A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes
A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes
The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.
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
Are insulin naïve.
Exceptions:
short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
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
Springfield, Illinois 62711, United States
Hyattsville, Maryland 20782, United States
North Richland Hills, Texas 76180, United States
Hengshui Shi, Hebei 053000, China
Luoyang Shi, Henan 471003, China
Chrudim III, Chrudim 537 01, Czechia
Pardubice V, Pardubice 530 02, Czechia
Ludwigshafen am Rhein, Rhineland-Palatinate 67059, Germany
Saint Ingbert, Saarland 66386, Germany
Fukuyama-shi, Hiroshima 721-0927, Japan
Yamato-shi, Kanagawa 242-0004, Japan
Saitama-shi, Saitama 336-0967, Japan
Arakawa-ku, Tokyo 116-0012, Japan
Chuo-ku, Tokyo 104-0031, Japan
Hachioji-shi, Tokyo 192-0083, Japan
Ootaku, Tokyo 143-0015, Japan