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Type 2 DiabetesPhase 3QWINT-4NCT05462756

A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections

A Phase 3 study testing Insulin Efsitora Alfa, Insulin Lispro (U100) and Insulin Glargine (U100) in people with Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, run by Eli Lilly and Company at 81 sites in 8 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 evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Insulin Efsitora Alfa, Insulin Lispro (U100) and Insulin Glargine (U100)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
730 participants
Where
81 sitesin 8 countries
Study dates
11 Aug 2022to 27 Feb 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 a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
  • Are receiving ≥10 units of total basal insulin per day at screening.
  • Are receiving ≤2 units/kilogram/day of total daily insulin at screening
  • Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
  • Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
  • once daily U-100 or U-200 insulin degludec
Show all 21Show fewer
  • once daily U-100 or U-300 insulin glargine
  • once or twice daily U-100 insulin detemir or
  • once or twice daily human insulin Neutral Protamine Hagedorn
  • Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
  • Insulin lispro-aabc
  • Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
  • Insulin aspart (U-100)
  • Insulin glulisine (U-100), or
  • Regular insulin (U-100)
  • Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
  • dipeptidyl peptidase IV inhibitors
  • sodium-glucose co-transporter-2 inhibitors
  • biguanides (for example, metformin), or
  • glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
  • Have a body mass index ≤45 kilogram/square meter (kg/m²)

Who cannot join

  • Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
  • Are currently receiving any of the following insulin therapies anytime in the past 90 days:
  • insulin mixtures
  • insulin human, inhalation powder, or
  • continuous subcutaneous insulin infusion therapy, or
  • regular insulin U-500
Show all 12Show fewer
  • Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
  • Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
  • Have hypoglycemia unawareness in the opinion of the investigator
  • Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
  • Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
  • Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening

Trial locations and contacts

81 sites in 8 countries.

81 sites in 8 countries

United States24 sites

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78749

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Heritage Valley Multispecialty Group, Inc

    Beaver, Pennsylvania, 15009

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York, 14221

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Remington Davis Clinical Research

    Columbus, Ohio, 43215

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Aventiv Research

    Dublin, Ohio, 43016

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Research Institute of Dallas

    Plano, Texas, 75093

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • Encore Medical Research - Weston

    Weston, Florida, 33331

Other trials in United States

Argentina16 sites

  • Mautalen Salud e Investigación

    Buenos Aires, Buenos Aires F.D., C1128AAF

  • CENUDIAB

    Buenos Aires, C1440AAD

  • CEDIC

    CABA, Buenos Aires, C1060ABN

  • CIPREC

    CABA, Buenos Aires F.D., C1061AAS

  • Instituto Centenario

    CABA, Ciudad Autónoma de Buenos Aire, 1204

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1425AGC

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, 5800

  • Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta

    Rosario, Santa Fe Province, 2000

  • Instituto Médico Catamarca IMEC

    Rosario, Santa Fe Province, 2000

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Go Centro Medico San Nicolás

    San Nicolás de los Arroyos, Buenos Aires, 2900

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, 3000

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Spain12 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña], 15006

  • Hospital Universitario de La Ribera

    Alzira, Valenciana, Comunitat, 46600

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [Cataluña], 08041

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, A Coruña [La Coruña], 15405

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Universitari Son Espases

    Palma, Balears [Baleares], 07120

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • 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

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Castille and León, 47010

Other trials in Spain

Italy8 sites

  • INRCA Ancona

    Ancona, 60125

  • IRCCS - AOU di Bologna

    Bologna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera Mater Domini

    Catanzaro, 88100

  • Osepdale Civile Fr 5

    Ceccano, Frosinone, 03023

  • Ospedale san Giovanni di Dio-Diabetologia

    Olbia, Sardinia, 07026

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, 90127

  • "Fatebenefratelli Isola Tiberina - Gemelli Isola"

    Rome, Lazio, 00186

Other trials in Italy

Germany7 sites

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136

  • ClinPhenomics GmbH & Co KG

    Frankfurt am Main, Hesse, 60596

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • Institut für Diabetesforschung GmbH Münster

    Münster, North Rhine-Westphalia, 48145

  • Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage

    Münster, North Rhine-Westphalia, 48153

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

Other trials in Germany

India6 sites

  • Life Care Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • Post Graduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, 160012

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

    Mumbai, Maharashtra, 400008

  • BSES MG Hospital

    Mumbai, Maharashtra, 400058

Other trials in India

Mexico6 sites

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua City, 31217

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

    Ciudad Madero, Tamaulipas, 89440

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco, 44670

  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco, 44670

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

Puerto Rico2 sites

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamón, 00959

  • Manati Center for Clinical Research

    Manati, 00674

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections

The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.

Being tested
Insulin Efsitora Alfa, Insulin Lispro (U100), Insulin Glargine (U100)
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 Lispro (U100)Drug

    Also called Humalog

    Administered SC

  • Insulin Glargine (U100)Drug

    Also called Basaglar

    Administered SC

Study groups in NCT05462756
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) along with 100 U/mL insulin lispro given SC with meals as needed.
Receives: Drug: Insulin Efsitora Alfa; Drug: Insulin Lispro (U100)
100 U/mL - Insulin GlargineActive comparatorParticipants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed.
Receives: Drug: Insulin Lispro (U100); Drug: Insulin Glargine (U100)

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.

    Measured: Baseline, Week 26

Secondary outcomes (15)

  1. Change From Baseline in HbA1c [Superiority]

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Measured: Baseline, Week 26

  2. Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia

    Percentage of participants achieving HbA1c <7% without nocturnal hypoglycemia [<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L)] or severe during treatment phase up to week 26. Nocturnal hypoglycemia is a hypoglycemia event, including severe hypoglycemia, that occurs at night and presumably during sleep between midnight and 6:00 am.

    Measured: Week 26

  3. Nocturnal Hypoglycemia Event Rate

    The event rate of participant-reported clinically significant nocturnal hypoglycemia, (where glucose <54 mg/dL (3.0 mmol/L) or severe and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 26. Group mean is reported here.

    Measured: Baseline Up To Week 26

  4. Change From Baseline in Fasting Glucose

    Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG).

    Measured: Baseline, Week 26

  5. Percentage of Time in Glucose Range

    Percentage of Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session.

    Measured: Week 22 to Week 26

  6. Percentage of Time in Hypoglycemia Range

    Percentage of Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L), measured by CGM.

    Measured: Week 22 to Week 26

  7. Percentage of Time in Hyperglycemia Range

    Percentage of Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L), measured by CGM.

    Measured: Week 22 to Week 26

  8. Glucose Variability Between Weeks 22 to 26

    Glucose variability measured as coefficient of variation for glucose within day for 24-hour period between Week 22 and 26 was reported.

    Measured: Week 22 to Week 26

  9. Basal Insulin Dose at Week 26

    Average weekly basal Insulin Dose at Week 26 was reported.

    Measured: Week 26

  10. Bolus Insulin Dose at Week 26

    Average daily bolus Insulin Dose at Week 26 was reported.

    Measured: Week 26

  11. Total Insulin Dose at Week 26

    Average total weekly insulin dose at Week 26 was reported.

    Measured: Week 26

  12. Basal Insulin Dose to Total Insulin Dose Ratio at Week 26

    Basal insulin dose to total insulin dose ratio at Week 26 was reported.

    Measured: Week 26

  13. Hypoglycemia Event Rate

    Hypoglycemia event rate was reported. 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 here.

    Measured: Baseline up to Week 26

  14. Change From Baseline in Body Weight

    Change from baseline in body weight was reported.

    Measured: Baseline, Week 26

  15. Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)

    The DID-EQ is a self-administered, 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for diabetes. The Device Characteristic Subscale is comprised of items 1 to 7 which focus on specific characteristics of injection devices. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics

    Measured: Week 26

Timeline

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

  1. First posted18 Jul 2022
  2. Study start11 Aug 2022
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 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
730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05462756
Sponsor's protocol ID
18260
Other IDs
I8H-MC-BDCV, 2021-005878-25
Acronym
QWINT-4
Status last verified
Apr 2025
First submitted
14 Jul 2022
Last updated
27 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

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

  • 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

  • Blevins T, Dahl D, Perez Manghi FC, Murthy S, Ortiz Carrasquillo R, Li X, Chang AM, Carr MC, Katz M. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2290-2301. doi: 10.1016/S0140-6736(25)01069-4. Epub 2025 Jun 22.

    PubMed 40562048

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Efsitora Alfa, Insulin Lispro (U100) and Insulin Glargine (U100) in people with Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, run by Eli Lilly and Company at 81 sites in 8 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 21 inclusion and 12 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Argentina, Spain, Italy, Germany and 3 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 27 Apr 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 NCT05462756, which also lists 3 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 27 Apr 2025.

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