A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

NCT05362058 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 18262I8H-MC-BDCX2021-005891-21
• Study Type: interventional
• Target: 928
• Locations: 11 countries
• Sites: 113

Brief Summary

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.

Conditions

Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  * HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. * Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.

  Baseline, Week 52

Secondary Outcomes (18)

• Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis]

  Baseline, Week 52

• Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis]

  Baseline, Week 52

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

  Baseline, Week 52

• Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52

  Week 48 to Week 52

• Change From Baseline in HbA1c at Week 26 [Superiority Analysis]

  Baseline, Week 26

Study Arms (2)

500 U/mL - Insulin Efsitora Alfa

EXPERIMENTAL

* Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.

Drug: Insulin Efsitora Alfa

100 U/mL - Insulin Degludec

ACTIVE COMPARATOR

* Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.

Drug: Insulin Degludec

Interventions

Insulin Efsitora Alfa DRUG

Administered SC

Also known as: LY3209590 and Basal Insulin-FC

500 U/mL - Insulin Efsitora Alfa

Insulin Degludec DRUG

Administered SC

100 U/mL - 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 diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
• Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
• Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
• These antihyperglycemic medications are accepted in the study
• dipeptidyl peptidase-4 (DPP-4) inhibitors
• sodium-glucose cotransporter 2 (SGLT2) inhibitors
• biguanides, such as metformin
• alpha-glucosidase inhibitors
• glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
• Sulfonylureas, or
• Thiazolidinediones.
• Are insulin naïve.
• Exceptions:
• short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
• Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).

You may not qualify if:

• Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
• Have a history of greater than (\>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
• Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
• Acute myocardial infarction
• Cerebrovascular accident (stroke), or
• Coronary bypass surgery.
• Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
• Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (113)

Neighborhood Healthcare Institute of Health

Escondido, California, 92025, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

NorCal Medical Research, Inc

Greenbrae, California, 94904, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Southern California Dermatology, Inc.

Santa Ana, California, 92701, United States

Location

New West Physicians Clinical Research

Golden, Colorado, 80401, United States

Location

New England Research Associates, LLC

Bridgeport, Connecticut, 06606, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

Location

East Coast Institute for Research - Canton

Canton, Georgia, 30114, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

Springfield, Illinois, 62711, United States

Location

Qualmedica Research, LLC

Evansville, Indiana, 47715, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Qualmedica Research

Bowling Green, Kentucky, 42101, 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

SKY Clinical Research Network Group-Quinn

Ridgeland, Mississippi, 39157, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Clarity Clinical Research

East Syracuse, New York, 13057, United States

Location

Great Lakes Medical Research, LLC

Westfield, New York, 14787, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Lucas Research, Inc

Morehead City, North Carolina, 28557, United States

Location

Intend Research, LLC

Norman, Oklahoma, 73069, United States

Location

Jefferson Clinical Research Institute (JCRI)

Philadelphia, Pennsylvania, 19114, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

Juno Research

Houston, Texas, 77040, United States

Location

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

Location

North Hills Family Medicine/North Hills Medical Research

North Richland Hills, Texas, 76180, United States

Location

Multicare Institute for Research and Innovation

Spokane, Washington, 99202, United States

Location

CEDOES

Vitória, Espírito Santo, 29055450, Brazil

Location

Cline Research Center

Curitiba, Paraná, 80030-480, Brazil

Location

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, 13034-685, Brazil

Location

Hospital São Lucas de Copacabana

Rio de Janeiro, 22061-080, Brazil

Location

CPQuali Pesquisa Clínica

São Paulo, 01228-000, Brazil

Location

CPCLIN

São Paulo, 01228-200, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010, Brazil

Location

LMC Diabetes & Endocrinology

Brampton, Ontario, L6S 0C6, Canada

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

LMC Manna Research

Ottawa, Ontario, K2J 0V2, Canada

Location

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, N7T 4X3, Canada

Location

Centricity Research Etobicoke Endocrinology

Toronto, Ontario, M9R 4E1, Canada

Location

Fadia El Boreky Medicine

Waterloo, Ontario, N2J 1C4, Canada

Location

9109-0126 Quebec Inc.

Montreal, Quebec, H4N 2W2, Canada

Location

Beijing Pinggu District Hospital

Beijing, Beijing Municipality, 101200, China

Location

Chongqing General Hospital

Chongqing, Chongqing Municipality, 400014, China

Location

Hebei Medical University - Harrison International Peace Hospital

Hengshui Shi, Hebei, 053000, China

Location

The First Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, 471003, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The First People's Hospital of Yueyang

Yueyang, Hunan, 414000, China

Location

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213164, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

Location

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, Jiangsu, 211100, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

The Affiliated Jiangyin Hospital of Southeast University Medical College

Wuxi, Jiangsu, 214400, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China

Location

The Third Hospital of Nanchang

Nanchang, Jiangxi, 330009, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Shanghai Putuo District Center Hospital

Shanghai, Shanghai Municipality, 200062, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Chengdu Fifth People's Hospital

Chengdu, Sichuan, 611130, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Zhu Xianyi Memorial Hospital

Tianjin, Tianjin Municipality, 300070, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Location

INTENDIA klinika s.r.o.

Chrudim III, Chrudim, 537 01, Czechia

Location

MUDr. Alena Vachova

České Budějovice, Jihočeský kraj, 37011, Czechia

Location

MUDr. Tomas Edelsberger

Krnov, Moravskoslezský kraj, 79401, Czechia

Location

Diahelp s.r.o

Pardubice V, Pardubice, 530 02, Czechia

Location

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, Praha 4, 14900, Czechia

Location

Diacentrum Brandys n.L. s.r.o.

Brandýs nad Labem, Praha-vých, 25001, Czechia

Location

MUDr. Tomas Hrdina

Opočno, Rychnov Nad Kněžnou, 517 73, Czechia

Location

Praxis Sauter & Sauter & Vorbach

Wangen, Baden-Wurttemberg, 88239, Germany

Location

InnoDiab Forschung Gmbh

Essen, North Rhine-Westphalia, 45136, Germany

Location

Medizentrum Essen Borbeck

Essen, North Rhine-Westphalia, 45355, Germany

Location

Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany

Location

Zentrum für klinische Studien

Saint Ingbert, Saarland, 66386, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

Location

RED-Institut GmbH

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

Location

Diabeteszentrum Hamburg West

Hamburg, 22607, Germany

Location

Iatriko Paleou Falirou Medical Center

Palaió Fáliro, Attikí (Region), 17562, Greece

Location

Alexandra Hospital

Athens, Attikí, 11528, Greece

Location

Thermi Clinic

Thessaloniki, Thessaloníki, 570 01, Greece

Location

Athens Euroclinic

Athens, 115 21, Greece

Location

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, Aichi-ken, 468-0009, Japan

Location

Kashiwa City Hospital

Kashiwa, Chiba, 277-0825, Japan

Location

Tokuyama Clinic

Mihama-ku,Chiba City, Chiba, 261-0004, Japan

Location

Nippon Kokan Fukuyama Hospital

Fukuyama-shi, Hiroshima, 721-0927, Japan

Location

Hasegawa Medical Clinic

Chitose, Hokkaido, 066-0032, 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

Hayashi Diabetes Internal Medicine Clinic

Chigasaki, Kanagawa, 253-0044, Japan

Location

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Shimizu Clinic Fusa

Saitama-shi, Saitama, 336-0967, Japan

Location

Kumanomae Nishimura Clinic

Arakawa-ku, Tokyo, 116-0012, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Hachioji Diabetes Clinic

Hachioji-shi, Tokyo, 192-0083, Japan

Location

Medical Corporation Sato Medical clinic

Ootaku, Tokyo, 143-0015, Japan

Location

Tomonaga Clinic

Shinjuku, Tokyo, 160-0022, Japan

Location

Yoshimura Clinic

Kumamoto, 861-8039, Japan

Location

Abe Clinic

Ōita, 870-0039, Japan

Location

Investigacion En Salud Y Metabolismo Sc

Chihuahua City, 31217, Mexico

Location

Centro de Endocrinologia y Nutricion

Caguas, 00725, Puerto Rico

Location

Private Practice - Dr. Paola Mansilla-Letelier

Guaynabo, 00970, Puerto Rico

Location

Kangwon National University Hospital

Chuncheon, Kang-won-do, 24289, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Kyǒnggi-do, 11923, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teuk, 03722, South Korea

Location

Related Publications (2)

• Miller E, Davidson MB, Bajaj HS, Rosenstock J, Philis-Tsimikis A, Bergenstal RM, Case M, Ilag L, Threlkeld R, Levasseur E, Gelsey F. Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program. Diabetes Ther. 2026 Jan 27. doi: 10.1007/s13300-025-01833-5. Online ahead of print.

  PMID: 41591636 DERIVED

• Wysham C, Bajaj HS, Del Prato S, Franco DR, Kiyosue A, Dahl D, Zhou C, Carr MC, Case M, Firmino Goncalves L; QWINT-2 Investigators. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2024 Dec 12;391(23):2201-2211. doi: 10.1056/NEJMoa2403953. Epub 2024 Sep 10.

  PMID: 39254740 DERIVED

Related Links

• A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

As prespecified in the statistical analysis plan, outcome analyses related to Continuous Glucose Monitoring (CGM) were conducted using data from the Dexcom G6 system, which was used at all study sites except those in China. In China, CGM data were collected using the Libre FreeStyle H system.

Results Point of Contact

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

ClinicalTrials.gov@lilly.com

800-545-5979

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 DIRECTOR

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: May 2, 2022
• First Posted: May 5, 2022
• Study Start: June 3, 2022
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

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 European Union (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

GR (4); JP (18); ME (1); US (30); PR (2); CN (26); CZ (7); KR (3); BR (7); CA (7); DE (8)