A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
NCT ID: NCT05463744
Last Updated: 2025-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
692 participants
INTERVENTIONAL
2022-08-12
2024-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin Efsitora Alfa
Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 units per milliliter (U/mL) Insulin Lispro) received 500 U/mL of insulin efsitora alfa administered once weekly (QW) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.
Insulin Efsitora Alfa
Administered SC
Insulin Degludec
Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 U/mL Insulin Lispro) received 100 U/mL of Insulin Degludec administered once daily (QD) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.
Insulin Degludec
Administered SC
Interventions
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Insulin Efsitora Alfa
Administered SC
Insulin Degludec
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
* Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
* Have a body mass index of ≤35 kilogram/square meter (kg/m²)
Exclusion Criteria
* Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
* Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST
Role: STUDY_CHAIR
Eli Lilly and Company
Locations
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John Muir Physician Network Research Center
Concord, California, United States
Valley Research
Fresno, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
East Coast Institute for Research at The Jones Center
Macon, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Clinvest Research LLC
Springfield, Missouri, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Palm Research Center Sunset
Las Vegas, Nevada, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
NYC Research
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Amir A Hassan, MD, PA
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
CEDIC
CABA, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina
CIAD Moron
Morón, Buenos Air, Argentina
Investigaciones Medicas Imoba Srl
Balvanera, Ciudad Autónoma de Buenos Aire, Argentina
Mautalen Salud e Investigación
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, Argentina
Centro Medico Privado San Vicente Diabetes
Córdoba, Córdoba Province, Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Mendoza Province, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Instituto Médico Especializado (IME)
Buenos Aires, , Argentina
Centro Diabetológico Dr. Waitman
Córdoba, , Argentina
Tosaki Clinic for Diabetes and Endocrinology
Nagoya, Aichi-ken, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, Japan
MinamiAkatsukaClinic
Mito, Ibaraki, Japan
Nakakinen clinic
Naka, Ibaraki, Japan
Noritake Clinic
Ushiku, Ibaraki, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan
Shimizu Clinic Fusa
Saitama-shi, Saitama, Japan
The Institute for Adult Disease, Asahi Life Foundation
Chuo-ku, Tokyo, Japan
Hachioji Diabetes Clinic
Hachioji-shi, Tokyo, Japan
Clinic Masae Minami
Fukuoka, , Japan
Jinnouchi Hospital
Kumamoto, , Japan
Heiwadai Hospital
Miyazaki, , Japan
Abe Clinic
Ōita, , Japan
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
Gabinety TERPA
Lublin, Lublin Voivodeship, Poland
NZOZ Medica
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne "Diabetika"
Radom, Masovian Voivodeship, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, Masovian Voivodeship, Poland
NBR Polska
Warsaw, Mazowiecki, Poland
SN ZOZ Lege Artis Poradnia Diabetologiczna
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Private Practice - Dr. Janusz Gumprecht
Zabrze, Silesian Voivodeship, Poland
Advanced Clinical Research, LLC
Bayamón, , Puerto Rico
Endocrinologist Metabolic Clinic & Research Institute
San Juan, , Puerto Rico
Tatratrial s.r.o.
Rožňava, Košice Region, Slovakia
Funkystuff
Nové Zámky, Nitra Region, Slovakia
ENDIAMED s.r.o
Dolný Kubín, Žilina Region, Slovakia
Chung Shan Medical University Hospital
Taichung, Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taichung, Taiwan
Chi Mei Medical Center
Tainan City, Tainan, Taiwan
Taipei Veterans General Hospital
Taipei City, Taipei, Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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Bergenstal RM, Weinstock RS, Mathieu C, Onishi Y, Vijayanagaram V, Katz ML, Carr MC, Chang AM. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial. Lancet. 2024 Sep 21;404(10458):1132-1142. doi: 10.1016/S0140-6736(24)01804-X. Epub 2024 Sep 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)
Other Identifiers
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I8H-MC-BDCY
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005892-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18263
Identifier Type: -
Identifier Source: org_study_id
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