A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

18263

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

2022-08-12

2024-05-06

2024-05-06

Active (not recruiting)

Early phase I

692

Inclusion Criteria: * Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening * Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening * Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening. * Have a body mass index of ≤35 kilogram/square meter (kg/m²) Exclusion Criteria: * Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes * Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening. * Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 692, 'type': 'ACTUAL'}}

2024-04-16