Clinical trial NCT05463744: A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Diabetes
Keywords: Type 1 Diabetes (T1D)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 692
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Time in Glucose Range
timeFrame: Week 23 to Week 26
measure: Nocturnal Hypoglycemia Event Rate
timeFrame: Baseline to Week 52
measure: Change from Baseline in HbA1c
timeFrame: Baseline, Week 52
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 26 and Baseline, Week 52
measure: Glucose Variability
timeFrame: Week 23 to Week 26 and Week 49 to Week 52
measure: Time in Glucose Range
timeFrame: Week 49 to Week 52
measure: Basal Insulin Dose
timeFrame: Week 26 and Week 52
measure: Bolus Insulin Dose
timeFrame: Week 26 and Week 52
measure: Total Insulin Dose
timeFrame: Week 26 and Week 52
measure: Rate of Composite Level 2 and 3 Hypoglycemia Events
timeFrame: Baseline to Week 52
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 26 and Baseline, Week 52
measure: Time in Hypoglycemia Range
timeFrame: Week 23 to Week 26 and Week 49 to Week 52
measure: Time in Hyperglycemia Range
timeFrame: Week 23 to Week 26 and Week 49 to Week 52
measure: Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
timeFrame: Baseline, Week 26 and Baseline, Week 52
measure: Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores
timeFrame: Baseline, Week 26 and Baseline, Week 52
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Research Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: Fort Lauderdale
country: United States
facility: Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Hanson Clinical Research Center
state: Florida
city: Macon
country: United States
facility: East Coast Institute for Research at The Jones Center
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
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: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Hyattsville
country: United States
facility: MedStar Health Research Institute (MedStar Physician Based Research Network)
state: Maryland
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
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: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Buffalo
country: United States
facility: Research Foundation of SUNY - University of Buffalo
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: NYC Research
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Amir A Hassan, MD, PA
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: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Air
city: Moron
country: Argentina
facility: CIAD Moron
state: Buenos Air
city: Balvanera
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aire
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aire
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC
state: Córdoba
city: Cordoba
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
state: Córdoba
city: Santa Rosa
country: Argentina
facility: Centro de Salud e Investigaciones Médicas
state: La Pampa
city: Godoy Cruz
country: Argentina
facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
state: Mendoza
city: San Miguel de Tucuman
country: Argentina
facility: Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado (IME)
city: Córdoba
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Nagoya-shi
country: Japan
facility: Tosaki Clinic for Diabetes and Endocrinology
state: Aichi
city: Sapporo
country: Japan
facility: Manda Memorial Hospital
state: Hokkaido
city: Mito
country: Japan
facility: MinamiAkatsukaClinic
state: Ibaraki
city: Naka
country: Japan
facility: Nakakinen clinic
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic
state: Ibaraki
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Takatsuki
country: Japan
facility: Takatsuki Red Cross Hospital
state: Osaka
city: Saitama-shi
country: Japan
facility: Shimizu Clinic Fusa
state: Saitama
city: Chuo-ku
country: Japan
facility: The Institute for Adult Disease, Asahi Life Foundation
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Hachioji Diabetes Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Clinic Masae Minami
city: Kumamoto
country: Japan
facility: Jinnouchi Hospital
city: Miyazaki
country: Japan
facility: Heiwadai Hospital
city: Oita
country: Japan
facility: Abe Clinic
city: Lublin
country: Poland
facility: Gabinety TERPA
state: Lubelskie
city: Lublin
country: Poland
facility: NZOZ Medica
state: Lubelskie
city: Radom
country: Poland
facility: Centrum Medyczne "Diabetika"
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: NBR Polska
state: Mazowiecki
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
state: Małopolskie
city: Bialystok
country: Poland
facility: SN ZOZ Lege Artis Poradnia Diabetologiczna
state: Podlaskie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Zabrze
country: Poland
facility: Private Practice - Dr. Janusz Gumprecht
state: Śląskie
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: San Juan
country: Puerto Rico
facility: Endocrinologist Metabolic Clinic & Research Institute
city: Rožňava
country: Slovakia
facility: Tatratrial s.r.o.
state: Košický Kraj
city: Nove Zamky
country: Slovakia
facility: Funkystuff
state: Nitriansky Kraj
city: Dolny Kubin
country: Slovakia
facility: ENDIAMED s.r.o
state: Žilinský Kraj
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: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taipei
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University 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_CHAIR
References: