A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

NCT05463744 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 18263I8H-MC-BDCY2021-005892-38
• Study Type: interventional
• Target: 692
• Locations: 7 countries
• Sites: 83

Brief 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.

Conditions

Type 1 Diabetes; Diabetes

Keywords

Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis]

  HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with treatment + country + CGM use prior to study entry \[yes/no\]+ carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.

  Baseline, Week 26

Secondary Outcomes (19)

• Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis]

  Baseline, Week 26

• Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26

  Week 23 to Week 26

• Nocturnal Hypoglycemia Event Rate

  Baseline up to Week 52

• Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]

  Baseline, Week 52

• Change From Baseline in Fasting Blood Glucose

  Baseline, Week 26, and Week 52

Study Arms (2)

Insulin Efsitora Alfa

EXPERIMENTAL

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.

Drug: Insulin Efsitora Alfa

Insulin Degludec

ACTIVE COMPARATOR

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.

Drug: Insulin Degludec

Interventions

Insulin Efsitora Alfa DRUG

Administered SC

Also known as: LY3209590 and Basal Insulin-FC

Insulin Efsitora Alfa

Insulin Degludec DRUG

Administered SC

Insulin Degludec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
• 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)

You may not qualify if:

• Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (83)

John Muir Physician Network Research Center

Concord, California, 94520, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Northeast Research Institute (NERI)

Fleming Island, Florida, 32003, United States

Location

Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, 33312, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Hanson Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

East Coast Institute for Research at The Jones Center

Macon, Georgia, 31210, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, 20782, United States

Location

Endocrine and Metabolic Consultants

Rockville, Maryland, 20852, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Palm Research Center Tenaya

Las Vegas, Nevada, 89128, United States

Location

Palm Research Center Sunset

Las Vegas, Nevada, 89148, United States

Location

Research Foundation of SUNY - University of Buffalo

Buffalo, New York, 14221, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

NYC Research

New York, New York, 10016, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Amir A Hassan, MD, PA

Houston, Texas, 77089, United States

Location

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

Location

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, 78681, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

CEDIC

CABA, Buenos Aires, C1060ABN, Argentina

Location

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina

Location

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB, Argentina

Location

CIAD Moron

Morón, Buenos Air, B1708EPE, Argentina

Location

Investigaciones Medicas Imoba Srl

Balvanera, Ciudad Autónoma de Buenos Aire, C1056ABH, Argentina

Location

Mautalen Salud e Investigación

Buenos Aires, Ciudad Autónoma de Buenos Aire, C1128AAF, Argentina

Location

Centro Medico Privado CEMAIC

Capital, Córdoba Province, X5008HHW, Argentina

Location

Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, 5006, Argentina

Location

Centro de Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, 6300, Argentina

Location

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, M5501ARP, Argentina

Location

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Instituto Médico Especializado (IME)

Buenos Aires, 1405, Argentina

Location

Centro Diabetológico Dr. Waitman

Córdoba, 5000, Argentina

Location

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, Aichi-ken, 468-0009, Japan

Location

Manda Memorial Hospital

Sapporo, Hokkaido, 060-0062, Japan

Location

MinamiAkatsukaClinic

Mito, Ibaraki, 311-4153, Japan

Location

Nakakinen clinic

Naka, Ibaraki, 311-0113, Japan

Location

Noritake Clinic

Ushiku, Ibaraki, 300-1207, Japan

Location

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki, Osaka, 569-1045, Japan

Location

Shimizu Clinic Fusa

Saitama-shi, Saitama, 336-0967, Japan

Location

The Institute for Adult Disease, Asahi Life Foundation

Chuo-ku, Tokyo, 103-0002, Japan

Location

Hachioji Diabetes Clinic

Hachioji-shi, Tokyo, 192-0083, Japan

Location

Clinic Masae Minami

Fukuoka, 815-0071, Japan

Location

Jinnouchi Hospital

Kumamoto, 862-0976, Japan

Location

Heiwadai Hospital

Miyazaki, 880-0034, Japan

Location

Abe Clinic

Ōita, 870-0039, Japan

Location

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, 31-261, Poland

Location

Gabinety TERPA

Lublin, Lublin Voivodeship, 20-333, Poland

Location

NZOZ Medica

Lublin, Lublin Voivodeship, 20-538, Poland

Location

Centrum Medyczne "Diabetika"

Radom, Masovian Voivodeship, 26-600, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

NBR Polska

Warsaw, Mazowiecki, 00-710, Poland

Location

SN ZOZ Lege Artis Poradnia Diabetologiczna

Bialystok, Podlaskie Voivodeship, 15-404, Poland

Location

NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny

Bialystok, Podlaskie Voivodeship, 15-435, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Private Practice - Dr. Janusz Gumprecht

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Advanced Clinical Research, LLC

Bayamón, 00959, Puerto Rico

Location

Endocrinologist Metabolic Clinic & Research Institute

San Juan, 921, Puerto Rico

Location

Tatratrial s.r.o.

Rožňava, Košice Region, 04801, Slovakia

Location

Funkystuff

Nové Zámky, Nitra Region, 940 01, Slovakia

Location

ENDIAMED s.r.o

Dolný Kubín, Žilina Region, 026 01, Slovakia

Location

Chung Shan Medical University Hospital

Taichung, Taichung, 402, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taichung, 407, Taiwan

Location

Chi Mei Medical Center

Tainan, Tainan, 71004, Taiwan

Location

Taipei Veterans General Hospital

Taipei City, Taipei, 11217, Taiwan

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 39270686 DERIVED

Related Links

• A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 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

  Eli Lilly and Company

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: August 12, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AR (14); US (34); PL (10); PR (2); SL (3); TW (6); JP (14)