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Clinical Trial Details

Trial ID: L5767
Source ID: NCT05662332
Associated Drug: Insulin Efsitora Alfa
Title: A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Acronym: QWINT-1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|T2D
Interventions: DRUG: Insulin Efsitora Alfa|DRUG: Insulin Glargine
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine, Baseline, Week 52 | Secondary: Change from Baseline in HbA1c, Demonstrate superiority of insulin efsitora alfa compared to insulin glargine, Baseline, Week 52|Change from Baseline in Fasting Glucose, Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG), Baseline, Week 52|Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence, Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period., Week 52|Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence, Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period., Week 52|Change from Baseline in Body Weight, Baseline, Week 52|Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction, DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia., Baseline, Week 52|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 treatments., Baseline, Week 52|Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity, SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication)., Baseline, Week 52|Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics, DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes., Baseline, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 795
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-14
Completion Date: 2024-07-19
Results First Posted:
Last Update Posted: 2024-10-30
Locations: Cahaba Research, Birmingham, Alabama, 35242, United States|Syed Research Consultants Llc, Sheffield, Alabama, 35660, United States|AMCR Institute, Escondido, California, 92025, United States|Velocity Clinical Research, Gardena, Gardena, California, 90247, United States|National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|Diabetes Associates Medical Group, Orange, California, 92868, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Millennium Clinical Trials, Thousand Oaks, California, 93065, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Clinical Research of West Florida, Inc. (Clearwater), Clearwater, Florida, 33765, United States|Suncoast Research Group, Miami, Florida, 33135, United States|Clinical Research of West Florida, Tampa, Florida, 33606, United States|Center for Advanced Research & Education, Gainesville, Georgia, 30501, United States|Pacific Diabetes & Endocrine Center, Honolulu, Hawaii, 96813, United States|Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative, Springfield, Illinois, 62711, United States|American Health Network of Indiana, LLC - Franklin, Franklin, Indiana, 46131, United States|American Health Network of Indiana, LLC - Muncie, Muncie, Indiana, 47304, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|University Of Nebraska Medical Center, Omaha, Nebraska, 68198-4130, United States|Mid Hudson Medical Research, New Windsor, New York, 12553, United States|Meridian Clinical Research, LLC, Vestal, New York, 13850, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Decpa, Llc, Feasterville-Trevose, Pennsylvania, 19053, United States|Office 18, Pittsburgh, Pennsylvania, 15236, United States|WR-Clinsearch, LLC, Chattanooga, Tennessee, 37421, United States|Private Practice - Dr. Osvaldo A. Brusco, Corpus Christi, Texas, 78414, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Prime Revival Research Institute, Flower Mound, Texas, 75028, United States|Endocrine Associates, Houston, Texas, 77004, United States|Endocrine Ips, Pllc, Houston, Texas, 77079, United States|North Hills Family Medicine/North Hills Medical Research, North Richland Hills, Texas, 76180, United States|Texas Valley Clinical Research, Weslaco, Texas, 78596, United States|Eastside Research Associates, Redmond, Washington, 98052, 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|DIM Clínica Privada, Ramos Mejía, Buenos Aires, 1704, Argentina|Go Centro Medico San Nicolás, San Nicolas, Buenos Aires, 2900, Argentina|Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires, Buenos Air, C1419AHN, Argentina|Stat Research S.A., Buenos Aires, Ciudad Aut, C1023AAB, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Aut, C1120AAC, Argentina|Glenny Corp, Buenos Aires, Ciudad Aut, C1430CKE, Argentina|CEMEDIAB, C.a.b.a., Ciudad Aut, C1205AAO, Argentina|Investigaciones Medicas Imoba Srl, Buenos Aires, Ciudad Autónoma De Buenos Aire, C1056ABH, Argentina|CIPREC, Buenos Aires, Ciudad Autónoma De Buenos Aire, C1061AAS, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, C1425AGC, Argentina|Centro Medico Privado San Vicente Diabetes, Cordoba, Córdoba, 5006, Argentina|Instituto Médico Río Cuarto, Río Cuarto, Córdoba, 5800, Argentina|CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, Godoy Cruz, Mendoza, M5501ARP, Argentina|Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica, Rosario, Santa Fe, 2000, Argentina|Clínica Mayo, San Miguel de Tucuman, Tucumán, 4000, Argentina|Fundación Respirar, Buenos Aires, C1426ABP, Argentina|CENUDIAB, Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina|Centro de Diagnóstico y Rehabilitación (CEDIR), Santa Fe, 3000, Argentina|Sanatorio Norte, Santiago del Estero, 4200, Argentina|RM Pharma Specialists, Mexico City, Distrito Federal, 03100, Mexico|Instituto Jalisciense de Investigacion en Diabetes y Obesidad, Guadalajara, Jalisco, 04460, Mexico|Diseno y Planeacion en Investigacion Medica, Guadalajara, Jalisco, 44130, Mexico|Instituto de Diabetes, Obesidad y Nutricion, Cuernavaca, Morelos, 62250, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 64460, 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|Medical Care and Research SA de CV, Merida, Yucatán, 97070, Mexico|Investigacion En Salud Y Metabolismo Sc, Chihuahua, 31217, Mexico|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico|Latin Clinical Trial Center, San Juan, 00909, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT05662332

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress