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AzTrials

Type 2 DiabetesPhase 3NCT05275400

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

A Phase 3 study testing Insulin Efsitora Alfa and Insulin Degludec in people with Type 2 Diabetes, run by Eli Lilly and Company at 127 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Insulin Efsitora Alfa and Insulin Degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
986 participants
Where
127 sitesin 10 countries
Study dates
8 Mar 2022to 15 May 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

127 sites in 10 countries.

127 sites in 10 countries

United States38 sites

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York, 12203

  • Gadolin Research

    Beaumont, Texas, 77702

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • John Muir Physician Network Research Center

    Concord, California, 94520

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • AMCR Institute

    Escondido, California, 92025

  • Lillestol Research

    Fargo, North Dakota, 58104

  • SKY Clinical Research Network Group - Hall

    Fayette, Mississippi, 39069

  • Encore Medical Research

    Hollywood, Florida, 33021

  • Juno Research

    Houston, Texas, 77040

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia, 30046

  • Medical Investigations

    Little Rock, Arkansas, 72211

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • New Horizon Research Center

    Miami, Florida, 33165

  • HealthPartners Institute dba International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • NYC Research

    New York, New York, 10016

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Diabetes Associates Medical Group

    Orange, California, 92868

  • Jefferson Clinical Research Institute (JCRI)

    Philadelphia, Pennsylvania, 19114

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

Japan20 sites

  • Tokyo-Eki Center-building Clinic

    Chuo Ku, Tokyo, 103-0027

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0028

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Matoba Internal Medicine Clinic

    Ebina, Kanagawa, 243-0432

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056

  • Shiraiwa Medical Clinic

    Kashihara, Osaka, 582-0005

  • Jinnouchi Hospital

    Kumamoto, 862-0976

  • Tokuyama Clinic

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

  • Nakamoto Internal Medicine Clinic

    Mito, Ibaraki, 310-0826

  • Kozawa Eye Hospital and Diabetes Center

    Mito, Ibaraki, 310-0845

  • Heiwadai Hospital

    Miyazaki, 880-0034

  • Abe Clinic

    Ōita, 870-0039

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Oyama East Clinic

    Oyama, Tochigi, 323-0022

  • Shimizu Clinic Fusa

    Saitama-shi, Saitama, 336-0967

  • Yuri Ono Clinic

    Sapporo, Hokkaido, 060-0001

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka, 569-1045

  • Noritake Clinic

    Ushiku, Ibaraki, 300-1207

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004

Other trials in Japan

Argentina14 sites

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Aut, C1120AAC

  • Mautalen Salud e Investigación

    Buenos Aires, Ciudad Aut, C1128AAF

  • CEMEDIC

    Buenos Aires, 1407

  • Instituto Centenario

    CABA, Ciudad Autónoma de Buenos Aire, 1204

  • Centro Medico Privado CEMAIC

    Capital, Córdoba Province, X5008HHW

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056

  • Stat Research S.A.

    Ciudad Autónoma de Buenos Aire, Buenos Air, C1023AAB

  • CENUDIAB

    Ciudad Autónoma de Buenos Aire, C1440AAD

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, Mendoza Province, M5501ARP

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Instituto Médico Catamarca IMEC

    Rosario, Santa Fe Province, 2000

  • Go Centro Medico San Nicolás

    San Nicolás de los Arroyos, Buenos Aires, 2900

Other trials in Argentina

South Korea12 sites

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do, 15355

  • Kangwon National University Hospital

    Chuncheon, Kang-won-do, 24289

  • Hanyang University Guri Hospital

    Guri-si, Kyǒnggi-do, 11923

  • Yeungnam Univeristy Medical Center

    Gyeongsan-si, Kyǒngsangbuk-do, 42415

  • Inje University Sanggye Paik Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 01757

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 07441

  • Kyung Hee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi [Seoul], 134-090

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teuk, 03722

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033

  • Yonsei University-Wonju Severance Christian Hospital

    Wŏnju, Kang-won-do, 26426

Other trials in South Korea

Poland11 sites

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • NZOZ Diab-Endo-Met

    Krakow, Lesser Poland Voivodeship, 31-261

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

    Lodz, Łódź Voivodeship, 90338

  • CenterMed Lublin NZOZ

    Lublin, Lublin Voivodeship, 20-044

  • Gabinety TERPA

    Lublin, Lublin Voivodeship, 20-333

  • NZOZ Medica

    Lublin, Lublin Voivodeship, 20-538

  • IRMED

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300

  • OMEDICA Medical Center

    Poznan, Greater Poland Voivodeship, 60-111

  • Gaja Poradnie Lekarskie Maciej Wiza

    Poznan, Greater Poland Voivodeship, 61-251

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

    Ruda Śląska, Silesian Voivodeship, 41-709

  • Private Practice - Dr. Robert Witek

    Tarnów, Lesser Poland Voivodeship, 33-100

Other trials in Poland

Spain11 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña], 15006

  • Centro Periférico de Especialidades Bola Azul

    Almería, Almería, 04009

  • Hospital Universitario de La Ribera

    Alzira, Valenciana, Comunitat, 46600

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Clínica Juaneda

    Palma de Mallorca, Balears [Baleares], 07014

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Quiron Infanta Luisa

    Seville, Andalusia, 41010

  • Vithas Hospital Sevilla

    Seville, Sevilla, 41950

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital General Universitario de Valencia

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Slovakia7 sites

  • Diacrin .s.ro.

    Bratislava, 84102

  • ENDIAMED s.r.o

    Dolný Kubín, Žilina Region, 026 01

  • Human Care s.r.o.

    Košice, Košice Region, 04012

  • MediVet s.r.o.

    Malacky, Bratislava Region, 901 01

  • DIA-MED CENTRUM s.r.o.

    Púchov, 020 01

  • MEDI-DIA s.r.o.

    Sabinov, Presov, 083 01

  • Areteus s.r.o.

    Trebišov, Košice Region, 075 01

Other trials in Slovakia

Hungary6 sites

  • DRC Gyógyszervizsgáló Központ

    Balatonfüred, Veszprém megye, 8230

  • Szent Margit Rendelointézet

    Budapest, 1032

  • Szent János Kórház

    Budapest, 1125

  • Strazsahegy Medicina Bt.

    Budapest, H1171

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala County, 8800

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Taiwan6 sites

  • Fu Jen Catholic University Hospital

    New Taipei City, 24352

  • Chung Shan Medical University Hospital

    Taichung, Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, Taichung, 407

  • Chi Mei Medical Center

    Tainan, Tainan, 71004

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Puerto Rico2 sites

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917

  • Mgcendo Llc

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)

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
Being tested
Insulin Efsitora Alfa, Insulin Degludec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Efsitora AlfaDrug

    Also called LY3209590 and Basal Insulin-FC

    Administered SC

  • Insulin DegludecDrug

    Administered SC

Study groups in NCT05275400
Study groupRoleWhat they receive
500 U/mL - Insulin EfsitoraExperimentalParticipants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
Receives: Drug: Insulin Efsitora Alfa
100 U/mL - Insulin DegludecActive comparatorParticipants received 100 U/mL insulin degludec administered SC once daily (QD).
Receives: Drug: Insulin Degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.

    Measured: Baseline, Week 26

Secondary outcomes (13)

  1. Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.

    Measured: Baseline, Week 26

  2. Nocturnal Hypoglycemia Event Rate

    The event rate of participant-reported clinically significant glucose <54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.

    Measured: Baseline up to Week 78

  3. Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L)

    Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach.

    Measured: Week 22 to Week 26

  4. Change From Baseline in Fasting Glucose

    Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach.

    Measured: Baseline, Week 26

  5. Weekly Insulin Dose at Week 26

    The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.

    Measured: Week 26

  6. Hypoglycemia Event Rate

    Patient reported events of hypoglycemia - Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.

    Measured: Baseline up to Week 78

  7. Change From Baseline in Body Weight

    Change from baseline in body weight was reported. LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

    Measured: Baseline, Week 78

  8. Percentage of Time in Hypoglycemia Range

    Percentage of time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach.

    Measured: Week 22 to Week 26

  9. Percentage of Time in Hyperglycemia Range

    Percentage of time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach.

    Measured: Week 22 to Week 26

  10. Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)

    The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact:

    • Treatment Burden (6 items)
    • Daily Life (5 items)
    • Diabetes Management (5 items)
    • Compliance (4 items), and
    • Psychological Health (8 items)

    Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant's functioning and well-being.

    LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

    Measured: Baseline, Week 26, Week 52, Week 78

  11. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26

    DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.

    Measured: Week 26

  12. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52

    DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.

    Measured: Week 52

  13. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78

    DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.

    Measured: Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start8 Mar 2022
  3. Primary completion15 May 2024
  4. Study completion15 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
986 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05275400
Sponsor's protocol ID
18237
Other IDs
I8H-MC-BDCU, 2021-002569-16
Status last verified
May 2025
First submitted
3 Mar 2022
Last updated
3 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Philis-Tsimikas A, Galindo RJ, Guerci B, Threlkeld RJ, Mushala B, Shyam CP, Goldyn A. Hospitalization outcomes in adults with type 2 diabetes mellitus treated with once-weekly insulin efsitora versus once-daily basal insulins: A post hoc analysis of the QWINT-1 to -4 randomized trials. Diabetes Res Clin Pract. 2026 Oct 3:113586. doi: 10.1016/j.diabres.2026.113586. Online ahead of print.

    PubMed 42829184

  • Jinnouchi H, Inoue M, Takita Y, Nasu R, Threlkeld R. Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Using Basal Insulin: QWINT-3 Japan Subgroup Analysis. Diabetes Ther. 2026 Aug 7. doi: 10.1007/s13300-026-01902-3. Online ahead of print.

    PubMed 42565976

  • 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 Mar;17(3):431-447. doi: 10.1007/s13300-025-01833-5. Epub 2026 Jan 27.

    PubMed 41591636

  • 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.

    PubMed 40562047

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Efsitora Alfa and Insulin Degludec in people with Type 2 Diabetes, run by Eli Lilly and Company at 127 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Japan, Argentina, South Korea, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority] (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05275400, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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