A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Key facts

Study ID

NCT05275400

Run by

Eli Lilly and Company

People needed

986

Starts

2022-03-08

Expected to finish

2024-05-15

Last updated by the study team

2025-06-03

Who can join

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

You may qualify if…

• Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
• Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
• Have HbA1c value of 6.5% - 10% inclusive, at screening
• Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
• Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
• once daily U100 or U200 of insulin degludec
• once daily U100 or U300 of insulin glargine
• once or twice daily U100 of insulin detemir, or
• once or twice daily human insulin NPH
• acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
• dipeptidyl peptidase (DPP-4) IV inhibitors
• SGLT2 inhibitors
• metformin
• alphaglucosidase inhibitors or,
• Glucagon-Like Peptide-1 (GLP-1) receptor agonists
• Participants must be willing to stay on stable dose throughout the study

You may not qualify if…

• Have Type 1 diabetes mellitus
• Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
• Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
• Have active or untreated malignancy
• Are pregnant
• Have a significant weight gain or loss the past 3 months
• Have received anytime in the past 6 months, any of the following insulin therapies:
• prandial insulin
• insulin mixtures
• inhaled insulin
• U-500 insulin, or
• continuous subcutaneous insulin infusion therapy
• Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
• acute myocardial infarctions
• cerebrovascular accident (stroke), or
• coronary bypass surgery
• Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Where it is running

• John Muir Physician Network Research Center — Concord, California, United States
• AMCR Institute — Escondido, California, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States
• Scripps Whittier Diabetes Institute — La Jolla, California, United States
• Diabetes Associates Medical Group — Orange, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Encore Medical Research — Hollywood, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville, Georgia, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
• HealthPartners Institute dba International Diabetes Center — Minneapolis, Minnesota, United States
• SKY Clinical Research Network Group - Hall — Fayette, Mississippi, United States
• Clinvest Research LLC — Springfield, Missouri, United States
• Palm Research Center Tenaya — Las Vegas, Nevada, United States
• Albany Medical College, Division of Community Endocrinology — Albany, New York, United States
• NYC Research — New York, New York, United States
• Lillestol Research — Fargo, North Dakota, United States
• Medical Investigations — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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