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

Diabetes Clinical Trial

— QWINT-5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463744
• Other study ID #: 18263
• Secondary ID: I8H-MC-BDCY2021-
• Status: Completed
• Phase: Phase 3
• Start date: August 12, 2022
• Est. completion date: May 7, 2024

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Argentina	Investigaciones Medicas Imoba Srl	Balvanera	Ciudad Autónoma De Buenos Aire
Argentina	Instituto Médico Especializado (IME)	Buenos Aires
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	CEDIC	Caba	Buenos Aires
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	Centro Medico Privado San Vicente Diabetes	Cordoba	Córdoba
Argentina	Centro Diabetológico Dr. Waitman	Córdoba
Argentina	CIPADI - Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Mendoza
Argentina	CIAD Moron	Moron	Buenos Air
Argentina	Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L	San Miguel de Tucuman	Tucumán
Argentina	Centro Medico Privado de Reumatologia	San Miguel De Tucumán	Tucumán
Argentina	Centro de Salud e Investigaciones Médicas	Santa Rosa	La Pampa
Japan	The Institute for Adult Disease, Asahi Life Foundation	Chuo-ku	Tokyo
Japan	Clinic Masae Minami	Fukuoka
Japan	Hachioji Diabetes Clinic	Hachioji-shi	Tokyo
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Jinnouchi Hospital	Kumamoto
Japan	MinamiAkatsukaClinic	Mito	Ibaraki
Japan	Heiwadai Hospital	Miyazaki
Japan	Tosaki Clinic for Diabetes and Endocrinology	Nagoya-shi	Aichi
Japan	Nakakinen clinic	Naka	Ibaraki
Japan	Abe Clinic	Oita
Japan	Shimizu Clinic Fusa	Saitama-shi	Saitama
Japan	Manda Memorial Hospital	Sapporo	Hokkaido
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	Noritake Clinic	Ushiku	Ibaraki
Poland	NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny	Bialystok	Podlaskie
Poland	SN ZOZ Lege Artis Poradnia Diabetologiczna	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET	Krakow	Malopolskie
Poland	Gabinety TERPA	Lublin	Lubelskie
Poland	NZOZ Medica	Lublin	Lubelskie
Poland	Centrum Medyczne "Diabetika"	Radom	Mazowieckie
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa	Mazowieckie
Poland	NBR Polska	Warszawa	Mazowiecki
Poland	Private Practice - Dr. Janusz Gumprecht	Zabrze	Slaskie
Puerto Rico	Advanced Clinical Research, LLC	Bayamon
Puerto Rico	Endocrinologist Metabolic Clinic & Research Institute	San Juan
Slovakia	ENDIAMED s.r.o	Dolny Kubin	Žilinský Kraj
Slovakia	Funkystuff	Nove Zamky	Nitriansky Kraj
Slovakia	Tatratrial s.r.o.	Rožnava	Košický Kraj
Taiwan	Changhua Christian Hospital	Changhua County	Changhua
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 City	Taipei
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Research Foundation of SUNY - University of Buffalo	Buffalo	New York
United States	John Muir Physician Network Research Center	Concord	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Northeast Research Institute (NERI)	Fleming Island	Florida
United States	Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida
United States	Valley Research	Fresno	California
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Amir A Hassan, MD, PA	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	MedStar Health Research Institute (MedStar Physician Based Research Network)	Hyattsville	Maryland
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Palm Research Center Sunset	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	East Coast Institute for Research at The Jones Center	Macon	Georgia
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	NYU Langone Hospital - Long Island	Mineola	New York
United States	Catalina Research Institute, LLC	Montclair	California
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	NYC Research	New York	New York
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Hanson Clinical Research Center	Port Charlotte	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Clinvest Research LLC	Springfield	Missouri
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	University Clinical Investigators, Inc.	Tustin	California
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,  Japan,  Poland,  Puerto Rico,  Slovakia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 26
Secondary	Time in Glucose Range	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
Secondary	Nocturnal Hypoglycemia Event Rate	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
Secondary	Change from Baseline in Fasting Glucose	Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).	Baseline, Week 26
Secondary	Glucose Variability	Glucose variability measured by CGM 4 weeks prior to week 26	Week 22 to Week 26
Secondary	Basal Insulin Dose		Week 26
Secondary	Bolus Insulin Dose		Week 26
Secondary	Total Insulin Dose		Week 26
Secondary	Rate of Composite Level 2 and 3 Hypoglycemia Events		Baseline to Week 52
Secondary	Change from Baseline in Body Weight		Baseline, Week 26
Secondary	Time in Hypoglycemia Range	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
Secondary	Time in Hyperglycemia Range	Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26.	Week 22 to Week 26
Secondary	Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)	DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.	Baseline, Week 26
Secondary	Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores	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

External Links

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