A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

April 15, 2024 updated by: Eli Lilly and Company

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

692

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 Locations

  • Argentina
      • Buenos Aires, Argentina, 1405
        • Instituto Médico Especializado (IME)
      • Córdoba, Argentina, 5000
        • Centro Diabetológico Dr. Waitman
    • Buenos Air
      • Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina, C1405BUB
        • Consultorio de Investigación Clínica EMO SRL
      • Moron, Buenos Air, Argentina, B1708EPE
        • CIAD Moron
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1060ABN
        • CEDIC
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
        • Centro de Investigaciones Metabólicas (CINME)
    • Ciudad Autónoma De Buenos Aire
      • Balvanera, Ciudad Autónoma De Buenos Aire, Argentina, C1056ABH
        • Investigaciones Medicas Imoba Srl
      • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1128AAF
        • Mautalen Salud e Investigación
    • Córdoba
      • Capital, Córdoba, Argentina, X5008HHW
        • Centro Medico Privado CEMAIC
      • Cordoba, Córdoba, Argentina, 5006
        • Centro Medico Privado San Vicente Diabetes
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Centro de Salud e Investigaciones Médicas
    • Mendoza
      • Godoy Cruz, Mendoza, Argentina, M5501ARP
        • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
      • San Miguel de Tucuman, Tucumán, Argentina, 4000
        • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
  • Japan
      • Fukuoka, Japan, 815-0071
        • Clinic Masae Minami
      • Miyazaki, Japan, 880-0034
        • Heiwadai Hospital
      • Oita, Japan, 870-0039
        • Abe Clinic
    • Aichi
      • Nagoya-shi, Aichi, Japan, 468-0009
        • Tosaki Clinic for Diabetes and Endocrinology
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0062
        • Manda Memorial Hospital
    • Ibaraki
      • Mito, Ibaraki, Japan, 311-4153
        • MinamiAkatsukaClinic
      • Naka, Ibaraki, Japan, 311-0113
        • Nakakinen clinic
      • Ushiku, Ibaraki, Japan, 300-1207
        • Noritake Clinic
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Takai Internal Medicine Clinic
    • Saitama
      • Saitama-shi, Saitama, Japan, 336-0967
        • Shimizu Clinic Fusa
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0002
        • The Institute for Adult Disease, Asahi Life Foundation
      • Hachioji-shi, Tokyo, Japan, 192-0083
        • Hachioji Diabetes Clinic
  • Poland
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-333
        • Gabinety TERPA
      • Lublin, Lubelskie, Poland, 20-538
        • NZOZ Medica
    • Mazowiecki
      • Warszawa, Mazowiecki, Poland, 00-710
        • NBR Polska
    • Mazowieckie
      • Radom, Mazowieckie, Poland, 26-600
        • Centrum Medyczne "Diabetika"
      • Warszawa, Mazowieckie, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-261
        • NZOZ Diab-Endo-Met
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-404
        • SN ZOZ Lege Artis Poradnia Diabetologiczna
      • Bialystok, Podlaskie, Poland, 15-435
        • NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Śląskie
      • Zabrze, Śląskie, Poland, 41-800
        • Private Practice - Dr. Janusz Gumprecht
  • Puerto Rico
      • Bayamon, Puerto Rico, 00959
        • Advanced Clinical Research, LLC
      • San Juan, Puerto Rico, 921
        • Endocrinologist Metabolic Clinic & Research Institute
  • Slovakia
    • Košický Kraj
      • Rožňava, Košický Kraj, Slovakia, 04801
        • Tatratrial s.r.o.
    • Nitriansky Kraj
      • Nove Zamky, Nitriansky Kraj, Slovakia, 940 01
        • Funkystuff s.r.o.
    • Žilinský Kraj
      • Dolny Kubin, Žilinský Kraj, Slovakia, 026 01
        • ENDIAMED s.r.o
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Changhua Christian Hospital
    • Taichung
      • Taichung City, Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taichung City, Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
    • Tainan
      • Tainan City, Tainan, Taiwan, 71004
        • Chi Mei Medical Center
    • Taipei
      • Taipei City, Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network Research Center
      • Fresno, California, United States, 93720
        • Valley Research
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute (NERI)
      • Fort Lauderdale, Florida, United States, 33312
        • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
      • Port Charlotte, Florida, United States, 33952
        • Hanson Clinical Research Center
    • Georgia
      • Macon, Georgia, United States, 31210
        • East Coast Institute for Research at The Jones Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
      • Rockville, Maryland, United States, 20852
        • Endocrine and Metabolic Consultants
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Sunset
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
    • New York
      • Buffalo, New York, United States, 14221
        • Research Foundation of SUNY - University of Buffalo
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10016
        • NYC Research
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Dallas, Texas, United States, 75231
        • Research Institute of Dallas
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Houston, Texas, United States, 77089
        • Amir A Hassan, MD, PA
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

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 clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
  • Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
  • Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
  • Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria:

  • Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
  • Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
  • Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

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 Degludec
Participants will receive insulin degludec SC
Drug: Insulin Degludec
Administered SC
Experimental: Insulin Efsitora Alfa
Participants will receive insulin efsitora alfa by subcutaneously (SC)
Drug: Insulin Efsitora Alfa
Administered SC
Other Names:
  • LY3209590 and Basal Insulin-FC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 26
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basal Insulin Dose
Time Frame: Week 26
Week 26
Bolus Insulin Dose
Time Frame: Week 26
Week 26
Total Insulin Dose
Time Frame: Week 26
Week 26
Change from Baseline in Body Weight
Time Frame: Baseline, Week 26
Baseline, Week 26
Time in Glucose Range
Time Frame: Week 22 to Week 26
Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26
Week 22 to Week 26
Nocturnal Hypoglycemia Event Rate
Time Frame: Baseline to Week 52
The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52.
Baseline to Week 52
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 26
Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).
Baseline, Week 26
Glucose Variability
Time Frame: Week 22 to Week 26
Glucose variability measured by CGM 4 weeks prior to week 26
Week 22 to Week 26
Rate of Composite Level 2 and 3 Hypoglycemia Events
Time Frame: Baseline to Week 52
Baseline to Week 52
Time in Hypoglycemia Range
Time Frame: Week 22 to Week 26
Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL, measured by CGM 4 weeks prior to week 26.
Week 22 to Week 26
Time in Hyperglycemia Range
Time Frame: Week 22 to Week 26
Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.
Week 22 to Week 26
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Time Frame: Baseline, Week 26
DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Baseline, Week 26
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores
Time Frame: Baseline, Week 26
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Baseline, Week 26

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Investigators

  • Study Chair: 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)

August 12, 2022

Primary Completion (Estimated)

May 6, 2024

Study Completion (Estimated)

May 6, 2024

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18263
  • I8H-MC-BDCY (Other Identifier: Eli Lilly and Company)
  • 2021-005892-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant 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 US and 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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