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)

April 17, 2024 updated by: Eli Lilly and Company

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

796

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@Lilly.com

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
        • Asociación de Beneficencia Hospital Sirio Libanés
    • 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 Clínicas Mar del Plata
      • Ramos Mejía, Buenos Aires, Argentina, 1704
        • DIM Clínica 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 Médico Privado San Vicente Diabetes
      • Río Cuarto, Córdoba, Argentina, X5800AEV
        • Instituto Médico Río 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
        • Clínica 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, 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
      • 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, 91360
        • 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
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin Glargine
Participants will receive insulin glargine SC once daily.
Drug: Insulin Glargine
Administered SC
Experimental: Insulin Efsitora Alfa
Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
Drug: Insulin Efsitora Alfa
Administered SC
Other Names:
  • LY3209590 and Basal Insulin-FC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 52
Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 52
Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)
Baseline, Week 52
Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence
Time Frame: Week 52
Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Week 52
Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence
Time Frame: Week 52
Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Week 52
Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction
Time Frame: Baseline, Week 52
DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Baseline, Week 52
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Time Frame: Baseline, Week 52
TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments.
Baseline, Week 52
Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity
Time Frame: Baseline, Week 52
SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication).
Baseline, Week 52
Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics
Time Frame: Baseline, Week 52
DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes.
Baseline, Week 52
Change from Baseline in HbA1c
Time Frame: Baseline, Week 52
Demonstrate superiority of insulin efsitora alfa compared to insulin glargine
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2023

Primary Completion (Estimated)

July 16, 2024

Study Completion (Estimated)

July 16, 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)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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