A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

Completed · Phase 3

Conditions studied: Type 1 Diabetes, Diabetes

In brief

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.

Key facts

Study ID

NCT05463744

Run by

Eli Lilly and Company

People needed

692

Starts

2022-08-12

Expected to finish

2024-05-07

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Valley Research — Fresno, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Northeast Research Institute (NERI) — Fleming Island, Florida, United States
• Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Hanson Clinical Research Center — Port Charlotte, Florida, United States
• East Coast Institute for Research at The Jones Center — Macon, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• MedStar Health Research Institute (MedStar Physician Based Research Network) — Hyattsville, Maryland, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Clinvest Research LLC — Springfield, Missouri, United States
• Palm Research Center Tenaya — Las Vegas, Nevada, United States
• Palm Research Center Sunset — Las Vegas, Nevada, United States
• Research Foundation of SUNY - University of Buffalo — Buffalo, New York, United States
• NYU Langone Hospital - Long Island — Mineola, New York, United States
• NYC Research — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• John Muir Physician Network Research Center — Concord, California, United States

Full record on ClinicalTrials.gov

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