A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) (QWINT-1)

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes

The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; T2D
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin Efsitora Alfa

• Study Type: Interventional
• Enrollment (Actual): 795
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Ciudad Autónoma de Buenos Aire, Argentina, C1440AAD
    • CENUDIAB
  • Santa Fe, Argentina, 3000
    • Centro de Diagnóstico y Rehabilitación (CEDIR)
  • Santiago del Estero, Argentina, 4200
    • Sanatorio Norte
  • Buenos Air
    • Buenos Aires, Buenos Air, Argentina, C1419AHN
      • Asociacion de Beneficencia Hospital Sirio Libanes
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
      • Centro de Investigaciones Metabólicas (CINME)
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Instituto de Investigaciones Clinicas Mar del Plata
    • Ramos Mejía, Buenos Aires, Argentina, 1704
      • DIM Clinica Privada
    • San Nicolas, Buenos Aires, Argentina, 2900
      • Go Centro Medico San Nicolás
  • Ciudad Aut
    • Buenos Aires, Ciudad Aut, Argentina, C1120AAC
      • Centro Médico Viamonte
    • Buenos Aires, Ciudad Aut, Argentina, C1430CKE
      • Glenny Corp
    • Buenos Aires, Ciudad Aut, Argentina, C1023AAB
      • Stat Research S.A.
    • C.a.b.a., Ciudad Aut, Argentina, C1205AAO
      • CEMEDIAB
  • Ciudad Autónoma De Buenos Aire
    • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1061AAS
      • CIPREC
    • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1056ABH
      • Investigaciones Medicas IMOBA SRL
    • Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, Argentina, C1425AGC
      • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Córdoba
    • Cordoba, Córdoba, Argentina, 5006
      • Centro Medico Privado San Vicente Diabetes
    • Río Cuarto, Córdoba, Argentina, 5800
      • Instituto Medico Rio Cuarto
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
  • Tucumán
    • San Miguel de Tucuman, Tucumán, Argentina, 4000
      • Clinica Mayo
• Mexico
  • Chihuahua, Mexico, 31217
    • Investigacion En Salud Y Metabolismo Sc
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 03100
      • RM Pharma Specialists
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Diseno y Planeacion en Investigacion Medica
    • Guadalajara, Jalisco, Mexico, 04460
      • Instituto Jalisciense de Investigacion en Diabetes y Obesidad
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62250
      • Instituto de Diabetes, Obesidad y Nutricion
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • San Nicolás de los Garza, Nuevo León, Mexico, 66465
      • Unidad Médica para la Salud Integral
  • Yucatán
    • Merida, Yucatán, Mexico, 97070
      • Medical Care and Research SA de CV
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc.
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants LLC
  • California
    • Escondido, California, United States, 92025
      • AMCR Institute
    • Gardena, California, United States, 90247
      • Velocity Clinical Research, Gardena
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park
    • Los Angeles, California, United States, 90057
      • National Research Institute - Wilshire
    • Orange, California, United States, 92868
      • Diabetes Associates Medical Group
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Thousand Oaks, California, United States, 93065
      • Millennium Clinical Trials
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Pacific Diabetes & Endocrine Center
  • Illinois
    • Springfield, Illinois, United States, 62711
      • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
  • Indiana
    • Franklin, Indiana, United States, 46131
      • American Health Network of Indiana, LLC - Franklin
    • Muncie, Indiana, United States, 47304
      • American Health Network of Indiana, LLC - Muncie
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68198-4130
      • University of Nebraska Medical Center
  • New York
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research
    • Vestal, New York, United States, 13850
      • Meridian Clinical Research, LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Feasterville-Trevose, Pennsylvania, United States, 19053
      • Decpa, Llc
    • Pittsburgh, Pennsylvania, United States, 15236
      • Office 18
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Private Practice - Dr. Osvaldo A. Brusco
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Flower Mound, Texas, United States, 75028
      • Prime Revival Research Institute
    • Houston, Texas, United States, 77079
      • Endocrine Ips, Pllc
    • Houston, Texas, United States, 77004
      • Endocrine Associates
    • North Richland Hills, Texas, United States, 76180
      • North Hills Family Medicine/North Hills Medical Research
    • Weslaco, Texas, United States, 78596
      • Texas Valley Clinical Research
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a diagnosis of T2D according to the World Health Organization criteria.
• Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
• Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
• Are insulin naive

Exceptions:

• short-term insulin treatment for a maximum of 14 days, prior to screening, and
• prior insulin treatment for gestational diabetes.

Exclusion Criteria:

• Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or 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 >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 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, ≥5%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Efsitora Alfa; Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.	Drug: Insulin Efsitora Alfa; Administered SC; Other Names: LY3209590 and Basal Insulin-FC
Active Comparator: Insulin Glargine; Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.	Drug: Insulin Glargine; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]	HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c [Superiority]	HbA1c is the glycated 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 + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.	Baseline, Week 52
Change From Baseline in Fasting Glucose	Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).	Baseline, Week 52
Basal Insulin Dose at Week 52	The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Week 52
Rate Per Year of Hypoglycemia Events	Rate of Composite Level 2 and 3 Hypoglycemia Events were reported. Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (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 model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.	Baseline up to Week 52
Percentage of Participants With Hypoglycemia Events (Incidence)	Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia with glucose <54 mg/dL (Level 2) or severe hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3). 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.	Week 52
Rate Per Year of Nocturnal Hypoglycemia Events	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 52. 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.	Baseline up to Week 52
Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence)	Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. 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 52..	Week 52
Change From Baseline in Body Weight	Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).	Baseline, Week 52
Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score	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. The TRIM-D questionnaire consists of 5 sub-domains. Treatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + Treatment + Time + Treatment*Time(Type III sum of squares) as variables.	Baseline, Week 52
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)	The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception. This outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18.	Baseline, Week 52
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version	The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants: "How simple or complex is your medication treatment for diabetes?"; "Overall, how simple or complex is it to manage your diabetes, including medication, checking your blood glucose levels, diet, and any other aspects of diabetes treatment?" Participants were asked to provide responses to the study intervention at Week 52. Each item is scored on a 5-point scale ranging from "Very complex" to "Very simple." Higher scores indicate a more favorable (simpler) treatment experience.	Week 52
Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics	DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as: Ease of preparation; Comfort during injection; Portability; Discreetness; Confidence in dose delivery; Ease of learning to use; Satisfaction with device features Each item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device. LS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 52
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)	The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems. This outcome measure specifically reports the summary of DID-EQ scores for the 3 global items: Item 8: Overall satisfaction with the injection device; Item 9: Ease of use of the injection device; Item 10: Convenience of the injection device Each item is rated on a 4-point Likert scale: Strongly Disagree; Disagree; Agree; Strongly Agree Responses are transformed to a 0-100 scale, where: 0 = Most negative perception; 100 = Most positive perception Higher scores indicate more favorable perceptions of the injection device's global characteristics.	Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

• A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2023
• Primary Completion (Actual): July 19, 2024
• Study Completion (Actual): July 19, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin Glargine; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 18261; I8H-MC-BDCW (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the United States (US) and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No