A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Acronym: QWINT-5
ClinicalTrials.gov ID: NCT05463744
Organization: Eli Lilly and Company
Status: COMPLETED
Study type: INTERVENTIONAL
Phases: PHASE3
Conditions: Type 1 Diabetes
Diabetes
Interventions: DRUG: Insulin Efsitora Alfa
DRUG: Insulin Degludec
Lead sponsor: Eli Lilly and Company (INDUSTRY)
Enrollment: 692 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2022-08-12
Completion date: 2024-05-07
Locations:
facility: John Muir Physician Network Research Center
city: Concord
state: California
country: United States
facility: Valley Research
city: Fresno
state: California
country: United States
facility: Catalina Research Institute, LLC
city: Montclair
state: California
country: United States
facility: Sansum Diabetes Research Institute
city: Santa Barbara
state: California
country: United States
facility: University Clinical Investigators, Inc.
city: Tustin
state: California
country: United States
facility: University of Colorado Anschutz Medical Campus
city: Aurora
state: Colorado
country: United States
facility: Northeast Research Institute (NERI)
city: Fleming Island
state: Florida
country: United States
facility: Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
city: Fort Lauderdale
state: Florida
country: United States
facility: Suncoast Clinical Research, Inc.
city: New Port Richey
state: Florida
country: United States
facility: Hanson Clinical Research Center
city: Port Charlotte
state: Florida
country: United States
facility: East Coast Institute for Research at The Jones Center
city: Macon
state: Georgia
country: United States
facility: East-West Medical Research Institute
city: Honolulu
state: Hawaii
country: United States
facility: Rocky Mountain Clinical Research
city: Idaho Falls
state: Idaho
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
city: West Des Moines
state: Iowa
country: United States
facility: Cotton O'Neil Clinical Research Center
city: Topeka
state: Kansas
country: United States
facility: MedStar Health Research Institute (MedStar Physician Based Research Network)
city: Hyattsville
state: Maryland
country: United States
facility: Endocrine and Metabolic Consultants
city: Rockville
state: Maryland
country: United States
facility: Clinvest Research LLC
city: Springfield
state: Missouri
country: United States
facility: Palm Research Center Tenaya
city: Las Vegas
state: Nevada
country: United States
facility: Palm Research Center Sunset
city: Las Vegas
state: Nevada
country: United States
facility: Research Foundation of SUNY - University of Buffalo
city: Buffalo
state: New York
country: United States
facility: NYU Langone Hospital - Long Island
city: Mineola
state: New York
country: United States
facility: NYC Research
city: New York
state: New York
country: United States
facility: SUNY Upstate Medical University
city: Syracuse
state: New York
country: United States
facility: Thomas Jefferson University Hospital
city: Philadelphia
state: Pennsylvania
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
city: Austin
state: Texas
country: United States
facility: Dallas Diabetes Research Center
city: Dallas
state: Texas
country: United States
facility: North Texas Endocrine Center
city: Dallas
state: Texas
country: United States
facility: Research Institute of Dallas
city: Dallas
state: Texas
country: United States
facility: Biopharma Informatic, LLC
city: Houston
state: Texas
country: United States
facility: Amir A Hassan, MD, PA
city: Houston
state: Texas
country: United States
facility: Southern Endocrinology Associates
city: Mesquite
state: Texas
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
city: Round Rock
state: Texas
country: United States
facility: Rainier Clinical Research Center
city: Renton
state: Washington
country: United States
facility: CEDIC
city: CABA
state: Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autónoma de Buenos Aire
state: Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
city: Ciudad Autonoma de Buenos Aire
state: Buenos Air
country: Argentina
facility: CIAD Moron
city: Morón
state: Buenos Air
country: Argentina
facility: Investigaciones Medicas Imoba Srl
city: Balvanera
state: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Mautalen Salud e Investigación
city: Buenos Aires
state: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro Medico Privado CEMAIC
city: Capital
state: Córdoba Province
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
city: Córdoba
state: Córdoba Province
country: Argentina
facility: Centro de Salud e Investigaciones Médicas
city: Santa Rosa
state: La Pampa Province
country: Argentina
facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
city: Godoy Cruz
state: Mendoza Province
country: Argentina
facility: Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
city: San Miguel de Tucumán
state: Tucumán Province
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: San Miguel de Tucumán
state: Tucumán Province
country: Argentina
facility: Instituto Médico Especializado (IME)
city: Buenos Aires
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Córdoba
country: Argentina
facility: Tosaki Clinic for Diabetes and Endocrinology
city: Nagoya
state: Aichi-ken
country: Japan
facility: Manda Memorial Hospital
city: Sapporo
state: Hokkaido
country: Japan
facility: MinamiAkatsukaClinic
city: Mito
state: Ibaraki
country: Japan
facility: Nakakinen clinic
city: Naka
state: Ibaraki
country: Japan
facility: Noritake Clinic
city: Ushiku
state: Ibaraki
country: Japan
facility: Takai Internal Medicine Clinic
city: Kamakura-shi
state: Kanagawa
country: Japan
facility: Takatsuki Red Cross Hospital
city: Takatsuki
state: Osaka
country: Japan
facility: Shimizu Clinic Fusa
city: Saitama-shi
state: Saitama
country: Japan
facility: The Institute for Adult Disease, Asahi Life Foundation
city: Chuo-ku
state: Tokyo
country: Japan
facility: Hachioji Diabetes Clinic
city: Hachioji-shi
state: Tokyo
country: Japan
facility: Clinic Masae Minami
city: Fukuoka
country: Japan
facility: Jinnouchi Hospital
city: Kumamoto
country: Japan
facility: Heiwadai Hospital
city: Miyazaki
country: Japan
facility: Abe Clinic
city: Ōita
country: Japan
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
city: Krakow
state: Lesser Poland Voivodeship
country: Poland
facility: Gabinety TERPA
city: Lublin
state: Lublin Voivodeship
country: Poland
facility: NZOZ Medica
city: Lublin
state: Lublin Voivodeship
country: Poland
facility: Centrum Medyczne "Diabetika"
city: Radom
state: Masovian Voivodeship
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Warsaw
state: Masovian Voivodeship
country: Poland
facility: NBR Polska
city: Warsaw
state: Mazowiecki
country: Poland
facility: SN ZOZ Lege Artis Poradnia Diabetologiczna
city: Bialystok
state: Podlaskie Voivodeship
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
city: Bialystok
state: Podlaskie Voivodeship
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
city: Gdansk
state: Pomeranian Voivodeship
country: Poland
facility: Private Practice - Dr. Janusz Gumprecht
city: Zabrze
state: Silesian Voivodeship
country: Poland
facility: Advanced Clinical Research, LLC
city: Bayamón
country: Puerto Rico
facility: Endocrinologist Metabolic Clinic & Research Institute
city: San Juan
country: Puerto Rico
facility: Tatratrial s.r.o.
city: Rožňava
state: Košice Region
country: Slovakia
facility: Funkystuff
city: Nové Zámky
state: Nitra Region
country: Slovakia
facility: ENDIAMED s.r.o
city: Dolný Kubín
state: Žilina Region
country: Slovakia
facility: Chung Shan Medical University Hospital
city: Taichung
state: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
state: Taichung
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
state: Tainan
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei City
state: Taipei
country: Taiwan
facility: Changhua Christian Hospital
city: Changhua
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan

Summary:
The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.