Clinical trial NCT05275400: A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Official title: A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 986
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 reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
* Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
* Have HbA1c value of 6.5% - 10% inclusive, at screening
* Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
* Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

  * once daily U100 or U200 of insulin degludec
  * once daily U100 or U300 of insulin glargine
  * once or twice daily U100 of insulin detemir, or
  * once or twice daily human insulin NPH
* acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

  * dipeptidyl peptidase (DPP-4) IV inhibitors
  * SGLT2 inhibitors
  * metformin
  * alphaglucosidase inhibitors or,
  * Glucagon-Like Peptide-1 (GLP-1) receptor agonists
  * Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria:

* Have Type 1 diabetes mellitus
* Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
* Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
* Have active or untreated malignancy
* Are pregnant
* Have a significant weight gain or loss the past 3 months
* Have received anytime in the past 6 months, any of the following insulin therapies:

  * prandial insulin
  * insulin mixtures
  * inhaled insulin
  * U-500 insulin, or
  * continuous subcutaneous insulin infusion therapy
* Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

  * acute myocardial infarctions
  * cerebrovascular accident (stroke), or
  * coronary bypass surgery
* Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]
timeFrame: Baseline, Week 26
measure: Nocturnal Hypoglycemia Event Rate
timeFrame: Baseline up to Week 78
measure: Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L)
timeFrame: Week 22 to Week 26
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, Week 26
measure: Weekly Insulin Dose at Week 26
timeFrame: Week 26
measure: Hypoglycemia Event Rate
timeFrame: Baseline up to Week 78
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 78
measure: Percentage of Time in Hypoglycemia Range
timeFrame: Week 22 to Week 26
measure: Percentage of Time in Hyperglycemia Range
timeFrame: Week 22 to Week 26
measure: Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
timeFrame: Baseline, Week 26, Week 52, Week 78
measure: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26
timeFrame: Week 26
measure: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52
timeFrame: Week 52
measure: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78
timeFrame: Week 78
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Medical Investigations
state: Arkansas
city: Concord
country: United States
facility: John Muir Physician Network Research Center
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Orange
country: United States
facility: Diabetes Associates Medical Group
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
city: Fayette
country: United States
facility: SKY Clinical Research Network Group - Hall
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Albany
country: United States
facility: Albany Medical College, Division of Community Endocrinology
state: New York
city: New York
country: United States
facility: NYC Research
state: New York
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Clinical Research Institute (JCRI)
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
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: San Nicolas
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Air
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Stat Research S.A.
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Aut
city: Caba
country: Argentina
facility: Instituto Centenario
state: Ciudad Autónoma De Buenos Aire
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC
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 Catamarca IMEC
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: CENUDIAB
city: Córdoba
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ
state: Veszprém
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Korhaz
state: Zala
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház
state: Zala
city: Budapest
country: Hungary
facility: Szent Margit Rendelointézet
city: Budapest
country: Hungary
facility: Szent János Kórház
city: Budapest
country: Hungary
facility: Strazsahegy Medicina Bt.
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Sapporo
country: Japan
facility: Yuri Ono Clinic
state: Hokkaido
city: Mito
country: Japan
facility: Nakamoto Internal Medicine Clinic
state: Ibaraki
city: Mito
country: Japan
facility: Kozawa Eye Hospital and Diabetes Center
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic
state: Ibaraki
city: Ebina
country: Japan
facility: Matoba Internal Medicine Clinic
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Saitama-shi
country: Japan
facility: Shimizu Clinic Fusa
state: Saitama
city: Oyama
country: Japan
facility: Oyama East Clinic
state: Tochigi
city: Chuo Ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Kumamoto
country: Japan
facility: Jinnouchi Hospital
city: Miyazaki
country: Japan
facility: Heiwadai Hospital
city: Oita
country: Japan
facility: Abe Clinic
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Chuncheon-si
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Kang-won-do
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital
state: Kang-won-do
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Kyǒnggi-do
city: Gyeongsan-si
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Kyǒngsangbuk-do
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teuk
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan-Kwangyǒkshi
city: Lublin
country: Poland
facility: CenterMed Lublin NZOZ
state: Lubelskie
city: Lublin
country: Poland
facility: Gabinety TERPA
state: Lubelskie
city: Lublin
country: Poland
facility: NZOZ Medica
state: Lubelskie
city: Krakow
country: Poland
facility: NZOZ Diab-Endo-Met
state: Małopolskie
city: Tarnów
country: Poland
facility: Private Practice - Dr. Robert Witek
state: Małopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Poznan
country: Poland
facility: OMEDICA Medical Center
state: Wielkopolskie
city: Poznan
country: Poland
facility: Gaja Poradnie Lekarskie Maciej Wiza
state: Wielkopolskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Piotrkow Trybunalski
country: Poland
facility: IRMED
state: Łódzkie
city: Ruda Slaska
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
state: Śląskie
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Mgcendo Llc
city: Malacky
country: Slovakia
facility: MediVet s.r.o.
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Human Care s.r.o.
state: Košický Kraj
city: Trebisov
country: Slovakia
facility: Areteus s.r.o.
state: Košický Kraj
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
state: Prešovský Kraj
city: Bratislava
country: Slovakia
facility: Diacrin .s.ro.
city: Puchov
country: Slovakia
facility: DIA-MED CENTRUM s.r.o.
city: Dolny Kubin
country: Slovakia
facility: ENDIAMED s.r.o
state: Žilinský Kraj
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Almeria
country: Spain
facility: Centro Periférico de Especialidades Bola Azul
state: Almería
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
state: Andalucía
city: Palma de Mallorca
country: Spain
facility: Clínica Juaneda
state: Balears [Baleares]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Seville
country: Spain
facility: Vithas Hospital Sevilla
state: Sevilla
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Valenciana, Comunitat
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
state: Taichung
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
state: Tainan
city: New Taipei
country: Taiwan
facility: Fu Jen Catholic University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
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: