A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
- Conditions
- Type 1 DiabetesDiabetes
- Interventions
- Registration Number
- NCT05463744
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 692
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Efsitora Alfa Insulin Efsitora Alfa Participants will receive insulin efsitora alfa by subcutaneously (SC) Insulin Degludec Insulin Degludec Participants will receive insulin degludec SC
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 26
- Secondary Outcome Measures
Name Time Method Time in Glucose Range Week 49 to Week 52 Time in Glucose Range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) inclusive, measured by continuous glucose monitoring (CGM) 4 weeks prior to week 52.
Change from Baseline in Body Weight Baseline, Week 26 and Baseline, Week 52 Nocturnal Hypoglycemia Event Rate Baseline to Week 52 The event rate of participant-reported clinically significant nocturnal hypoglycemia (\<54 mg/dL or severe) measured during treatment phase up to week 52.
Change from Baseline in Fasting Glucose Baseline, Week 26 and Baseline, Week 52 Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG).
Change from Baseline in HbA1c Baseline, Week 52 Basal Insulin Dose Week 26 and Week 52 Bolus Insulin Dose Week 26 and Week 52 Total Insulin Dose Week 26 and Week 52 Rate of Composite Level 2 and 3 Hypoglycemia Events Baseline to Week 52 Glucose Variability Week 23 to Week 26 and Week 49 to Week 52 Glucose variability measured by CGM 4 weeks prior to week 26 and week 52.
Time in Hyperglycemia Range Week 23 to Week 26 and Week 49 to Week 52 Time in hyperglycemia range defined as glucose \>180 mg/dL, measured by CGM 4 weeks prior to week 26 and week 52.
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) Baseline, Week 26 and Baseline, Week 52 DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Time in Hypoglycemia Range Week 23 to Week 26 and Week 49 to Week 52 Time in hypoglycemia range defined as time in hypoglycemia with glucose \<54 mg/dL, measured by CGM 4 weeks prior to week 26 and week 52.
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores Baseline, Week 26 and Baseline, Week 52 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.
Trial Locations
- Locations (82)
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Amir A Hassan, MD, PA
🇺🇸Houston, Texas, United States
Sansum Diabetes Research Institute
🇺🇸Santa Barbara, California, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Valley Research
🇺🇸Fresno, California, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
🇺🇸Fort Lauderdale, Florida, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Instituto Médico Especializado (IME)
🇦🇷Buenos Aires, Argentina
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
John Muir Physician Network Research Center
🇺🇸Concord, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Hanson Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
NYC Research
🇺🇸New York, New York, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
East Coast Institute for Research at The Jones Center
🇺🇸Macon, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Consultorio de Investigación ClÃnica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Manda Memorial Hospital
🇯🇵Sapporo, Hokkaido, Japan
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
CIAD Moron
🇦🇷Moron, Buenos Air, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Balvanera, Ciudad Autónoma De Buenos Aire, Argentina
Abe Clinic
🇯🇵Oita, Japan
Hachioji Diabetes Clinic
🇯🇵Hachioji-shi, Tokyo, Japan
NBR Polska
🇵🇱Warszawa, Mazowiecki, Poland
Centro Medico Privado CEMAIC
🇦🇷Capital, Córdoba, Argentina
NZOZ Medica
🇵🇱Lublin, Lubelskie, Poland
Advanced Clinical Research, LLC
🇵🇷Bayamon, Puerto Rico
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
🇦🇷Godoy Cruz, Mendoza, Argentina
Shimizu Clinic Fusa
🇯🇵Saitama-shi, Saitama, Japan
Jinnouchi Hospital
🇯🇵Kumamoto, Japan
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Centro Diabetológico Dr. Waitman
🇦🇷Córdoba, Argentina
Tosaki Clinic for Diabetes and Endocrinology
🇯🇵Nagoya-shi, Aichi, Japan
Private Practice - Dr. Janusz Gumprecht
🇵🇱Zabrze, Śląskie, Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
🇵🇱Krakow, Małopolskie, Poland
Centrum Medyczne "Diabetika"
🇵🇱Radom, Mazowieckie, Poland
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taichung, Taiwan
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Gabinety TERPA
🇵🇱Lublin, Lubelskie, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Endocrinologist Metabolic Clinic & Research Institute
🇵🇷San Juan, Puerto Rico
Tatratrial s.r.o.
🇸🇰Rožňava, Košický Kraj, Slovakia
Funkystuff
🇸🇰Nove Zamky, Nitriansky Kraj, Slovakia
ENDIAMED s.r.o
🇸🇰Dolny Kubin, Žilinský Kraj, Slovakia
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
SN ZOZ Lege Artis Poradnia Diabetologiczna
🇵🇱Bialystok, Podlaskie, Poland
Centro de Salud e Investigaciones Médicas
🇦🇷Santa Rosa, La Pampa, Argentina
ClÃnica 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
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
The Institute for Adult Disease, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
🇵🇱Bialystok, Podlaskie, Poland
Chi Mei Medical Center
🇨🇳Tainan City, Tainan, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung City, Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taipei, Taiwan
MinamiAkatsukaClinic
🇯🇵Mito, Ibaraki, Japan
Nakakinen clinic
🇯🇵Naka, Ibaraki, Japan
Noritake Clinic
🇯🇵Ushiku, Ibaraki, Japan
Clinic Masae Minami
🇯🇵Fukuoka, Japan
Heiwadai Hospital
🇯🇵Miyazaki, Japan
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Centro Medico Privado San Vicente Diabetes
🇦🇷Cordoba, Córdoba, Argentina
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
🇺🇸Hyattsville, Maryland, United States
Research Foundation of SUNY - University of Buffalo
🇺🇸Buffalo, New York, United States
Palm Research Center Sunset
🇺🇸Las Vegas, Nevada, United States
CEDIC
🇦🇷Caba, Buenos Aires, Argentina