A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT05275400
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 986
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Degludec Insulin Degludec Participants with be given insulin degludec SC. Insulin Efsitora Alfa Insulin Efsitora Alfa Participants will be given insulin efsitora alfa subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 26 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.
- Secondary Outcome Measures
Name Time Method Weekly Insulin dose Week 26 The weekly insulin dose calculated based on participant entry of daily or weekly insulin dose in an electronic diary.
Change from Baseline in Fasting Glucose Baseline, Week 26 Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG).
Time in Hypoglycemia Range Week 22 to Week 26 Time in hypoglycemia range defined as time in hypoglycemia with glucose \<54 mg/dL measured during the CGM session.
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Baseline, Week 26 TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatment.
Time in Range Week 22 to Week 26 Time in glucose range between 70 and 180 mg/dL inclusive measured by continued glucose monitoring (CGM) during a 4-week CGM session.
Level 2 or Level 3 Nocturnal Hypoglycemia Event Rate Baseline to Week 78 The event rate of participant-reported clinically significant nocturnal hypoglycemia (\<54 milligram/deciliter (mg/dL) or severe) measured during treatment phase.
Time in Hyperglycemia Range Week 22 to Week 26 Time in hyperglycemia range defined as time in hyperglycemia with glucose \>180 mg/dL measured during the CGM session.
Nocturnal Hypoglycemia Event Rate Baseline to Week 78 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.
Change from Baseline in Body Weight Baseline, Week 78 Change from baseline in body weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) Baseline, Week 78 DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Trial Locations
- Locations (127)
Diabetes Associates Medical Group
🇺🇸Orange, California, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
SKY Clinical Research Network Group - Hall
🇺🇸Fayette, Mississippi, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
NYC Research
🇺🇸New York, New York, United States
Centro Medico Privado CEMAIC
🇦🇷Capital, Córdoba, Argentina
Centro Diabetológico Dr. Waitman
🇦🇷Córdoba, Argentina
CENUDIAB
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Tokuyama Clinic
🇯🇵Mihama-ku,Chiba City, Chiba, Japan
Strazsahegy Medicina Bt.
🇭🇺Budapest, Hungary
Nakamoto Internal Medicine Clinic
🇯🇵Mito, Ibaraki, Japan
The Institute of Medical Science, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul-teuk, Korea, Republic of
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Łódzkie, Poland
MediVet s.r.o.
🇸🇰Malacky, Bratislavský Kraj, Slovakia
MEDI-DIA s.r.o.
🇸🇰Sabinov, Prešovský Kraj, Slovakia
CHUAC-Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, A Coruña [La Coruña], Spain
ENDIAMED s.r.o
🇸🇰Dolny Kubin, Žilinský Kraj, Slovakia
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
Clínica Juaneda
🇪🇸Palma de Mallorca, Balears [Baleares], Spain
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
Centro Periférico de Especialidades Bola Azul
🇪🇸Almeria, Almería, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario de La Ribera
🇪🇸Alzira, Valenciana, Comunitat, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Valenciana, Comunitat, Spain
Taichung Veterans General Hospital
🇨🇳Taichung City, Taichung, Taiwan
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Go Centro Medico San Nicolás
🇦🇷San Nicolas, Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina
Stat Research S.A.
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Aut, Argentina
Medical Investigations
🇺🇸Little Rock, Arkansas, United States
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
🇦🇷Godoy Cruz, Mendoza, Argentina
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Zala, Hungary
Noritake Clinic
🇯🇵Ushiku, Ibaraki, Japan
Matoba Internal Medicine Clinic
🇯🇵Ebina, Kanagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Yeungnam Univeristy Medical Center
🇰🇷Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Human Care s.r.o.
🇸🇰Kosice, Košický Kraj, Slovakia
Diacrin .s.ro.
🇸🇰Bratislava, Slovakia
Fu Jen Catholic University Hospital
🇨🇳New Taipei, Taiwan
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
DRC Gyógyszervizsgáló Központ
🇭🇺Balatonfüred, Veszprém, Hungary
Kanizsai Dorottya Korhaz
🇭🇺Nagykanizsa, Zala, Hungary
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara, Osaka, Japan
Abe Clinic
🇯🇵Oita, Japan
Korea University Ansan Hospital
🇰🇷Ansan-si, Kyǒnggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
🇵🇱Ruda Slaska, Śląskie, Poland
Areteus s.r.o.
🇸🇰Trebisov, Košický Kraj, Slovakia
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
Instituto Centenario
🇦🇷Caba, Ciudad Autónoma De Buenos Aire, Argentina
Kozawa Eye Hospital and Diabetes Center
🇯🇵Mito, Ibaraki, Japan
Oyama East Clinic
🇯🇵Oyama, Tochigi, Japan
CenterMed Lublin NZOZ
🇵🇱Lublin, Lubelskie, Poland
OMEDICA Medical Center
🇵🇱Poznan, Wielkopolskie, Poland
DIA-MED CENTRUM s.r.o.
🇸🇰Puchov, Slovakia
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Instituto Médico Catamarca IMEC
🇦🇷Rosario, Santa Fe, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Aut, Argentina
CEMEDIC
🇦🇷Buenos Aires, Argentina
Shimizu Clinic Fusa
🇯🇵Saitama-shi, Saitama, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo Ku, Tokyo, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Yonsei University-Wonju Severance Christian Hospital
🇰🇷Wonju, Kang-won-do, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Kyǒnggi-do, Korea, Republic of
Szent Margit Rendelointézet
🇭🇺Budapest, Hungary
Szent János Kórház
🇭🇺Budapest, Hungary
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Yuri Ono Clinic
🇯🇵Sapporo, Hokkaido, Japan
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Jinnouchi Hospital
🇯🇵Kumamoto, Japan
Heiwadai Hospital
🇯🇵Miyazaki, Japan
AMC Nishiumeda Clinic
🇯🇵Osaka, Japan
Kangwon National University Hospital
🇰🇷Chuncheon-si, Kang-won-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of
NZOZ Medica
🇵🇱Lublin, Lubelskie, Poland
NZOZ Diab-Endo-Met
🇵🇱Krakow, Małopolskie, Poland
Private Practice - Dr. Robert Witek
🇵🇱Tarnów, Małopolskie, Poland
Gaja Poradnie Lekarskie Maciej Wiza
🇵🇱Poznan, Wielkopolskie, Poland
IRMED
🇵🇱Piotrkow Trybunalski, Łódzkie, Poland
Mgcendo Llc
🇵🇷San Juan, Puerto Rico
Vithas Hospital Sevilla
🇪🇸Seville, Sevilla, Spain
Chi Mei Medical Center
🇨🇳Tainan City, Tainan, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taichung, Taiwan
John Muir Physician Network Research Center
🇺🇸Concord, California, United States
AMCR Institute
🇺🇸Escondido, California, United States
National Research Institute - Huntington Park
🇺🇸Huntington Park, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Scripps Whittier Diabetes Institute
🇺🇸La Jolla, California, United States
Balanced Life Health Care Solutions/SKYCRNG
🇺🇸Lawrenceville, Georgia, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Albany Medical College, Division of Community Endocrinology
🇺🇸Albany, New York, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Jefferson Clinical Research Institute (JCRI)
🇺🇸Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Gabinety TERPA
🇵🇱Lublin, Lubelskie, Poland
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
🇪🇸Sevilla, Spain
New Horizon Research Center
🇺🇸Miami, Florida, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
HealthPartners Institute dba International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States