Clinical trial NCT05662332: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
T2D
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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%.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change from Baseline in HbA1c
timeFrame: Baseline, Week 52
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 52
measure: Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence
timeFrame: Week 52
measure: Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence
timeFrame: Week 52
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction
timeFrame: Baseline, Week 52
measure: Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
timeFrame: Baseline, Week 52
measure: Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity
timeFrame: Baseline, Week 52
measure: Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research
state: Alabama
city: Sheffield
country: United States
facility: Syed Research Consultants Llc
state: Alabama
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Gardena
country: United States
facility: Velocity Clinical Research, Gardena
state: California
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Orange
country: United States
facility: Diabetes Associates Medical Group
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Springfield
country: United States
facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
state: Illinois
city: Franklin
country: United States
facility: American Health Network of Indiana, LLC - Franklin
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC - Muncie
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Feasterville-Trevose
country: United States
facility: Decpa, Llc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Office 18
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Corpus Christi
country: United States
facility: Private Practice - Dr. Osvaldo A. Brusco
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Flower Mound
country: United States
facility: Prime Revival Research Institute
state: Texas
city: Houston
country: United States
facility: Endocrine Associates
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Medicine/North Hills Medical Research
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Stat Research S.A.
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Glenny Corp
state: Ciudad Aut
city: C.a.b.a.
country: Argentina
facility: CEMEDIAB
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aire
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aire
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aire
city: Cordoba
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
state: Córdoba
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Godoy Cruz
country: Argentina
facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
state: Mendoza
city: Rosario
country: Argentina
facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clínica Mayo
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: CENUDIAB
city: Santa Fe
country: Argentina
facility: Centro de Diagnóstico y Rehabilitación (CEDIR)
city: Santiago del Estero
country: Argentina
facility: Sanatorio Norte
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad
state: Jalisco
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes, Obesidad y Nutricion
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Nuevo León
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: