A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05275400
• Other study ID #: 18237
• Secondary ID: I8H-MC-BDCU2021-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 8, 2022
• Est. completion date: May 14, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 986
• Est. completion date: May 14, 2024
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin Efsitora Alfa
Administered SC
• Insulin Degludec
Administered SC

Locations

Country	Name	City	State
Argentina	CEMEDIC	Buenos Aires
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Aut
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Aut
Argentina	Instituto Centenario	Caba	Ciudad Autónoma De Buenos Aire
Argentina	Centro Medico Privado CEMAIC	Capital	Córdoba
Argentina	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aire	Buenos Air
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	CENUDIAB	Ciudad Autónoma de Buenos Aire
Argentina	Stat Research S.A.	Ciudad Autónoma de Buenos Aire	Buenos Air
Argentina	Centro Diabetológico Dr. Waitman	Córdoba
Argentina	CIPADI - Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Mendoza
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Instituto Médico Catamarca IMEC	Rosario	Santa Fe
Argentina	Go Centro Medico San Nicolás	San Nicolas	Buenos Aires
Hungary	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém
Hungary	Strazsahegy Medicina Bt.	Budapest
Hungary	Szent János Kórház	Budapest
Hungary	Szent Margit Rendelointézet	Budapest
Hungary	Kanizsai Dorottya Korhaz	Nagykanizsa	Zala
Hungary	Zala Megyei Szent Rafael Kórház	Zalaegerszeg	Zala
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	The Institute of Medical Science, Asahi Life Foundation	Chuo-ku	Tokyo
Japan	Matoba Internal Medicine Clinic	Ebina	Kanagawa
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Shiraiwa Medical Clinic	Kashiwara	Osaka
Japan	Tokuyama Clinic	Mihama-ku,Chiba City	Chiba
Japan	Kozawa Eye Hospital and Diabetes Center	Mito	Ibaraki
Japan	Nakamoto Internal Medicine Clinic	Mito	Ibaraki
Japan	Heiwadai Hospital	Miyazaki
Japan	Abe Clinic	Oita
Japan	Shimizu Clinic Fusa	Saitama-shi	Saitama
Japan	Yuri Ono Clinic	Sapporo	Hokkaido
Japan	Noritake Clinic	Ushiku	Ibaraki
Japan	Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Kyonggi-do
Korea, Republic of	Kangwon National University Hospital	Chuncheon-si	Kang-won-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Kyonggi-do
Korea, Republic of	Yeungnam Univeristy Medical Center	Gyeongsan-si	Kyongsangbuk-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teuk
Korea, Republic of	Ulsan University Hospital	Ulsan	Ulsan-Kwangyokshi
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju	Kang-won-do
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	NZOZ Diab-Endo-Met	Krakow	Malopolskie
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz	Lódzkie
Poland	CenterMed Lublin NZOZ	Lublin	Lubelskie
Poland	Gabinety TERPA	Lublin	Lubelskie
Poland	NZOZ Medica	Lublin	Lubelskie
Poland	IRMED	Piotrkow Trybunalski	Lódzkie
Poland	Gaja Poradnie Lekarskie Maciej Wiza	Poznan	Wielkopolskie
Poland	OMEDICA Medical Center	Poznan	Wielkopolskie
Poland	NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki	Ruda Slaska	Slaskie
Poland	Private Practice - Dr. Robert Witek	Tarnów	Malopolskie
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Puerto Rico	Mgcendo Llc	San Juan
Slovakia	Diacrin .s.ro.	Bratislava
Slovakia	ENDIAMED s.r.o	Dolny Kubin	Žilinský Kraj
Slovakia	Human Care s.r.o.	Kosice	Košický Kraj
Slovakia	MediVet s.r.o.	Malacky	Bratislavský Kraj
Slovakia	DIA-MED CENTRUM s.r.o.	Puchov
Slovakia	MEDI-DIA s.r.o.	Sabinov	Prešovský Kraj
Slovakia	Areteus s.r.o.	Trebisov	Košický Kraj
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]
Spain	Centro Periférico de Especialidades Bola Azul	Almeria	Almería
Spain	Hospital Universitario de La Ribera	Alzira	Valenciana, Comunitat
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Andalucía
Spain	Clínica Juaneda	Palma de Mallorca	Balears [Baleares]
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla
Spain	Hospital Quiron Infanta Luisa	Sevilla	Andalucía
Spain	Vithas Hospital Sevilla	Seville	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia	Valenciana, Comunitat
Taiwan	Fu Jen Catholic University Hospital	New Taipei
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung City	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Medical Center	Tainan City	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Albany Medical College, Division of Community Endocrinology	Albany	New York
United States	Gadolin Research	Beaumont	Texas
United States	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania
United States	Aventiv Research Inc	Columbus	Ohio
United States	John Muir Physician Network Research Center	Concord	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	AMCR Institute	Escondido	California
United States	Lillestol Research	Fargo	North Dakota
United States	SKY Clinical Research Network Group - Hall	Fayette	Mississippi
United States	Encore Medical Research	Hollywood	Florida
United States	Juno Research	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Scripps Whittier Diabetes Institute	La Jolla	California
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Balanced Life Health Care Solutions/SKYCRNG	Lawrenceville	Georgia
United States	Medical Investigations	Little Rock	Arkansas
United States	L-MARC Research Center	Louisville	Kentucky
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	HealthPartners Institute dba International Diabetes Center	Minneapolis	Minnesota
United States	NYC Research	New York	New York
United States	Intend Research, LLC	Norman	Oklahoma
United States	West Orange Endocrinology	Ocoee	Florida
United States	Diabetes Associates Medical Group	Orange	California
United States	Jefferson Clinical Research Institute (JCRI)	Philadelphia	Pennsylvania
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Clinvest Research LLC	Springfield	Missouri
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Hungary,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)	Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin.	Baseline, Week 26
Secondary	Nocturnal Hypoglycemia Event Rate	The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase up to Week 78.	Baseline to Week 78
Secondary	Time in Range	Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session.	Week 22 to Week 26
Secondary	Change from Baseline in Fasting Glucose	Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).	Baseline, Week 26
Secondary	Weekly Insulin dose	The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.	Week 26
Secondary	Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate	The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.	Baseline to Week 78
Secondary	Change from Baseline in Body Weight	Change from baseline in body weight	Baseline, Week 78
Secondary	Time in Hypoglycemia Range	Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL measured during the CGM session.	Week 22 to Week 26
Secondary	Time in Hyperglycemia Range	Time in hyperglycemia range defined as time in hyperglycemia with glucose >180 mg/dL measured during the CGM session.	Week 22 to Week 26
Secondary	Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)	TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment.	Baseline, Week 26
Secondary	Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)	DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.	Baseline, Week 26
Secondary	Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)	DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.	Baseline, Week 78

External Links

•   A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin