A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Launched by ELI LILLY AND COMPANY · Mar 3, 2022
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Malaga, , Spain
Boston, Massachusetts, United States
Fresno, California, United States
Valencia, , Spain
Santander, Cantabria, Spain
New Port Richey, Florida, United States
Louisville, Kentucky, United States
Tainan, , Taiwan
Waterbury, Connecticut, United States
Uniontown, Pennsylvania, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Barcelona, , Spain
Renton, Washington, United States
Tustin, California, United States
La Jolla, California, United States
Taipei, , Taiwan
Rockville, Maryland, United States
Gdansk, Pomorskie, Poland
Malacky, , Slovakia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Mar Del Plata, Buenos Aires, Argentina
Sevilla, Andalucía, Spain
West Des Moines, Iowa, United States
Ulsan, , Korea, Republic Of
Orange, California, United States
Osaka, , Japan
Escondido, California, United States
Tainan, , Taiwan
Chuo Ku, Tokyo, Japan
Beaver, Pennsylvania, United States
Budapest, , Hungary
Seoul, , Korea, Republic Of
Takatsuki, Osaka, Japan
Guri Si, , Korea, Republic Of
Alzira, , Spain
Houston, Texas, United States
Ansan Si, , Korea, Republic Of
Chuo Ku, Tokyo, Japan
Dallas, Texas, United States
Miami, Florida, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Idaho Falls, Idaho, United States
Sevilla, , Spain
Columbus, Ohio, United States
Piotrkow Trybunalski, , Poland
Beaumont, Texas, United States
Huntington Park, California, United States
Krakow, , Poland
Gyeongsan Si, Kyǒngsangbuk Do, Korea, Republic Of
Ulsan, Ulsan Kwangyǒkshi, Korea, Republic Of
Lodz, łódzkie, Poland
San Juan, , Puerto Rico
Fargo, North Dakota, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Houston, Texas, United States
Almeria, , Spain
Sevilla, , Spain
Malaga, Andalucía, Spain
Sapporo, Hokkaido, Japan
Kumamoto, , Japan
Chuo Ku, Tokyo, Japan
Oita, , Japan
Hollywood, Florida, United States
Norman, Oklahoma, United States
Shavano Park, Texas, United States
Ocoee, Florida, United States
Huntington Park, California, United States
Mesquite, Texas, United States
Round Rock, Texas, United States
Ansan Si, Kyǒnggi Do, Korea, Republic Of
Troy, Michigan, United States
Springfield, Missouri, United States
Las Vegas, Nevada, United States
Ciudad Autónoma De Buenos Aire, Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Nagykanizsa, Zala, Hungary
Budapest, , Hungary
Budapest, , Hungary
Chuo Ku, Tokyo, Japan
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Lublin, Lubelskie, Poland
Lublin, Lubelskie, Poland
Krakow, Małopolskie, Poland
Poznan, Wielkopolskie, Poland
Poznan, Wielkopolskie, Poland
Sabinov, Prešovský Kraj, Slovakia
Puchov, Trenčiansky Kraj, Slovakia
Almeria, Almería, Spain
Mito, Ibaraki, Japan
Ciudad Autónoma De Buenos Aire, , Argentina
Malacky, Bratislavský Kraj, Slovakia
Trebisov, , Slovakia
Palma De Mallorca, , Spain
Minneapolis, Minnesota, United States
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
San Nicolas, Buenos Aires, Argentina
Yamato Shi, Kanagawa, Japan
San Juan, , Puerto Rico
Tainan City, Tainan, Taiwan
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Rosario, Santa Fe, Argentina
San Juan, , Puerto Rico
Mito, Ibaraki, Japan
Kamakura Shi, Kanagawa, Japan
Kashiwara, Osaka, Japan
Miyazaki, , Japan
Barcelona, Barcelona [Barcelona], Spain
Ushiku, Ibaraki, Japan
Fayette, Mississippi, United States
Zalaegerszeg, Zala, Hungary
Wierzchosławice, Małopolskie, Poland
Ruda Slaska, śląskie, Poland
Concord, California, United States
Balatonfüred, Veszprém, Hungary
Avon, Indiana, United States
Little Rock, Arkansas, United States
Palma De Mallorca, Balears [Baleares], Spain
Lawrenceville, Georgia, United States
Albany, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Capital Federal, Buenos Air, Argentina
Caba, Ciudad Autónoma De Buenos Aire, Argentina
Capital, Córdoba, Argentina
Godoy Cruz, Mendoza, Argentina
Mihama Ku,Chiba City, Chiba, Japan
Ebina, Kanagawa, Japan
Saitama Shi, Saitama, Japan
Oyama, Tochigi, Japan
Chuncheon Si, Kang Won Do, Korea, Republic Of
Wonju, Kang Won Do, Korea, Republic Of
Guri Si, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teuk, Korea, Republic Of
Lublin, Lubelskie, Poland
Piotrkow Trybunalski, łódzkie, Poland
Kosice, Košický Kraj, Slovakia
Trebisov, Košický Kraj, Slovakia
Bratislava, , Slovakia
Dolny Kubin, žilinský Kraj, Slovakia
A Coruña, A Coruña [La Coruña], Spain
Seville, Sevilla, Spain
Alzira, Valenciana, Comunitat, Spain
Valencia, Valenciana, Comunitat, Spain
Taichung City, Taichung, Taiwan
Taichung City, Taichung, Taiwan
New Taipei, , Taiwan
Buenos Aires, Ciudad Aut, Argentina
Norman, Oklahoma, United States
Norman, Oklahoma, United States
A Coruña, A Coruña [La Coruña], Spain
Lawrenceville, Georgia, United States
Ciudad Autónoma De Buenos Aire, Buenos Air, Argentina
Mar Del Plata, Buenos Air, Argentina
San Nicolas, Buenos Air, Argentina
Ciudad Autonoma De Buenos Aire, Buenos Air, Argentina
Buenos Aires, Ciudad Aut, Argentina
Godoy Cruz, Mendoza, Argentina
Ciudad Autónoma De Buenos Aire, Buenos Air, Argentina
Puchov, , Slovakia
Caba, Ciudad Aut, Argentina
Dallas, Texas, United States
Piotrkow Trybunalski, łódzkie, Poland
Budapest, , Hungary
San Juan, , Puerto Rico
Kosice, Košický Kraj, Slovakia
Trebisov, Košický Kraj, Slovakia
Wonju, Kang Won Do, Korea, Republic Of
Lodz, łódzkie, Poland
Krakow, Małopolskie, Poland
Sabinov, , Slovakia
Tarnów, Małopolskie, Poland
Buenos Aires, Ciudad Aut, Argentina
Kosice, Košický Kraj, Slovakia
Taichung City, Taichung, Taiwan
Seoul, Seoul Teuk, Korea, Republic Of
A Coruña, , Spain
Chuo Ku, Tokyo, Japan
Lodz, , Poland
Gyeongsan Si, , Korea, Republic Of
Balatonfüred, , Hungary
Capital, , Argentina
Tarnów, , Poland
Ruda Slaska, , Poland
Caba, , Argentina
Kosice, , Slovakia
Dolny Kubin, , Slovakia
Patients applied
Trial Officials
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)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials