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

18262

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. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

2022-06-03

2024-04-15

2024-04-15

Active (not recruiting)

Early phase I

928

Inclusion Criteria: * Have diagnosis of T2D according to the World Health Organization Criteria * Have an HbA1c of 7.0% - 10% inclusive, at screening * Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study Exclusion Criteria: * Have a diagnosis of T1D, latent autoimmune diabetes, or 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 \>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 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, ≥5%.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 928, 'type': 'ACTUAL'}}

2024-04-16