A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

NCT ID: NCT05275400

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 986 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2024-05-15

Brief Summary

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

500 U/mL - Insulin Efsitora

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Group Type: EXPERIMENTAL

Insulin Efsitora Alfa

Intervention Type: DRUG

Administered SC

100 U/mL - Insulin Degludec

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Group Type: ACTIVE_COMPARATOR

Insulin Degludec

Intervention Type: DRUG

Administered SC

Interventions

Insulin Efsitora Alfa

Administered SC

Intervention Type: DRUG

Insulin Degludec

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY3209590 and Basal Insulin-FC

Eligibility Criteria

Inclusion Criteria

• Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
• Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
• Have HbA1c value of 6.5% - 10% inclusive, at screening
• Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
• Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

• once daily U100 or U200 of insulin degludec
• once daily U100 or U300 of insulin glargine
• once or twice daily U100 of insulin detemir, or
• once or twice daily human insulin NPH
• acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

• dipeptidyl peptidase (DPP-4) IV inhibitors
• SGLT2 inhibitors
• metformin
• alphaglucosidase inhibitors or,
• Glucagon-Like Peptide-1 (GLP-1) receptor agonists
• Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria

• Have Type 1 diabetes mellitus
• Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
• Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
• Have active or untreated malignancy
• Are pregnant
• Have a significant weight gain or loss the past 3 months
• Have received anytime in the past 6 months, any of the following insulin therapies:

• prandial insulin
• insulin mixtures
• inhaled insulin
• U-500 insulin, or
• continuous subcutaneous insulin infusion therapy
• Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

• acute myocardial infarctions
• cerebrovascular accident (stroke), or
• coronary bypass surgery
• Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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_DIRECTOR

Eli Lilly and Company

Locations

Medical Investigations

Little Rock, Arkansas, United States

John Muir Physician Network Research Center

Concord, California, United States

AMCR Institute

Escondido, California, United States

National Research Institute - Huntington Park

Huntington Park, California, United States

Scripps Whittier Diabetes Institute

La Jolla, California, United States

Diabetes Associates Medical Group

Orange, California, United States

University Clinical Investigators, Inc.

Tustin, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Encore Medical Research

Hollywood, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

West Orange Endocrinology

Ocoee, Florida, United States

Balanced Life Health Care Solutions/SKYCRNG

Lawrenceville, Georgia, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

L-MARC Research Center

Louisville, Kentucky, United States

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, United States

SKY Clinical Research Network Group - Hall

Fayette, Mississippi, United States

Clinvest Research LLC

Springfield, Missouri, United States

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Albany Medical College, Division of Community Endocrinology

Albany, New York, United States

NYC Research

New York, New York, United States

Lillestol Research

Fargo, North Dakota, United States

Aventiv Research Inc

Columbus, Ohio, United States

Intend Research, LLC

Norman, Oklahoma, United States

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, United States

Jefferson Clinical Research Institute (JCRI)

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Gadolin Research

Beaumont, Texas, United States

Dallas Diabetes Research Center

Dallas, Texas, United States

Juno Research

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Southern Endocrinology Associates

Mesquite, Texas, United States

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina

Stat Research S.A.

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Centro Médico Viamonte

Buenos Aires, Ciudad Aut, Argentina

Mautalen Salud e Investigación

Buenos Aires, Ciudad Aut, Argentina

Instituto Centenario

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Instituto Médico Catamarca IMEC

Rosario, Santa Fe Province, Argentina

CEMEDIC

Buenos Aires, , Argentina

CENUDIAB

Ciudad Autónoma de Buenos Aire, , Argentina

Centro Diabetológico Dr. Waitman

Córdoba, , Argentina

DRC Gyógyszervizsgáló Központ

Balatonfüred, Veszprém megye, Hungary

Kanizsai Dorottya Korhaz

Nagykanizsa, Zala County, Hungary

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, Zala County, Hungary

Szent Margit Rendelointézet

Budapest, , Hungary

Szent János Kórház

Budapest, , Hungary

Strazsahegy Medicina Bt.

Budapest, , Hungary

Tokuyama Clinic

Mihama-ku,Chiba City, Chiba, Japan

Yuri Ono Clinic

Sapporo, Hokkaido, Japan

Nakamoto Internal Medicine Clinic

Mito, Ibaraki, Japan

Kozawa Eye Hospital and Diabetes Center

Mito, Ibaraki, Japan

Noritake Clinic

Ushiku, Ibaraki, Japan

Matoba Internal Medicine Clinic

Ebina, Kanagawa, Japan

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, Japan

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, Japan

Shiraiwa Medical Clinic

Kashihara, Osaka, Japan

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan

Shimizu Clinic Fusa

Saitama-shi, Saitama, Japan

Oyama East Clinic

Oyama, Tochigi, Japan

Tokyo-Eki Center-building Clinic

Chuo Ku, Tokyo, Japan

The Institute of Medical Science, Asahi Life Foundation

Chuo-ku, Tokyo, Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Jinnouchi Hospital

Kumamoto, , Japan

Heiwadai Hospital

Miyazaki, , Japan

AMC Nishiumeda Clinic

Osaka, , Japan

Abe Clinic

Ōita, , Japan

OMEDICA Medical Center

Poznan, Greater Poland Voivodeship, Poland

Gaja Poradnie Lekarskie Maciej Wiza

Poznan, Greater Poland Voivodeship, Poland

NZOZ Diab-Endo-Met

Krakow, Lesser Poland Voivodeship, Poland

Private Practice - Dr. Robert Witek

Tarnów, Lesser Poland Voivodeship, Poland

CenterMed Lublin NZOZ

Lublin, Lublin Voivodeship, Poland

Gabinety TERPA

Lublin, Lublin Voivodeship, Poland

NZOZ Medica

Lublin, Lublin Voivodeship, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

Ruda Śląska, Silesian Voivodeship, Poland

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, Poland

IRMED

Piotrkow Trybunalski, Łódź Voivodeship, Poland

GCM Medical Group, PSC - Hato Rey Site

San Juan, PR, Puerto Rico

Mgcendo Llc

San Juan, , Puerto Rico

MediVet s.r.o.

Malacky, Bratislava Region, Slovakia

Human Care s.r.o.

Košice, Košice Region, Slovakia

Areteus s.r.o.

Trebišov, Košice Region, Slovakia

MEDI-DIA s.r.o.

Sabinov, Presov, Slovakia

Diacrin .s.ro.

Bratislava, , Slovakia

DIA-MED CENTRUM s.r.o.

Púchov, , Slovakia

ENDIAMED s.r.o

Dolný Kubín, Žilina Region, Slovakia

Kangwon National University Hospital

Chuncheon, Kang-won-do, South Korea

Yonsei University-Wonju Severance Christian Hospital

Wŏnju, Kang-won-do, South Korea

Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, South Korea

Hanyang University Guri Hospital

Guri-si, Kyǒnggi-do, South Korea

Yeungnam Univeristy Medical Center

Gyeongsan-si, Kyǒngsangbuk-do, South Korea

Inje University Sanggye Paik Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Kyung Hee University Hospital at Gangdong

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teuk, South Korea

Ulsan University Hospital

Ulsan, Ulsan-Kwangyǒkshi, South Korea

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], Spain

Centro Periférico de Especialidades Bola Azul

Almería, Almería, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Quiron Infanta Luisa

Seville, Andalusia, Spain

Clínica Juaneda

Palma de Mallorca, Balears [Baleares], Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Vithas Hospital Sevilla

Seville, Sevilla, Spain

Hospital Universitario de La Ribera

Alzira, Valenciana, Comunitat, Spain

Hospital General Universitario de Valencia

Valencia, Valenciana, Comunitat, Spain

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, , Spain

Chung Shan Medical University Hospital

Taichung, Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Chi Mei Medical Center

Tainan City, Tainan, Taiwan

Fu Jen Catholic University Hospital

New Taipei City, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

United States; Argentina; Hungary; Japan; Poland; Puerto Rico; Slovakia; South Korea; Spain; Taiwan

References

Philis-Tsimikas A, Bergenstal RM, Bailey TS, Jinnouchi H, Thrasher JR, Ilag L, Mitra J, Syring K, Threlkeld RJ. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2279-2289. doi: 10.1016/S0140-6736(25)01044-X. Epub 2025 Jun 22.

Reference Type: DERIVED

PMID: 40562047 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/2r9JxzEnerVifDDkc8VETS

A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Other Identifiers

I8H-MC-BDCU

Identifier Type: OTHER

Identifier Source: secondary_id

2021-002569-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18237

Identifier Type: -

Identifier Source: org_study_id