A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
Launched by ELI LILLY AND COMPANY · May 2, 2022
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
- • Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
- • Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
- • These antihyperglycemic medications are accepted in the study
- • dipeptidyl peptidase-4 (DPP-4) inhibitors
- • sodium-glucose cotransporter 2 (SGLT2) inhibitors
- • biguanides, such as metformin
- • alpha-glucosidase inhibitors
- • glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
- • Sulfonylureas, or
- • Thiazolidinediones.
- • Are insulin naïve.
- Exceptions:
- • short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
- • Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).
- Exclusion Criteria:
- • Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
- • Have a history of greater than (\>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
- • Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- • Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
- • Acute myocardial infarction
- • Cerebrovascular accident (stroke), or
- • Coronary bypass surgery.
- • Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
- • Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.
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
Fresno, California, United States
Golden, Colorado, United States
Beijing, Beijing, China
Changsha, Hunan, China
Changchun, Jilin, China
Nanjing, Jiangsu, China
Tianjin, Tianjin, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Wuxi, Jiangsu, China
Shenyang, Liaoning, China
Nanchang, Jiangxi, China
Seoul, , Korea, Republic Of
Changsha, Hunan, China
Athens, , Greece
Suzhou, Jiangsu, China
Rockville, Maryland, United States
Nagoya, Aichi, Japan
Harbin, Heilongjiang, China
Beijing, Beijing, China
Shanghai, Shanghai, China
Brampton, Ontario, Canada
Hangzhou, Zhejiang, China
Harbin, Heilongjiang, China
Ningbo, Zhejiang, China
West Des Moines, Iowa, United States
Nanjing, Jiangsu, China
Jacksonville, Florida, United States
Bridgeport, Connecticut, United States
Calgary, Alberta, Canada
Chuo Ku, Tokyo, Japan
Yueyang, Hunan, China
Santa Ana, California, United States
Jinan, Shandong, China
Montclair, California, United States
Zhenjiang, Jiangsu, China
Caguas, , Puerto Rico
Guri Si, , Korea, Republic Of
Houston, Texas, United States
Monroe, North Carolina, United States
East Syracuse, New York, United States
Chuo Ku, Tokyo, Japan
Dallas, Texas, United States
Evansville, Indiana, United States
Oldenburg, Schleswig Holstein, Germany
Sarnia, Ontario, Canada
Nanjing, Jiangsu, China
Cheng Du, Sichuan, China
Brampton, Ontario, Canada
Owensboro, Kentucky, United States
Houston, Texas, United States
São Paulo, , Brazil
Harbin, Nangang District, China
Essen, Nordrhein Westfalen, Germany
Kumamoto, , Japan
Chitose, Hokkaido, Japan
Kumamoto, , Japan
Oita, , Japan
Norman, Oklahoma, United States
Chongqing, Chongqing, China
Shavano Park, Texas, United States
Cangzhou, Hebei, China
Chengdu, Sichuan, China
Ridgeland, Mississippi, United States
Mesquite, Texas, United States
Athens, Attikí, Greece
Greenbrae, California, United States
Bowling Green, Kentucky, United States
Springfield, Missouri, United States
Westfield, New York, United States
Greenville, South Carolina, United States
São Paulo, , Brazil
Krnov, Moravskoslezský Kraj, Czechia
Praha, Praha 4, Czechia
Wangen, Baden Württemberg, Germany
Essen, Nordrhein Westfalen, Germany
Ludwigshafen Am Rhein, Rheinland Pfalz, Germany
Hamburg, , Germany
Paleo Faliro, Attikí (Region), Greece
Thessaloniki, Thessaloníki, Greece
Athens, , Greece
Ootaku, Tokyo, Japan
Changzhou, Jiangsu, China
Natal, Rio Grande Do Norte, Brazil
Saint Ingbert, Saarland, Germany
Luoyang Shi, Henan, China
Springfield, Illinois, United States
Sao Paulo, São Paulo, Brazil
Yamato Shi, Kanagawa, Japan
Vitória, Espírito Santo, Brazil
Curitiba, Paraná, Brazil
Union City, Georgia, United States
Hyattsville, Maryland, United States
North Richland Hills, Texas, United States
Campinas, São Paulo, Brazil
Morehead City, North Carolina, United States
Nagoya Shi, Aichi, Japan
Kashiwa, Chiba, Japan
Fukuyama Shi, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Naka, Ibaraki, Japan
Chigasaki, Kanagawa, Japan
Hachioji, Tokyo, Japan
Union City, Georgia, United States
Guaynabo, , Puerto Rico
Changsha, Hunan, China
Harbin, Heilongjiang, China
East Syracuse, New York, United States
Monterrey, Nuevo León, Mexico
Canton, Georgia, United States
Chihuahua, , Mexico
Philadelphia, Pennsylvania, United States
Mihama Ku,Chiba City, Chiba, Japan
Saitama Shi, Saitama, Japan
Oyama, Tochigi, Japan
Chuncheon Si, Kang Won Do, Korea, Republic Of
Guri Si, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teuk, Korea, Republic Of
Zhenjiang, Jiangsu, China
Escondido, California, United States
Bowling Green, Kentucky, United States
Spokane, Washington, United States
Rio De Janeiro, , Brazil
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Montreal, Quebec, Canada
Beijing, Beijing, China
Changping, Beijing, China
Hengshui Shi, Hebei, China
Nanjing Shi, Jiangsu, China
Wuxi Shi, Jiangsu, China
Shanghai, Shanghai, China
Tianjin, Tianjin, China
Wuxi, , China
Chrudim Iii, Chrudim, Czechia
Ceske Budejovice, Jihočeský, Czechia
Opocno, Královéhradecký Kraj, Czechia
Krnov, Moravskosl, Czechia
Brandys Nad Labem, Praha Vých, Czechia
Pardubice, , Czechia
Dresden, Sachsen, Germany
Mito, Ibaraki, Japan
Arakawa Ku, Tokyo, Japan
Shinjuku, Tokyo, Japan
Norman, Oklahoma, United States
Norman, Oklahoma, United States
Pardubice V, Pardubice, Czechia
Rio De Janeiro, , Brazil
Wuxi, Jiangsu, China
Campinas, São Paulo, Brazil
Wangen Im Allgäu, Baden Württemberg, Germany
Dallas, Texas, United States
Ridgeland, Mississippi, United States
Harbin, Nangang District, China
Ridgeland, Mississippi, United States
Ceske Budejovice, Jihočeský Kraj, Czechia
Tianjin, Tianjin, China
Cheng Du, Sichuan, China
Cangzhou, Hebei, China
Guaynabo, , Puerto Rico
Hachioji Shi, Tokyo, Japan
Brampton, Ontario, Canada
Thermi,Thessaloniki, Thessaloníki, Greece
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Brandys Nad Labem, Praha Východ, Czechia
Opocno, Rychnov Nad Kněžnou, Czechia
Wangen, , Germany
São Paulo, , Brazil
Athens, Attikí, Greece
Sao Paulo, , Brazil
Natal, Rio Grande Do Norte, Brazil
Changzhou, Jiangsu, China
Campinas, , Brazil
Vitória, , Brazil
Ceske Budejovice, , Czechia
Krnov, , Czechia
Brandys Nad Labem, , Czechia
Paleo Faliro, , Greece
Curitiba, , Brazil
Praha, , Czechia
Opocno, , Czechia
Wangen Im Allgäu, , Germany
Thessaloniki, , Greece
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
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