigaciones Médicas Tucuman, San Miguel De Tucumán, Tucumán, T4000AXL, Argentina|CENUDIAB, Ciudad Autónoma de Buenos Aires, C1440AAD, Argentina|Instituto de Investigaciones Clínicas Córdoba, Córdoba, 5000, Argentina|Centro de Investigaciones Clinicas del Litoral, Santa Fe, 3000, Argentina|ClinPhenomics GmbH & Co KG, Frankfurt, Hessen, 60596, Germany|InnoDiab Forschung Gmbh, Essen, Nordrhein-Westfalen, 45136, Germany|Institut für Diabetesforschung GmbH Münster, Münster, Nordrhein-Westfalen, 48145, Germany|Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage, Münster, Nordrhein-Westfalen, 48153, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|Diabetespraxis Mergentheim, Bad Mergentheim, 97980, Germany|Diabeteszentrum Hamburg West, Hamburg, 22607, Germany|Life Care Hospital and Research Centre, Bangalore, Karnataka, 560092, India|Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Mumbai, Maharashtra, 400008, India|BSES MG Hospital, Mumbai, Maharashtra, 400058, India|Madras Diabetes Research Foundation, Chennai, Tamil Nadu, 600086, India|Osmania General Hospital, Hyderabad, Telangana, 500012, India|Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, 160012, India|Osepdale Civile Fr 5, Ceccano, Frosinone, 03023, Italy|"Fatebenefratelli Isola Tiberina - Gemelli Isola", Roma, Lazio, 00186, Italy|Ospedale san Giovanni di Dio-Diabetologia, Olbia, Sardegna, 07026, Italy|INRCA Ancona, Ancona, 60125, Italy|IRCCS - AOU di Bologna, Bologna, 40138, Italy|Azienda Ospedaliera Spedali Civili di Brescia, Brescia, 25123, Italy|Azienda Ospedaliera Mater Domini, Catanzaro, 88100, Italy|Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli, Palermo, 90127, Italy|Private Practice - Dr. Arechavaleta Granell Maria del Rosario, Guadalajara, Jalisco, 44670, Mexico|Unidad de Investigación Clínica y Atención Médica HEPA, Guadalajara, Jalisco, 44670, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 66460, Mexico|Unidad Médica para la Salud Integral, San Nicolás de los Garza, Nuevo León, 66465, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C., Ciudad Madero, Tamaulipas, 89440, Mexico|Investigacion En Salud Y Metabolismo Sc, Chihuahua, 31217, Mexico|Centro de Endocrinologia Alcantara Gonzalez, Bayamon, 00959, Puerto Rico|Manati Center for Clinical Research, Manati, 00674, Puerto Rico|CHUAC-Complejo Hospitalario Universitario A Coruña, A Coruña, A Coruña [La Coruña], 15006, Spain|Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval, Ferrol, A Coruña [La Coruña], 15405, Spain|Hospital Universitario Virgen de la Victoria, Malaga, Andalucía, 29010, Spain|Hospital Universitari Son Espases, Palma, Balears [Baleares], 07120, Spain|Hospital Clínico Universitario de Valladolid, Valladolid, Castilla Y León, 47010, Spain|Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya [Cataluña], 08041, Spain|Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón, Madrid, 28223, 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|Hospital Universitario San Cecilio, Granada, 18016, Spain|Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE), Sevilla, 41003, Spain
URL: https://clinicaltrials.gov/show/NCT05462756

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